Pain Clinical Trial
Official title:
The Use of Glutathione (GSH) for Prevention of Paclitaxel/Carboplatin (TAXOL/CBDCA) Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind Placebo Controlled Study
Verified date | May 2013 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This randomized phase III trial is studying glutathione to see how well it works in preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as glutathione, may help prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known whether glutathione is more effective than a placebo in preventing peripheral neuropathy.
Status | Completed |
Enrollment | 282 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Scheduled to undergo treatment with TAXOL at 150-200 mg/m2 and CBDCA at area under the curve (AUC) = 5-7 every 21 or 28 days for at least 12 weeks; alternatively, paclitaxel can be prescribed at 80 mg/m2 weekly for at least 12 weeks, with the same CBDCA dose of AUC = 5-7 every 21 days; additional chemotherapy agents are allowed (bevacizumab, etoposide, etc) per physician discretion, as long as they are not known to be neurotoxic; Note: patients ideally will begin GSH therapy prior to their first dose of this chemotherapy, but must begin GSH therapy prior to their second dose of chemotherapy - Ability to sign informed consent and understand the nature of a placebo-controlled trial - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Ability to complete English language questionnaire(s) by themselves or with assistance - Life expectancy >= 6 months - Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only, per clinician discretion - Willingness to provide blood specimens as required by the protocol - White blood cell (WBC) >= 3400 - Absolute neutrophil count (ANC) >= 1500 - Platelet (PLT) >= 100,000 - Hemoglobin (HgB) > 10.0 - Creatinine =< 1.5 x upper limit of normal (ULN) Exclusion Criteria: - Pre-existing history of peripheral neuropathy > grade 1 (National Cancer Institute [NCI] CTCAE version [v] 4.0) due to any cause (e.g., chemotherapy, diabetes, alcohol, toxin, or heredity) - Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient - Any of the following: - Pregnant women - Nursing women - Women of childbearing potential who are unwilling to employ adequate contraception - Prior TAXOL and/or CBDCA chemotherapy treatment (other than the current treatment regimen) - Concurrent use of any agent being used specifically to prevent or treat neuropathy, including but not limited to the following: - Gabapentin - Glutamine powder or glutamine tablets - Vitamin B6 or E |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Abington Memorial Hospital | Abington | Pennsylvania |
United States | Pali Momi Medical Center | Aiea | Hawaii |
United States | Akron General Medical Center | Akron | Ohio |
United States | Summa Akron City Hospital/Cooper Cancer Center | Akron | Ohio |
United States | Phoebe Putney Memorial Hospital | Albany | Georgia |
United States | Medini, Eitan MD (UIA Investigator) | Alexandria | Minnesota |
United States | McFarland Clinic PC-William R Bliss Cancer Center | Ames | Iowa |
United States | AnMed Health Cancer Center | Anderson | South Carolina |
United States | Michigan Cancer Research Consortium CCOP | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | Randolph Hospital | Asheboro | North Carolina |
United States | Atlanta Regional CCOP | Atlanta | Georgia |
United States | Northside Hospital | Atlanta | Georgia |
United States | Piedmont Hospital | Atlanta | Georgia |
United States | Saint Joseph's Hospital of Atlanta | Atlanta | Georgia |
United States | Georgia Regents University Medical Center | Augusta | Georgia |
United States | Harold Alfond Center for Cancer Care | Augusta | Maine |
United States | The Medical Center of Aurora | Aurora | Colorado |
United States | Well Star Cobb Hospital | Austell | Georgia |
United States | Eastern Maine Medical Center | Bangor | Maine |
United States | Summa Barberton Hospital | Barberton | Ohio |
United States | Ochsner Health Center-Summa | Baton Rouge | Louisiana |
United States | Saint Francis Hospital and Health Centers | Beech Grove | Indiana |
United States | Mary Rutan Hospital | Bellefontaine | Ohio |
United States | PeaceHealth Saint Joseph Medical Center | Bellingham | Washington |
United States | Constantinou, Costas L MD (UIA Investigator) | Bettendorf | Iowa |
United States | Hematology Oncology Associates-Quad Cities | Bettendorf | Iowa |
United States | Billings Clinic Cancer Center | Billings | Montana |
United States | Frontier Cancer Center and Blood Institute-Billings | Billings | Montana |
United States | Montana Cancer Consortium CCOP | Billings | Montana |
United States | Northern Rockies Radiation Oncology Center | Billings | Montana |
United States | Saint Vincent Healthcare | Billings | Montana |
United States | Mid Dakota Clinic | Bismarck | North Dakota |
United States | Saint Alexius Medical Center | Bismarck | North Dakota |
United States | Sanford Bismarck Medical Center | Bismarck | North Dakota |
United States | Illinois CancerCare-Bloomington | Bloomington | Illinois |
United States | Saint Joseph Medical Center | Bloomington | Illinois |
United States | Boulder Community Hospital | Boulder | Colorado |
United States | Bozeman Deaconess Cancer Center | Bozeman | Montana |
United States | Bozeman Deaconess Hospital | Bozeman | Montana |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | Saint James Community Hospital and Cancer Treatment Center | Butte | Montana |
United States | Graham Hospital Association | Canton | Illinois |
United States | Illinois CancerCare-Canton | Canton | Illinois |
United States | Illinois CancerCare-Carthage | Carthage | Illinois |
United States | Memorial Hospital | Carthage | Illinois |
United States | Rocky Mountain Oncology | Casper | Wyoming |
United States | Cedar Rapids Oncology Association | Cedar Rapids | Iowa |
United States | Mercy Hospital | Cedar Rapids | Iowa |
United States | Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa |
United States | Providence Regional Cancer System-Centralia | Centralia | Washington |
United States | Cancer Center of Kansas - Chanute | Chanute | Kansas |
United States | Roper Hospital | Charleston | South Carolina |
United States | Resurrection Healthcare | Chicago | Illinois |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin |
United States | Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa |
United States | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado |
United States | Columbus CCOP | Columbus | Ohio |
United States | Doctors Hospital | Columbus | Ohio |
United States | Grant Medical Center | Columbus | Ohio |
United States | John B Amos Cancer Center | Columbus | Georgia |
United States | Mount Carmel Health Center West | Columbus | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | Mercy Hospital | Coon Rapids | Minnesota |
United States | Ochsner Health Center-Covington | Covington | Louisiana |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Dayton CCOP | Dayton | Ohio |
United States | Good Samaritan Hospital - Dayton | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Miami Valley Hospital | Dayton | Ohio |
United States | Samaritan North Health Center | Dayton | Ohio |
United States | Halifax Health Medical Center-Centers for Oncology | Daytona Beach | Florida |
United States | Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | Dekalb Medical Center | Decatur | Georgia |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Colorado Cancer Research Program CCOP | Denver | Colorado |
United States | Exempla Saint Joseph Hospital | Denver | Colorado |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado |
United States | Rose Medical Center | Denver | Colorado |
United States | Iowa Lutheran Hospital | Des Moines | Iowa |
United States | Iowa Methodist Medical Center | Des Moines | Iowa |
United States | Iowa Oncology Research Association CCOP | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa |
United States | Mercy Medical Center - Des Moines | Des Moines | Iowa |
United States | Saint John Hospital and Medical Center | Detroit | Michigan |
United States | Cancer Center of Kansas - Dodge City | Dodge City | Kansas |
United States | Wentworth-Douglass Hospital | Dover | New Hampshire |
United States | Essentia Health Cancer Center | Duluth | Minnesota |
United States | Essentia Health Saint Mary's Medical Center | Duluth | Minnesota |
United States | Miller-Dwan Hospital | Duluth | Minnesota |
United States | Greenville Health System Cancer Institute-Easley | Easley | South Carolina |
United States | The Memorial Hospital at Easton | Easton | Maryland |
United States | Marshfield Clinic Cancer Center at Sacred Heart | Eau Claire | Wisconsin |
United States | Fairview-Southdale Hospital | Edina | Minnesota |
United States | Cancer Center of Kansas - El Dorado | El Dorado | Kansas |
United States | Elkhart Clinic | Elkhart | Indiana |
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Michiana Hematology Oncology PC-Elkhart | Elkhart | Indiana |
United States | Swedish Medical Center | Englewood | Colorado |
United States | Green Bay Oncology - Escanaba | Escanaba | Michigan |
United States | Eureka Hospital | Eureka | Illinois |
United States | Illinois CancerCare-Eureka | Eureka | Illinois |
United States | Fairbanks Memorial Hospital | Fairbanks | Alaska |
United States | Northbay Cancer Center | Fairfield | California |
United States | Saint Francis Hospital | Federal Way | Washington |
United States | Blanchard Valley Hospital | Findlay | Ohio |
United States | Genesys Regional Medical Center-West Flint Campus | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | McLeod Regional Medical Center | Florence | South Carolina |
United States | Front Range Cancer Specialists | Fort Collins | Colorado |
United States | Poudre Valley Hospital | Fort Collins | Colorado |
United States | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas |
United States | Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio |
United States | Hematology Oncology Associates of Fredericksburg Inc | Fredericksburg | Virginia |
United States | Cancer Care Associates of Fresno Medical Group Inc | Fresno | California |
United States | Unity Hospital | Fridley | Minnesota |
United States | Northeast Georgia Medical Center | Gainesville | Georgia |
United States | Illinois CancerCare Galesburg | Galesburg | Illinois |
United States | Glens Falls Hospital | Glens Falls | New York |
United States | Wayne Memorial Hospital | Goldsboro | North Carolina |
United States | Altru Cancer Center | Grand Forks | North Dakota |
United States | Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado |
United States | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana |
United States | Berdeaux, Donald MD (UIA Investigator) | Great Falls | Montana |
United States | Big Sky Oncology | Great Falls | Montana |
United States | Great Falls Clinic | Great Falls | Montana |
United States | North Colorado Medical Center | Greeley | Colorado |
United States | Green Bay Oncology at Saint Vincent Hospital | Green Bay | Wisconsin |
United States | Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay | Wisconsin |
United States | Saint Mary's Hospital | Green Bay | Wisconsin |
United States | Saint Vincent Hospital | Green Bay | Wisconsin |
United States | Cone Health Cancer Center | Greensboro | North Carolina |
United States | Greenville Health System Cancer Institute-Butternut | Greenville | South Carolina |
United States | Greenville Health System Cancer Institute-Eastside | Greenville | South Carolina |
United States | Greenville Health System Cancer Institute-Faris | Greenville | South Carolina |
United States | Greenville Memorial Hospital | Greenville | South Carolina |
United States | Wayne Hospital | Greenville | Ohio |
United States | Greenwich Hospital | Greenwich | Connecticut |
United States | Self Regional Healthcare | Greenwood | South Carolina |
United States | Cancer Centers of the Carolinas-Greer Medical Oncology | Greer | South Carolina |
United States | Saint Francis Hospital and Medical Center | Hartford | Connecticut |
United States | Ingalls Memorial Hospital | Harvey | Illinois |
United States | Illinois CancerCare-Havana | Havana | Illinois |
United States | Mason District Hospital | Havana | Illinois |
United States | Northern Montana Hospital | Havre | Montana |
United States | Geisinger Medical Center-Cancer Center Hazleton | Hazleton | Pennsylvania |
United States | Saint Peter's Community Hospital | Helena | Montana |
United States | Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | Oncare Hawaii Inc-Kuakini | Honolulu | Hawaii |
United States | Oncare Hawaii Inc-POB II | Honolulu | Hawaii |
United States | Queen's Medical Center | Honolulu | Hawaii |
United States | Straub Clinic and Hospital | Honolulu | Hawaii |
United States | The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii |
United States | University of Hawaii Cancer Center | Honolulu | Hawaii |
United States | Edwards Comprehensive Cancer Center | Huntington | West Virginia |
United States | Hutchinson Area Health Care | Hutchinson | Minnesota |
United States | Cancer Center of Kansas-Independence | Independence | Kansas |
United States | Green Bay Oncology - Iron Mountain | Iron Mountain | Michigan |
United States | Allegiance Health | Jackson | Michigan |
United States | Mayo Clinic in Florida | Jacksonville | Florida |
United States | Castle Medical Center | Kailua | Hawaii |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Glacier Oncology PLLC | Kalispell | Montana |
United States | Kalispell Medical Oncology | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Heartland Hematology and Oncology Associates Incorporated | Kansas City | Missouri |
United States | North Kansas City Hospital | Kansas City | Missouri |
United States | Research Medical Center | Kansas City | Missouri |
United States | Saint Joseph Health Center | Kansas City | Missouri |
United States | Saint Luke's Cancer Institute | Kansas City | Missouri |
United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
United States | Kettering Medical Center | Kettering | Ohio |
United States | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois |
United States | Cancer Center of Kansas-Kingman | Kingman | Kansas |
United States | Wellmont Holston Valley Hospital and Medical Center | Kingsport | Tennessee |
United States | Kinston Medical Specialists PA | Kinston | North Carolina |
United States | EvergreenHealth Medical Center | Kirkland | Washington |
United States | University of Tennessee - Knoxville | Knoxville | Tennessee |
United States | Community Howard Regional Health | Kokomo | Indiana |
United States | Gundersen Lutheran Medical Center | La Crosse | Wisconsin |
United States | Adventist La Grange Memorial Hospital | La Grange | Illinois |
United States | IU Health La Porte Hospital | La Porte | Indiana |
United States | IU Health Arnett Cancer Care | Lafayette | Indiana |
United States | Saint Anthony Hospital | Lakewood | Colorado |
United States | Saint Clare Hospital | Lakewood | Washington |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Sparrow Hospital | Lansing | Michigan |
United States | Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada |
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Gwinnett Medical Center | Lawrenceville | Georgia |
United States | Saint Luke's East - Lee's Summit | Lee's Summit | Missouri |
United States | Cancer Center of Kansas-Liberal | Liberal | Kansas |
United States | Liberty Hospital | Liberty | Missouri |
United States | Liberty Radiation Oncology Center | Liberty | Missouri |
United States | Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue | Hawaii |
United States | Saint Rita's Medical Center | Lima | Ohio |
United States | Nebraska Cancer Research Center | Lincoln | Nebraska |
United States | Saint Mary Mercy Hospital | Livonia | Michigan |
United States | Sky Ridge Medical Center | Lone Tree | Colorado |
United States | Longmont United Hospital | Longmont | Colorado |
United States | Doctors Carrol, Sheth, Raghavan | Louisville | Kentucky |
United States | McKee Medical Center | Loveland | Colorado |
United States | Illinois CancerCare-Macomb | Macomb | Illinois |
United States | Mcdonough District Hospital | Macomb | Illinois |
United States | Dean Hematology and Oncology Clinic | Madison | Wisconsin |
United States | Holy Family Memorial Hospital | Manitowoc | Wisconsin |
United States | Mayo Clinic Health Systems-Mankato | Mankato | Minnesota |
United States | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota |
United States | Saint John's Hospital - Healtheast | Maplewood | Minnesota |
United States | Marietta Memorial Hospital | Marietta | Ohio |
United States | Wellstar Kennestone Hospital | Marietta | Georgia |
United States | Bay Area Medical Center | Marinette | Wisconsin |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Cancer Center of Kansas - McPherson | McPherson | Kansas |
United States | Columbia Saint Mary's Hospital - Ozaukee | Mequon | Wisconsin |
United States | Franciscan Saint Anthony Health-Michigan City | Michigan City | Indiana |
United States | Columbia Saint Mary's Water Tower Medical Commons | Milwaukee | Wisconsin |
United States | Abbott-Northwestern Hospital | Minneapolis | Minnesota |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Minneapolis Veterans Medical Center | Minneapolis | Minnesota |
United States | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin |
United States | Trinity Cancer Care Center | Minot | North Dakota |
United States | Michiana Hematology Oncology PC-Mishawaka | Mishawaka | Indiana |
United States | Saint Joseph Regional Medical Center-Mishawaka | Mishawaka | Indiana |
United States | Community Medical Hospital | Missoula | Montana |
United States | Guardian Oncology and Center for Wellness | Missoula | Montana |
United States | Montana Cancer Specialists | Missoula | Montana |
United States | Saint Patrick Hospital - Community Hospital | Missoula | Montana |
United States | Providence Hospital | Mobile | Alabama |
United States | Garneau, Stewart C MD (UIA Investigator) | Moline | Illinois |
United States | Porubcin, Michael MD (UIA Investigator) | Moline | Illinois |
United States | Sharis, Christine M MD (UIA Investigator) | Moline | Illinois |
United States | Spector, David MD (UIA Investigator) | Moline | Illinois |
United States | Stoffel, Thomas J MD (UIA Investigator) | Moline | Illinois |
United States | Trinity Medical Center | Moline | Illinois |
United States | Holy Family Medical Center | Monmouth | Illinois |
United States | Illinois CancerCare-Monmouth | Monmouth | Illinois |
United States | Louisiana State University Sciences Center- Monroe | Monroe | Louisiana |
United States | McLaren-Macomb | Mount Clemens | Michigan |
United States | Knox Community Hospital | Mount Vernon | Ohio |
United States | Saint Joseph Hospital | Nashua | New Hampshire |
United States | Ochsner Medical Center Jefferson | New Orleans | Louisiana |
United States | Licking Memorial Hospital | Newark | Ohio |
United States | Cancer Center of Kansas - Newton | Newton | Kansas |
United States | Michiana Hematology Oncology PC-Niles | Niles | Michigan |
United States | Bromenn Regional Medical Center | Normal | Illinois |
United States | Community Cancer Center Foundation | Normal | Illinois |
United States | Illinois CancerCare-Community Cancer Center | Normal | Illinois |
United States | Southwest VA Regional Cancer Center | Norton | Virginia |
United States | Green Bay Oncology - Oconto Falls | Oconto Falls | Wisconsin |
United States | Providence - Saint Peter Hospital | Olympia | Washington |
United States | Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska |
United States | Alegent Health Immanuel Medical Center | Omaha | Nebraska |
United States | Creighton University Medical Center | Omaha | Nebraska |
United States | Missouri Valley Cancer Consortium | Omaha | Nebraska |
United States | Saint Joseph Hospital - Orange | Orange | California |
United States | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California |
United States | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois |
United States | Ottawa Regional Hospital and Healthcare Center | Ottawa | Illinois |
United States | Ottumwa Regional Health Center | Ottumwa | Iowa |
United States | Menorah Medical Center | Overland Park | Kansas |
United States | Saint Luke's South Hospital | Overland Park | Kansas |
United States | Feather River Cancer Center | Paradise | California |
United States | Cancer Center of Kansas - Parsons | Parsons | Kansas |
United States | Illinois CancerCare-Pekin | Pekin | Illinois |
United States | Pekin Cancer Treatment Center | Pekin | Illinois |
United States | Pekin Hospital | Pekin | Illinois |
United States | Illinois CancerCare-Peoria | Peoria | Illinois |
United States | Illinois Oncology Research Association CCOP | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
United States | OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC | Peoria | Illinois |
United States | Proctor Hospital | Peoria | Illinois |
United States | Illinois CancerCare-Peru | Peru | Illinois |
United States | Illinois Valley Hospital | Peru | Illinois |
United States | Valley Radiation Oncology | Peru | Illinois |
United States | Pennsylvania Hospital | Philadelphia | Pennsylvania |
United States | Phoenixville Hospital | Phoenixville | Pennsylvania |
United States | Michiana Hematology Oncology PC-Plymouth | Plymouth | Indiana |
United States | Saint Joseph Mercy Oakland | Pontiac | Michigan |
United States | Saint Joseph Mercy Port Huron | Port Huron | Michigan |
United States | Kansas City CCOP | Prairie Village | Kansas |
United States | Cancer Center of Kansas - Pratt | Pratt | Kansas |
United States | Illinois CancerCare-Princeton | Princeton | Illinois |
United States | Perry Memorial Hospital | Princeton | Illinois |
United States | Saint Mary Corwin Medical Center | Pueblo | Colorado |
United States | MultiCare Good Samaritan Hospital | Puyallup | Washington |
United States | Annie Penn Memorial Hospital | Reidsville | North Carolina |
United States | Valley Medical Center | Renton | Washington |
United States | Marshfield Clinic at James Beck Cancer Center | Rhinelander | Wisconsin |
United States | Marshfield Clinic-Rice Lake Center | Rice Lake | Wisconsin |
United States | Reid Hospital and Health Care Services | Richmond | Indiana |
United States | Southern Regional Medical Center | Riverdale | Georgia |
United States | North Memorial Medical Health Center | Robbinsdale | Minnesota |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Cancer Trials Support Unit | Rockville | Maryland |
United States | Harbin Clinic Medical Oncology and Clinical Research | Rome | Georgia |
United States | Sutter Roseville Medical Center | Roseville | California |
United States | Sutter General Hospital | Sacramento | California |
United States | Saint Mary's of Michigan | Saginaw | Michigan |
United States | Coborn Cancer Center at Saint Cloud Hospital | Saint Cloud | Minnesota |
United States | Saint Cloud Hospital | Saint Cloud | Minnesota |
United States | Heartland Regional Medical Center | Saint Joseph | Missouri |
United States | Marie Yeager Cancer Center | Saint Joseph | Michigan |
United States | Saint Joseph Oncology Inc | Saint Joseph | Missouri |
United States | Metro-Minnesota NCI Community Oncology Research Program | Saint Louis Park | Minnesota |
United States | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota |
United States | Regions Hospital | Saint Paul | Minnesota |
United States | United Hospital | Saint Paul | Minnesota |
United States | Cancer Center of Kansas - Salina | Salina | Kansas |
United States | Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia |
United States | Guthrie Medical Group PC-Robert Packer Hospital | Sayre | Pennsylvania |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
United States | Pacific Medical Center-First Hill | Seattle | Washington |
United States | Virginia Mason CCOP | Seattle | Washington |
United States | Virginia Mason Medical Center | Seattle | Washington |
United States | Greenville Health System Cancer Institute-Seneca | Seneca | South Carolina |
United States | Saint Francis Regional Medical Center | Shakopee | Minnesota |
United States | Saint Nicholas Hospital | Sheboygan | Wisconsin |
United States | Welch Cancer Center | Sheridan | Wyoming |
United States | Highland Clinic | Shreveport | Louisiana |
United States | Louisiana State University Health Sciences Center Shreveport | Shreveport | Louisiana |
United States | Mercy Medical Center-Sioux City | Sioux City | Iowa |
United States | Saint Luke's Regional Medical Center | Sioux City | Iowa |
United States | Siouxland Hematology Oncology Associates | Sioux City | Iowa |
United States | Medical X-Ray Center | Sioux Falls | South Dakota |
United States | Sanford Cancer Center-Oncology Clinic | Sioux Falls | South Dakota |
United States | Sanford NCI Community Oncology Research Program of the North Central Plains | Sioux Falls | South Dakota |
United States | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota |
United States | Robert Wood Johnson University Hospital Somerset | Somerville | New Jersey |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | Michiana Hematology Oncology PC-South Bend | South Bend | Indiana |
United States | Northern Indiana Cancer Research Consortium CCOP | South Bend | Indiana |
United States | South Bend Clinic | South Bend | Indiana |
United States | Providence Hospital | Southfield | Michigan |
United States | Greenville Health System Cancer Institute-Spartanburg | Spartanburg | South Carolina |
United States | Illinois CancerCare-Spring Valley | Spring Valley | Illinois |
United States | Saint Margaret's Hospital | Spring Valley | Illinois |
United States | CoxHealth South Hospital | Springfield | Missouri |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Mercy Hospital Springfield | Springfield | Missouri |
United States | Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield | Springfield | Missouri |
United States | Springfield Regional Medical Center | Springfield | Ohio |
United States | Lakeland Hospital | St. Joseph | Michigan |
United States | Geisinger Medical Group | State College | Pennsylvania |
United States | Staten Island University Hospital | Staten Island | New York |
United States | Marshfield Clinic Cancer Care at Saint Michael's Hospital | Stevens Point | Wisconsin |
United States | Lakeview Hospital | Stillwater | Minnesota |
United States | Green Bay Oncology - Sturgeon Bay | Sturgeon Bay | Wisconsin |
United States | MultiCare Allenmore Hospital | Tacoma | Washington |
United States | Multicare Health System | Tacoma | Washington |
United States | Northwest CCOP | Tacoma | Washington |
United States | Saint Joseph Medical Center | Tacoma | Washington |
United States | North Suburban Medical Center | Thornton | Colorado |
United States | Upper Valley Medical Center | Troy | Ohio |
United States | Carle Cancer Center | Urbana | Illinois |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | Maui Memorial Medical Center | Wailuku | Hawaii |
United States | Pacific Cancer Institute of Maui | Wailuku | Hawaii |
United States | Saint John Macomb-Oakland Hospital | Warren | Michigan |
United States | Cancer Center of Kansas - Wellington | Wellington | Kansas |
United States | Chester County Hospital | West Chester | Pennsylvania |
United States | Saint Ann's Hospital | Westerville | Ohio |
United States | Marshfield Clinic - Weston Center | Weston | Wisconsin |
United States | Michiana Hematology Oncology-PC Westville | Westville | Indiana |
United States | Exempla Lutheran Medical Center | Wheat Ridge | Colorado |
United States | Associates In Womens Health | Wichita | Kansas |
United States | Cancer Center of Kansas - Main Office | Wichita | Kansas |
United States | Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas |
United States | Via Christi Regional Medical Center | Wichita | Kansas |
United States | Wichita CCOP | Wichita | Kansas |
United States | Geisinger Wyoming Valley | Wilkes-Barre | Pennsylvania |
United States | Rice Memorial Hospital | Willmar | Minnesota |
United States | Clinton Memorial Hospital | Wilmington | Ohio |
United States | Cancer Center of Kansas - Winfield | Winfield | Kansas |
United States | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin |
United States | Minnesota Oncology and Hematology PA-Woodbury | Woodbury | Minnesota |
United States | Wright-Patterson Medical Center | Wright-Patterson Afb | Ohio |
United States | Greene Memorial Hospital | Xenia | Ohio |
United States | North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington |
United States | Genesis HealthCare System | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Paclitaxel/carboplatin (PC) induced peripheral neuropathy as assessed by EORTC QLQ-CIPN20 | The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale. Generalized linear models (repeated measures analysis of variance [ANOVA] if data are complete) will be used to compare the CIPN between GSH and placebo arms. | Up to 6 courses of therapy | No |
Secondary | Antitumor activity of PC as defined by recurrence-free (for patients without clinical evidence of disease) or progression-free (for patients with clinical evidence of disease) survival | A log-rank test and a Kaplan-Meier curve will be used to compare the recurrence free survival between GSH and placebo arms. | Up to 1 year | No |
Secondary | Association between genetic variations and grade 2+ PCI PN | Logistic regression models will be used to evaluate the association of genetic variations (i.e. SNPs) with the incidence of grade 2+ neuropathy. | Up to 1 year | No |
Secondary | Change in patient reported quality of life as assessed by FACT-O and patient daily-symptom questionnaires over time | Two-sample t-tests and Wilcoxon rank-sum tests will be applied to compare changes of neuropathy as measured by patient symptom log and quality of life as measured by FACT-O from baseline to the end of TAXOL/CBDCA. | Baseline to 1 year | No |
Secondary | Paclitaxel acute pain syndrome incidence and severity between GSH and placebo arms | Descriptive statistics and graphical procedure will be used to describe TAXOL/CBDCA acute pain syndrome incidence/severity between GSH and placebo arms. | Up to 1 year | No |
Secondary | Percentage of patients discontinuing PC chemotherapy secondary to PN | A chi-square test or Fisher's exact test will be used to compare the proportion of patients stopping TAXOL/CBDCA secondary to peripheral neuropathy between GSH and placebo arms. | Up to 1 year | No |
Secondary | Percentage of patients undergoing dose reductions secondary to PCI PN | A chi-square test or Fisher's exact test will be used to compare the proportion of patients requiring chemotherapy dose reductions secondary to TAXOL/CBDCA induced peripheral neuropathy between GSH and placebo arms. | Up to 1 year | No |
Secondary | Percentage of patients with grade 2+ and grade 3+ paclitaxel/carboplatin-induced (PCI) peripheral neuropathy (PN) according to the CTCAE neuropathy scale | A chi-square test or Fisher's exact test will be used to compare the proportion of grade 2+ and grade 3+ chemotherapy induced peripheral neuropathy (CIPN) at any time during or at the end of the TAXOL/CBDCA based chemotherapy between GSH and placebo arms. | Up to 1 year | No |
Secondary | Times to onset of CTCAE grade 2+ and grade 3+ PN | Kaplan-Meier curve and log-rank test will be used to compare time to grade 2+ and grade 3+ CIPN between GSH and placebo arms. | Up to 1 year | No |
Secondary | Toxicity profile of glutathione as assessed by CTCAE v4.0 | Descriptive statistics (frequency and percentage) will be used to describe the toxicity profile of GSH. A Wilcoxon rank-sum test or Fisher's exact test will be applied for comparison of most frequent toxicities between GSH and placebo arms when appropriate. | Up to 1 year after completion of treatment | Yes |
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