Breast Cancer Clinical Trial
Official title:
Phase III Randomized Double-Blind Study of Mometasone Furoate Versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy
RATIONALE: Steroid therapy, such as mometasone furoate, may prevent radiation dermatitis
caused by radiation therapy. It is not yet known whether mometasone furoate is more
effective than a placebo in preventing radiation dermatitis.
PURPOSE: This randomized phase III trial is studying mometasone furoate to see how well it
works compared to a placebo in preventing radiation dermatitis in patients undergoing
radiation therapy to the breast or chest wall for invasive breast cancer or ductal carcinoma
in situ.
Status | Completed |
Enrollment | 176 |
Est. completion date | June 2014 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of primary invasive breast cancer or ductal carcinoma in situ - Planning to undergo = 5 weeks of continuous definitive or adjuvant external-beam radiotherapy to 1 of the following sites: - Whole breast (as part of breast-conservation therapy) - Chest wall (as part of post-mastectomy irradiation) - Treatment of regional lymph nodes (i.e., axillary, supraclavicular, or internal mammary) allowed - Must meet the following criteria for planned radiotherapy: - Planned total radiation dose = 5,000 Gy and daily radiation dose between 1.75 and 2.12 Gy - No planned split-course radiotherapy - No partial breast treatment, defined as treatment of < 75% of the breast parenchyma - Intensity-modulated radiotherapy planning and delivery, conventional radiotherapy, or 3-dimensional radiotherapy techniques allowed - Must be entered on study within 7 days prior to beginning radiotherapy - Must start study drug prior to receiving the third radiotherapy fraction - No preexisting skin breakdown within the planned radiotherapy field at the time of study entry - No bilateral breast cancer treatment - No inflammatory carcinoma of the breast - Hormone receptor status not specified PATIENT CHARACTERISTICS: - Male or female - Menopausal status not specified - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to complete questionnaires independently or with assistance - No known allergy or hypersensitivity to mometasone furoate (Elocon® or generic cream), imidazolidinyl urea, or formaldehyde PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior radiotherapy to the planned radiotherapy treatment area - No concurrent or planned leukotriene inhibitors, including the following: - Zafirleukast - Monteleukast - Zileuton - No concurrent or planned use of any prescription or over-the-counter medications containing hydrocortisone or any other cortisone or steroid-containing preparations (systemic, local, or topical) including, but not limited to, the following creams or ointments: - Cortaid® - Cortizone 10® - Tucks® - Preparation H® - No other concurrent topical agents (e.g., lotions, aloe vera) to radiotherapy field during study treatment |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan |
United States | McFarland Clinic, PC | Ames | Iowa |
United States | AnMed Cancer Center | Anderson | South Carolina |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan |
United States | Rush-Copley Cancer Care Center | Aurora | Illinois |
United States | Mary Rutan Hospital | Bellefontaine | Ohio |
United States | MeritCare Bemidji | Bemidji | Minnesota |
United States | Billings Clinic - Downtown | Billings | Montana |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana |
United States | Northern Rockies Radiation Oncology Center | Billings | Montana |
United States | St. Vincent Healthcare Cancer Care Services | Billings | Montana |
United States | Bismarck Cancer Center | Bismarck | North Dakota |
United States | Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota |
United States | Mid Dakota Clinic, PC | Bismarck | North Dakota |
United States | St. Alexius Medical Center Cancer Center | Bismarck | North Dakota |
United States | St. Joseph Medical Center | Bloomington | Illinois |
United States | Wood County Oncology Center | Bowling Green | Ohio |
United States | Bozeman Deaconess Cancer Center | Bozeman | Montana |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | St. James Healthcare Cancer Care | Butte | Montana |
United States | Graham Hospital | Canton | Illinois |
United States | Memorial Hospital | Carthage | Illinois |
United States | Cedar Rapids Oncology Associates | Cedar Rapids | Iowa |
United States | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Doctors Hospital at Ohio Health | Columbus | Ohio |
United States | Grant Medical Center Cancer Care | Columbus | Ohio |
United States | Mount Carmel Health - West Hospital | Columbus | Ohio |
United States | Riverside Methodist Hospital Cancer Care | Columbus | Ohio |
United States | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | CCOP - Iowa Oncology Research Association | Des Moines | Iowa |
United States | John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa |
United States | John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa |
United States | Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa |
United States | Mercy Capitol Hospital | Des Moines | Iowa |
United States | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota |
United States | Miller - Dwan Medical Center | Duluth | Minnesota |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas |
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Eureka Community Hospital | Eureka | Illinois |
United States | CCOP - MeritCare Hospital | Fargo | North Dakota |
United States | MeritCare Broadway | Fargo | North Dakota |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia |
United States | Fremont Memorial Hospital | Fremont | Ohio |
United States | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota |
United States | Galesburg Clinic, PC | Galesburg | Illinois |
United States | Galesburg Cottage Hospital | Galesburg | Illinois |
United States | InterCommunity Cancer Center of Western Illinois | Galesburg | Illinois |
United States | Big Sky Oncology | Great Falls | Montana |
United States | Great Falls Clinic - Main Facility | Great Falls | Montana |
United States | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan |
United States | Mason District Hospital | Havana | Illinois |
United States | St. Peter's Hospital | Helena | Montana |
United States | Hopedale Medical Complex | Hopedale | Illinois |
United States | Hutchinson Area Health Care | Hutchinson | Minnesota |
United States | Foote Hospital | Jackson | Michigan |
United States | Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois |
United States | Glacier Oncology, PLLC | Kalispell | Montana |
United States | Kalispell Medical Oncology at KRMC | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Kewanee Hospital | Kewanee | Illinois |
United States | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas |
United States | Howard Community Hospital | Kokomo | Indiana |
United States | Franciscan Skemp Healthcare - La Crosse Campus | La Crosse | Wisconsin |
United States | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana |
United States | Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville | Michigan |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | Southwest Medical Center | Liberal | Kansas |
United States | Meeker County Memorial Hospital | Lichfield | Minnesota |
United States | Lima Memorial Hospital | Lima | Ohio |
United States | Cancer Resource Center - Lincoln | Lincoln | Nebraska |
United States | McDonough District Hospital | Macomb | Illinois |
United States | Immanuel St. Joseph's | Mankato | Minnesota |
United States | HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota |
United States | Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota |
United States | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio |
United States | Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin |
United States | Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City | Iowa |
United States | Northwest Ohio Oncology Center | Maumee | Ohio |
United States | St. Luke's Hospital | Maumee | Ohio |
United States | Saint Anthony Memorial Health Centers | Michigan City | Indiana |
United States | Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota |
United States | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota |
United States | Community Medical Center | Missoula | Montana |
United States | Guardian Oncology and Center for Wellness | Missoula | Montana |
United States | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana |
United States | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana |
United States | Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline | Illinois |
United States | Community Cancer Center of Monroe | Monroe | Michigan |
United States | Mercy Memorial Hospital - Monroe | Monroe | Michigan |
United States | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio |
United States | Cancer Center of Kansas, PA - Newton | Newton | Kansas |
United States | BroMenn Regional Medical Center | Normal | Illinois |
United States | Community Cancer Center | Normal | Illinois |
United States | St. Charles Mercy Hospital | Oregon | Ohio |
United States | Toledo Clinic - Oregon | Oregon | Ohio |
United States | Community Hospital of Ottawa | Ottawa | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois |
United States | McCreery Cancer Center at Ottumwa Regional | Ottumwa | Iowa |
United States | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas |
United States | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois |
United States | CCOP - Illinois Oncology Research Association | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois |
United States | OSF St. Francis Medical Center | Peoria | Illinois |
United States | Proctor Hospital | Peoria | Illinois |
United States | Illinois Valley Community Hospital | Peru | Illinois |
United States | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas |
United States | Perry Memorial Hospital | Princeton | Illinois |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Rutherford Hospital | Rutherfordton | North Carolina |
United States | Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan |
United States | Coborn Cancer Center | Saint Cloud | Minnesota |
United States | Arch Medical Services, Incorporated at Center for Cancer Care and Research | Saint Louis | Missouri |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | Cancer Center of Kansas, PA - Salina | Salina | Kansas |
United States | Firelands Regional Medical Center | Sandusky | Ohio |
United States | North Coast Cancer Care, Incorporated | Sandusky | Ohio |
United States | St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota |
United States | Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming |
United States | Mercy Medical Center - Sioux City | Sioux City | Iowa |
United States | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa |
United States | St. Luke's Regional Medical Center | Sioux City | Iowa |
United States | Avera Cancer Institute | Sioux Falls | South Dakota |
United States | Medical X-Ray Center, PC | Sioux Falls | South Dakota |
United States | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota |
United States | CCOP - Northern Indiana CR Consortium | South Bend | Indiana |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | Saint Joseph Regional Medical Center | South Bend | Indiana |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | St. Margaret's Hospital | Spring Valley | Illinois |
United States | Valley Cancer Center | Spring Valley | Illinois |
United States | Community Hospital of Springfield and Clark County | Springfield | Ohio |
United States | Mercy Medical Center | Springfield | Ohio |
United States | HealthEast Cancer Care at St. Joseph's Hospital | St Paul | Minnesota |
United States | CentraCare Clinic - River Campus | St. Cloud | Minnesota |
United States | Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph | Michigan |
United States | Missouri Baptist Cancer Center | St. Louis | Missouri |
United States | Park Nicollet Cancer Center | St. Louis Park | Minnesota |
United States | Regions Hospital Cancer Care Center | St. Paul | Minnesota |
United States | United Hospital | St. Paul | Minnesota |
United States | Flower Hospital Cancer Center | Sylvania | Ohio |
United States | Mercy Hospital of Tiffin | Tiffin | Ohio |
United States | CCOP - Toledo Community Hospital | Toledo | Ohio |
United States | Medical University of Ohio Cancer Center | Toledo | Ohio |
United States | St. Vincent Mercy Medical Center | Toledo | Ohio |
United States | Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio |
United States | Toledo Hospital | Toledo | Ohio |
United States | LaFortune Cancer Center at St. John Medical Center | Tulsa | Oklahoma |
United States | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma |
United States | Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | St. John Macomb Hospital | Warren | Michigan |
United States | Fulton County Health Center | Wauseon | Ohio |
United States | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas |
United States | Mount Carmel St. Ann's Cancer Center | Westerville | Ohio |
United States | Associates in Womens Health, PA - North Review | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas |
United States | Wesley Medical Center | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas |
United States | HealthEast Cancer Care at Woodwinds Health Campus | Woodbury | Minnesota |
United States | Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota |
United States | Genesis - Good Samaritan Hospital | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
North Central Cancer Treatment Group | National Cancer Institute (NCI) |
United States,
Atherton PJ, Burger KN, Loprinzi CL, Neben Wittich MA, Miller RC, Jatoi A, Sloan JA. Using the Skindex-16 and Common Terminology Criteria for Adverse Events to assess rash symptoms: results of a pooled-analysis (N0993). Support Care Cancer. 2012 Aug;20(8):1729-35. doi: 10.1007/s00520-011-1266-x. Epub 2011 Sep 16. — View Citation
Miller RC, Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Stoffel TJ, Haselow RE, Schaefer PL, Bearden JD 3rd, Atherton PJ, Loprinzi CL, Martenson JA. Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiother — View Citation
Neben-Wittich MA, Atherton PJ, Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Loprinzi CL, Burger KN, Martenson JA, Miller RC. Comparison of provider-assessed and patient-reported outcome measures of acute skin toxicity during a Phase III trial — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Maximum Grade of Radiation Dermatitis by Treatment Arm. | Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE). | During Radiation Treatment, up to a maximum of 9 weeks. | No |
Secondary | Incidence of Severe ( Grade >=3) Radiation Dermatitis | To compare incidence of severe (Grade = 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. | During Radiation Treatment, up to a maximum of 9 weeks. | No |
Secondary | Skin Toxicity as Measured by the Skin Toxicity Assessment Tool | Mean of the Maximum Patient Reported Skin Toxicity Assessment Tool (STAT) per patient on a 0 to 5 scale during radiation treatment. Lower scores indicate less toxicity. | During Radiation Treatment, up to a maximum of 9 weeks. | No |
Secondary | Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16). | Patient-Reported Mean of the Maximum Total a Skindex-16 Toxicity Score per patient on a 0-6 scale during radiation treatment (Lower score indicates less toxicity). | During Radiation Treatment, up to a maximum of 11 weeks. | No |
Secondary | Duration of Severe (Grade = 3) Radiation Dermatitis as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. This Analysis Was Not Completed Due to Too Little Incidence of the Dermatitis. | To compare time to onset and duration of severe (Grade = 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. This analysis was not completed due to too little incidence of the dermatitis. | During Radiation Treatment, up to a maximum of 9 weeks. | No |
Secondary | Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA) | Patient completed QOL assessment was the Linear Analogue Self-Assessment (LASA). This instrument consisted of 6 questions with responses ranging from 0 (poor QOL) to 100 (best QOL). | During Radiation Treatment, up to a maximum of 11 weeks. | No |
Secondary | QOL Domains as Measured by LASA | Mean scores of Linear Analogue Sef-Assessment (LASA) Mental, physical, emotional, social, spiritual wel-being on a 0 (as bad as it can be) to 100 (as good as it can be) scale. | During Radiation Treatment, up to a maximum of 11 weeks. | No |
Secondary | Adverse Events Assessed Clinically by NCI CTCAE v3.0 | During Radiation Treatment, up to a maximum of 9 weeks. | No | |
Secondary | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). | Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better) | During Radiation Treatment, up to a maximum of 11 weeks. | No |
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