Acute Oral Mucositis Pain Clinical Trial
Official title:
A Phase III Placebo-Controlled, Randomized Three-Arm Study of Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
| Verified date | October 2019 |
| Source | Alliance for Clinical Trials in Oncology |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.
| Status | Completed |
| Enrollment | 275 |
| Est. completion date | March 15, 2019 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
1. Documentation of Disease: Histologic documentation of malignancy currently undergoing
a course of RT (with or without chemotherapy) including the oral cavity and/or
oropharyngeal area to a dose of at least 4500 cGy using more than 5 fractions (i.e.,
stereotactic body radiation therapy [SBRT] is not allowed). 2. Physical exam demonstrating evidence of radiotherapy-related mucositis in the visible oral cavity and/or oropharynx consistent with mucous membrane toxicity greater than 0 using the Acute Radiation Morbidity Scoring Criteria. 3. At least 4 (out of 10) patient-reported oral pain related to oral mucositis secondary to RT for which the patient seeks relief, as measured on the Oral Pain Assessment. Note: The pain score must be at least 4 at the time that the patient starts the first dose of study medication. The patient may be enrolled to the study if s/he, at times, has a pain score of at least 4, so long as initiation of study treatment begins when the pain score is at least 4. 4. Ability to complete questionnaire(s) by themselves or with assistance. 5. No known allergy to diphenhydramine, lidocaine, antacid (aluminum hydroxide, magnesium hydroxide, and simethicone), doxepin, tricyclic antidepressants, or any known component of the drug formulation in the testing arms. 6. No use of any anti-arrhythmic medication (except for beta-blockers) including lidocaine, linezolid, ipratropium, or medications with high anti-cholinergic potency (including neostigmine, a tricyclic antidepressant or a monoamine oxidase inhibitor) within 2 weeks prior to registration. 7. No current diagnosed untreated or unresolved oral candidiasis or oral HSV infection. 8. No history of untreated narrow angle glaucoma within 6 weeks prior to registration. 9. No untreated urinary retention within 6 weeks prior to registration. 10. No current use of glutamine or sucralfate powders at the time of registration (no washout required). 11. No cryotherapy for prophylactic mucosal protection within 6 weeks prior to registration. 12. Not pregnant, because patients eligible for this study will be receiving radiotherapy, which has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done = 28 days prior to registration is required. 13. Age = 18 years 14. ECOG Performance Status 0, 1, or 2 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Avera Saint Luke's Hospital and Cancer Center | Aberdeen | South Dakota |
| United States | Providence Regional Cancer System-Aberdeen | Aberdeen | Washington |
| United States | Cancer Care Center at Island Hospital | Anacortes | Washington |
| United States | Alaska Breast Care and Surgery LLC | Anchorage | Alaska |
| United States | Alaska Oncology and Hematology LLC | Anchorage | Alaska |
| United States | Alaska Regional Hospital | Anchorage | Alaska |
| United States | Alaska Women's Cancer Care | Anchorage | Alaska |
| United States | Anchorage Oncology Centre | Anchorage | Alaska |
| United States | Anchorage Radiation Therapy Center | Anchorage | Alaska |
| United States | Katmai Oncology Group | Anchorage | Alaska |
| United States | Providence Alaska Medical Center | Anchorage | Alaska |
| United States | AnMed Health Cancer Center | Anderson | South Carolina |
| United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
| United States | Randolph Hospital | Asheboro | North Carolina |
| United States | Rocky Mountain Cancer Centers-Aurora | Aurora | Colorado |
| United States | The Medical Center of Aurora | Aurora | Colorado |
| United States | Bronson Battle Creek | Battle Creek | Michigan |
| United States | Beaufort Memorial Hospital | Beaufort | South Carolina |
| United States | Swedish Cancer Institute-Eastside Oncology Hematology | Bellevue | Washington |
| United States | PeaceHealth Saint Joseph Medical Center | Bellingham | Washington |
| United States | Sanford Clinic North-Bemidji | Bemidji | Minnesota |
| United States | Saint Charles Health System | Bend | Oregon |
| United States | Constantinou, Costas L MD (UIA Investigator) | Bettendorf | Iowa |
| 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 | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho |
| United States | Saint Luke's Mountain States Tumor Institute | Boise | Idaho |
| United States | Central Care Center - Carrie J. Babb Cancer Center | Bolivar | Missouri |
| United States | Parkland Health Center-Bonne Terre | Bonne Terre | Missouri |
| United States | Boulder Community Hospital | Boulder | Colorado |
| United States | Rocky Mountain Cancer Centers-Boulder | Boulder | Colorado |
| United States | Cox Cancer Center Branson | Branson | Missouri |
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | Veterans Affairs Western New York Health Care System-Buffalo | Buffalo | New York |
| United States | Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California |
| United States | Fairview Ridges Hospital | Burnsville | Minnesota |
| United States | Illinois CancerCare - Canton | Canton | Illinois |
| United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
| United States | Southeast Cancer Center | Cape Girardeau | Missouri |
| United States | Memorial Hospital of Carbondale | Carbondale | Illinois |
| United States | Mercy Hospital | Cedar Rapids | Iowa |
| United States | Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa |
| United States | Centralia Oncology Clinic | Centralia | Illinois |
| United States | Providence Regional Cancer System-Centralia | Centralia | Washington |
| United States | Cancer Center of Kansas - Chanute | Chanute | Kansas |
| United States | Carolina Surgical Clinic of Charlotte PA | Charlotte | North Carolina |
| United States | Novant Health Presbyterian Medical Center | Charlotte | North Carolina |
| United States | Oncology Specialists of Charlotte | Charlotte | North Carolina |
| United States | Southern Oncology Specialists-Charlotte | Charlotte | North Carolina |
| United States | Martha Jefferson Hospital | Charlottesville | Virginia |
| United States | Cheyenne Regional Medical Center-West | Cheyenne | Wyoming |
| United States | Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin |
| United States | Clackamas Radiation Oncology Center | Clackamas | Oregon |
| United States | Providence Oncology and Hematology Care Southeast | Clackamas | Oregon |
| United States | Morton Plant Hospital | Clearwater | Florida |
| United States | Southeastern Medical Oncology Center-Clinton | Clinton | North Carolina |
| United States | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado |
| United States | Rocky Mountain Cancer Centers-Penrose | Colorado Springs | Colorado |
| United States | Mercy Hospital | Coon Rapids | Minnesota |
| United States | Bay Area Hospital | Coos Bay | Oregon |
| United States | Geisinger Medical Center | Danville | Pennsylvania |
| United States | Oakwood Hospital and Medical Center | Dearborn | Michigan |
| United States | Cancer Care Specialists of Central Illinois | Decatur | Illinois |
| United States | Decatur Memorial Hospital | Decatur | Illinois |
| United States | Heartland Cancer Research NCORP | Decatur | Illinois |
| United States | Colorado Blood Cancer Institute | 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 | Rocky Mountain Cancer Centers-Midtown | Denver | Colorado |
| United States | Rocky Mountain Cancer Centers-Rose | 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 | Medical Oncology and Hematology Associates - 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 | Epic Care-Dublin | Dublin | California |
| United States | Mercy Medical Center | Durango | Colorado |
| United States | Southwest Oncology PC | Durango | Colorado |
| United States | Greenville Health System Cancer Institute-Easley | Easley | South Carolina |
| United States | Marshfield Clinic Cancer Center at Sacred Heart | Eau Claire | Wisconsin |
| United States | Sacred Heart Hospital | Eau Claire | Wisconsin |
| United States | Fairview Southdale Hospital | Edina | Minnesota |
| United States | Swedish Medical Center-Edmonds | Edmonds | Washington |
| United States | Crossroads Cancer Center | Effingham | Illinois |
| United States | Cancer Center of Kansas - El Dorado | El Dorado | Kansas |
| United States | Bay Area Breast Surgeons Inc | Emeryville | California |
| United States | Epic Care Partners in Cancer Care | Emeryville | California |
| United States | Comprehensive Cancer Care and Research Institute of Colorado LLC | Englewood | California |
| United States | Swedish Medical Center | Englewood | Colorado |
| United States | Green Bay Oncology - Escanaba | Escanaba | Michigan |
| United States | Illinois CancerCare - Eureka | Eureka | Illinois |
| United States | Providence Regional Cancer Partnership | Everett | Washington |
| United States | Sanford Clinic North-Fargo | Fargo | North Dakota |
| United States | Sanford Medical Center-Fargo | Fargo | North Dakota |
| United States | Sanford Roger Maris Cancer Center | Fargo | North Dakota |
| United States | Genesys Hurley Cancer Institute | Flint | Michigan |
| United States | Hurley Medical Center | Flint | Michigan |
| United States | Saint Agnes Hospital/Agnesian Cancer Center | Fond Du Lac | Wisconsin |
| United States | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas |
| United States | Unity Hospital | Fridley | Minnesota |
| United States | Saint Luke's Mountain States Tumor Institute - Fruitland | Fruitland | Idaho |
| United States | Gibbs Cancer Center-Gaffney | Gaffney | South Carolina |
| United States | Illinois CancerCare - Galesburg | Galesburg | Illinois |
| United States | Western Illinois Cancer Treatment Center | Galesburg | Illinois |
| United States | CaroMont Regional Medical Center | Gastonia | North Carolina |
| United States | Adams Cancer Center | Gettysburg | Pennsylvania |
| United States | Mountain Blue Cancer Care Center | Golden | Colorado |
| United States | Southeastern Medical Oncology Center-Goldsboro | Goldsboro | North Carolina |
| United States | Wayne Memorial Hospital | Goldsboro | North Carolina |
| United States | Altru Cancer Center | Grand Forks | North Dakota |
| United States | Mercy Health Saint Mary's | Grand Rapids | Michigan |
| United States | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan |
| 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-Andrews | 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 | Rocky Mountain Cancer Centers-Greenwood Village | Greenwood Village | Colorado |
| United States | Gibbs Cancer Center-Pelham | Greer | South Carolina |
| United States | Greenville Health System Cancer Institute-Greer | Greer | South Carolina |
| United States | Saint Francis Hospital and Medical Center | Hartford | Connecticut |
| United States | Geisinger Medical Center-Cancer Center Hazelton | Hazleton | Pennsylvania |
| United States | 21st Century Oncology-Henderson | Henderson | Nevada |
| United States | Comprehensive Cancer Centers of Nevada - Henderson | Henderson | Nevada |
| United States | Comprehensive Cancer Centers of Nevada-Southeast Henderson | Henderson | Nevada |
| United States | Las Vegas Cancer Center-Henderson | Henderson | Nevada |
| United States | Hendersonville Hematology and Oncology at Pardee | Hendersonville | North Carolina |
| United States | Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina |
| United States | Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida |
| United States | Lake Norman Hematology Oncology Specialists-Huntersville | Huntersville | North Carolina |
| United States | Lake Norman Hematology Oncology Specialists-Huntersville | Huntersville | North Carolina |
| United States | Southern Oncology Specialists-Huntersville | Huntersville | North Carolina |
| 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 | Swedish Medical Center - Issaquah | Issaquah | Washington |
| United States | Allegiance Health | Jackson | Michigan |
| United States | Southeastern Medical Oncology Center-Jacksonville | Jacksonville | North Carolina |
| United States | Capital Region Medical Center-Goldschmidt Cancer Center | Jefferson City | Missouri |
| United States | Borgess Medical Center | Kalamazoo | Michigan |
| United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
| United States | West Michigan Cancer Center | Kalamazoo | Michigan |
| United States | Novant Health Oncology Specialists-Kernersville | Kernersville | North Carolina |
| United States | Illinois CancerCare - Kewanee Clinic | Kewanee | Illinois |
| United States | Cancer Center of Kansas - Kingman | Kingman | Kansas |
| United States | Mayo Clinic Health System-Franciscan Healthcare | La Crosse | Wisconsin |
| United States | Providence Regional Cancer System-Lacey | Lacey | Washington |
| United States | Rocky Mountain Cancer Centers-Lakewood | Lakewood | Colorado |
| United States | Saint Anthony Hospital | Lakewood | Colorado |
| United States | Sparrow Hospital | Lansing | Michigan |
| United States | 21st Century Oncology | Las Vegas | Nevada |
| United States | 21st Century Oncology-Fort Apache | Las Vegas | Nevada |
| United States | 21st Century Oncology-Vegas Tenaya | Las Vegas | Nevada |
| United States | Cancer and Blood Specialists-Fort Apache | Las Vegas | Nevada |
| United States | Cancer and Blood Specialists-Henderson | Las Vegas | Nevada |
| United States | Cancer and Blood Specialists-Shadow | Las Vegas | Nevada |
| United States | Cancer and Blood Specialists-Tenaya | Las Vegas | Nevada |
| United States | Cancer Therapy and Integrative Medicine | Las Vegas | Nevada |
| United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
| United States | Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas | Nevada |
| United States | Comprehensive Cancer Centers of Nevada - Northwest | Las Vegas | Nevada |
| United States | Comprehensive Cancer Centers of Nevada-Summerlin | Las Vegas | Nevada |
| United States | HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills | Las Vegas | Nevada |
| United States | HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway | Las Vegas | Nevada |
| United States | HealthCare Partners Medical Group Oncology/Hematology-San Martin | Las Vegas | Nevada |
| United States | HealthCare Partners Medical Group Oncology/Hematology-Tenaya | Las Vegas | Nevada |
| United States | Las Vegas Cancer Center-Medical Center | Las Vegas | Nevada |
| United States | Nevada Cancer Research Foundation NCORP | Las Vegas | Nevada |
| United States | Radiation Oncology Centers of Nevada Central | Las Vegas | Nevada |
| United States | Radiation Oncology Centers of Nevada Southeast | Las Vegas | Nevada |
| United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
| United States | Lawrence Memorial Hospital | Lawrence | Kansas |
| United States | Lewistown Hospital | Lewistown | Pennsylvania |
| United States | Novant Health Oncology Specialists-Davidson County | Lexington | North Carolina |
| United States | Cancer Center of Kansas - Liberal | Liberal | Kansas |
| United States | Littleton Adventist Hospital | Littleton | Colorado |
| United States | Rocky Mountain Cancer Centers-Littleton | Littleton | Colorado |
| United States | Saint Mary Mercy Hospital | Livonia | Michigan |
| United States | Rocky Mountain Cancer Centers-Sky Ridge | Lone Tree | Colorado |
| United States | Sky Ridge Medical Center | Lone Tree | Colorado |
| United States | Longmont United Hospital | Longmont | Colorado |
| United States | Rocky Mountain Cancer Centers-Longmont | Longmont | Colorado |
| United States | Saint John Medical Center | Longview | Washington |
| United States | McKee Medical Center | Loveland | Colorado |
| United States | Illinois CancerCare - Macomb | Macomb | Illinois |
| United States | Holy Family Memorial Hospital | Manitowoc | Wisconsin |
| United States | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota |
| United States | Saint John's Hospital - Healtheast | Maplewood | Minnesota |
| United States | Bay Area Medical Center | Marinette | Wisconsin |
| United States | Marshfield Clinic | Marshfield | Wisconsin |
| United States | Saint Joseph's Hospital | Marshfield | Wisconsin |
| United States | Contra Costa Regional Medical Center | Martinez | California |
| United States | Matthews Radiation Oncology Center | Matthews | North Carolina |
| United States | Novant Health Cancer Specialists-Matthews | Matthews | North Carolina |
| United States | Saint Luke's Mountain States Tumor Institute - Meridian | Meridian | Idaho |
| United States | Mount Sinai Medical Center | Miami Beach | Florida |
| United States | Middlesex Hospital | Middletown | Connecticut |
| United States | Abbott-Northwestern Hospital | Minneapolis | Minnesota |
| United States | Health Partners Inc | Minneapolis | Minnesota |
| United States | Hennepin County Medical Center | Minneapolis | Minnesota |
| United States | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin |
| United States | Memorial Regional Cancer Center Day Road | Mishawaka | Indiana |
| United States | Garneau, Stewart C MD (UIA Investigator) | Moline | Illinois |
| United States | Spector, David MD (UIA Investigator) | Moline | Illinois |
| United States | Trinity Medical Center | Moline | Illinois |
| United States | Lake Norman Hematology Oncology Specialists-Mooresville | Mooresville | North Carolina |
| United States | Novant Health Oncology Specialists-Mount Airy | Mount Airy | North Carolina |
| United States | Mercy Health Mercy Campus | Muskegon | Michigan |
| United States | Saint Luke's Mountain States Tumor Institute - Nampa | Nampa | Idaho |
| United States | North Shore-LIJ Health System/Center for Advanced Medicine | New Hyde Park | New York |
| United States | Westfields Hospital/Cancer Center of Western Wisconsin | New Richmond | Wisconsin |
| United States | New Ulm Medical Center | New Ulm | Minnesota |
| United States | Providence Newberg Medical Center | Newberg | Oregon |
| United States | Cancer Center of Kansas - Newton | Newton | Kansas |
| United States | Lakeland Community Hospital | Niles | Michigan |
| United States | Alta Bates Summit Medical Center - Summit Campus | Oakland | California |
| United States | Bay Area Tumor Institute CCOP | Oakland | California |
| United States | Hematology and Oncology Associates-Oakland | Oakland | California |
| United States | Green Bay Oncology - Oconto Falls | Oconto Falls | Wisconsin |
| United States | Mercy Hospital Oklahoma City | Oklahoma City | Oklahoma |
| United States | Providence Willamette Falls Medical Center | Oregon City | Oregon |
| United States | Illinois CancerCare- Ottawa Clinic | Ottawa | Illinois |
| United States | Radiation Oncology of Northern Illinois | Ottawa | Illinois |
| United States | Parker Adventist Hospital | Parker | Colorado |
| United States | Rocky Mountain Cancer Centers-Parker | Parker | Colorado |
| 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 | Memorial Hospital West | Pembroke Pines | Florida |
| United States | Illinois CancerCare-Peoria | Peoria | Illinois |
| United States | Methodist Medical Center of Illinois | Peoria | Illinois |
| United States | OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC | Peoria | Illinois |
| United States | OSF St. Francis Medical Center | Peoria | Illinois |
| United States | Illinois CancerCare-Peru | Peru | Illinois |
| United States | Valley Radiation Oncology | Peru | Illinois |
| United States | FirstHealth of the Carolinas-Moore Regional Hospital | Pinehurst | North Carolina |
| United States | Saint Joseph Mercy Oakland | Pontiac | Michigan |
| United States | Saint Joseph Mercy Port Huron | Port Huron | Michigan |
| United States | Maine Medical Center - Bramhall Campus | Portland | Maine |
| United States | Providence Portland Medical Center | Portland | Oregon |
| United States | Providence Saint Vincent Medical Center | Portland | Oregon |
| United States | Geisinger Medical Oncology-Pottsville | Pottsville | Pennsylvania |
| United States | Cancer Center of Kansas - Pratt | Pratt | Kansas |
| United States | Illinois CancerCare-Princeton | Princeton | Illinois |
| United States | Rocky Mountain Cancer Centers - Pueblo | Pueblo | Colorado |
| United States | Saint Mary Corwin Medical Center | Pueblo | Colorado |
| United States | Spectrum Health Reed City Hospital | Reed City | Michigan |
| United States | Annie Penn Memorial Hospital | Reidsville | North Carolina |
| United States | Marshfield Clinic at James Beck Cancer Center | Rhinelander | Wisconsin |
| United States | Marshfield Clinic-Rice Lake Center | Rice Lake | Wisconsin |
| United States | North Memorial Medical Health Center | Robbinsdale | Minnesota |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | OSF Saint Anthony Medical Center | Rockford | Illinois |
| United States | Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri |
| United States | Phelps County Regional Medical Center | Rolla | Missouri |
| United States | William Beaumont Hospital - Royal Oak | Royal Oak | Michigan |
| United States | Saint Mary's of Michigan | Saginaw | Michigan |
| United States | Lakeland Hospital | Saint Joseph | Michigan |
| United States | Marie Yeager Cancer Center | Saint Joseph | Michigan |
| United States | Barnes-Jewish West County Hospital | Saint Louis | Missouri |
| United States | Mercy Hospital Saint Louis | Saint Louis | Missouri |
| United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
| United States | Saint Louis Cancer and Breast Institute - South City | Saint Louis | Missouri |
| United States | Siteman Cancer Center-South County | Saint Louis | Missouri |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| 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 | Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri |
| United States | Cancer Center of Kansas - Salina | Salina | Kansas |
| United States | Carolina Oncology Associates PA | Salisbury | North Carolina |
| United States | Group Health Cooperative-Seattle | Seattle | Washington |
| United States | Minor and James Medical PLLC | Seattle | Washington |
| United States | Pacific Gynecology Specialists | Seattle | Washington |
| United States | Swedish Medical Center-Ballard Campus | Seattle | Washington |
| United States | Swedish Medical Center-First Hill | 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 | Providence Regional Cancer System-Shelton | Shelton | Washington |
| United States | Siouxland Regional Cancer Center | Sioux City | Iowa |
| United States | Avera Cancer Institute | Sioux Falls | South Dakota |
| United States | Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota |
| United States | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota |
| United States | Memorial Hospital of South Bend | South Bend | Indiana |
| United States | Greenville Health System Cancer Institute-Spartanburg | Spartanburg | South Carolina |
| United States | Spartanburg Medical Center | Spartanburg | South Carolina |
| United States | Evergreen Hematology and Oncology PS | Spokane | Washington |
| United States | Rockwood Cancer Treatment Center-DHEC-Downtown | Spokane | Washington |
| United States | Rockwood Clinic Cancer Treatment Center-Valley | Spokane Valley | Washington |
| United States | Cancer Research for the Ozarks NCORP | Springfield | Missouri |
| United States | Central Illinois Hematology Oncology Center | Springfield | Illinois |
| United States | Cox Health South Hospital | Springfield | Missouri |
| United States | Memorial Medical Center | Springfield | Illinois |
| United States | Mercy Hospital Springfield | Springfield | Missouri |
| United States | Springfield Clinic | Springfield | Illinois |
| United States | Geisinger Medical Group | State College | Pennsylvania |
| United States | Novant Health Oncology Specialists-Statesville | Statesville | North Carolina |
| United States | Marshfield Clinic at Saint Michael's Hospital | Stevens Point | Wisconsin |
| United States | Saint Michael's Hospital | Stevens Point | Wisconsin |
| United States | Lakeview Hospital | Stillwater | Minnesota |
| United States | Door County Cancer Center | Sturgeon Bay | Wisconsin |
| United States | Green Bay Oncology - Sturgeon Bay | Sturgeon Bay | Wisconsin |
| United States | Missouri Baptist Sullivan Hospital | Sullivan | Missouri |
| United States | Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri |
| United States | Cancer Care Specialists of Illinois-Swansea | Swansea | Illinois |
| United States | Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida |
| United States | Rocky Mountain Cancer Centers-Thornton | Thornton | Colorado |
| United States | Munson Medical Center | Traverse City | Michigan |
| United States | William Beaumont Hospital - Troy | Troy | Michigan |
| United States | Saint Luke's Mountain States Tumor Institute-Twin Falls | Twin Falls | Idaho |
| United States | PeaceHealth Southwest Medical Center | Vancouver | Washington |
| United States | Ridgeview Medical Center | Waconia | Minnesota |
| United States | Providence Saint Mary Regional Cancer Center | Walla Walla | Washington |
| United States | Saint John Macomb-Oakland Hospital | Warren | Michigan |
| United States | Veterans Affairs Medical Center - Washington, DC | Washington | District of Columbia |
| United States | Marshfield Clinic-Wausau Center | Wausau | Wisconsin |
| United States | Cancer Center of Kansas - Wellington | Wellington | Kansas |
| United States | Methodist West Hospital | West Des Moines | Iowa |
| United States | Diagnostic and Treatment Center | Weston | Wisconsin |
| United States | Marshfield Clinic - Weston Center | Weston | Wisconsin |
| United States | Saint Clare's Hospital | Weston | Wisconsin |
| 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 | Wesley Medical Center | Wichita | Kansas |
| United States | Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania |
| United States | Novant Health Oncology Specialists-Wilkesboro | Wilkesboro | North Carolina |
| United States | Rice Memorial Hospital | Willmar | Minnesota |
| United States | Southeastern Medical Oncology Center-Wilson | Wilson | North Carolina |
| United States | Cancer Center of Kansas - Winfield | Winfield | Kansas |
| United States | Novant Health Forsyth Medical Center | Winston-Salem | North Carolina |
| United States | Novant Health Oncology Specialists | Winston-Salem | North Carolina |
| United States | Winston-Salem Health Care | Winston-Salem | North Carolina |
| United States | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin |
| United States | Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota |
| United States | North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington |
| United States | Providence Regional Cancer System-Yelm | Yelm | Washington |
| United States | WellSpan Health-York Hospital | York | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Area Under the Curve (AUC) of Total Pain Reduction | Total pain reduction (mouth and throat) was measured by the numerical analogue scale of mouth pain on a scale of 0 to 10, with 0=no pain and 10=worst pain in the questionnaires taken at baseline, and 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total pain reduction was calculated by the (average of mouth and throat) area under the curve (AUC) adjusting for baseline, with time scale (baseline, 5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 0, 1, 2, 3, 4, 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing baseline data, or only provided baseline data, he/she was excluded from the statistical analysis. | Baseline, 5, 15, 30, 60, 120, 240 minutes post treatment | |
| Secondary | The Total Unpleasant Taste of the Oral Rinse as Measured by the Numerical Analogue Scale of Taste of the Oral Rinse in the Questionnaires | Up to 4 hours post-treatment | ||
| Secondary | The Total Stinging or Burning From the Oral Rinse as Measured by the Numerical Analogue Scale of Stinging or Burning From the Oral Rinse in the Questionnaires | Up to 4 hours post-treatment | ||
| Secondary | The Total Drowsiness Increase as Measured by the Numerical Analogue Scale of Drowsiness Questionnaires | Up to 4 hours post-treatment every 4 hours while on treatment | ||
| Secondary | The Incidence of Using Alternative Analgesics Between 1 and 4 Hours After Initial Mouthwash | Up to 4 hours post-treatment | ||
| Secondary | Patient Preference for Continued Therapy With Oral Rinse After Initial Test Rinse Phase, as Measured by Item 9 in the Patient-reported Questionnaire After 4 Hours | Up to 4 hours post-treatment | ||
| Secondary | The Length of Time in the Continuation Phase | Up to 4 hours post-treatment | ||
| Secondary | Pain Score in the Continuation Phase | Up to 4 hours post-treatment | ||
| Secondary | Alternative Analgesics Use in the Continuation Phase | Up to 4 hours post-treatment |