Topical Sunscreen in Preventing Skin Rash in Patients Receiving Drugs Such as Erlotinib or Cetuximab for Cancer
- Conditions
- Unspecified Adult Solid Tumor, Protocol SpecificDermatologic Complications
- Interventions
- Drug: sunscreenOther: placebo
- Registration Number
- NCT00362986
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Topical sunscreen may be effective in preventing skin rash caused by treatment with drugs such as erlotinib or cetuximab. It is not yet known whether topical sunscreen is more effective than a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer.
PURPOSE: This randomized phase III trial is studying topical sunscreen to see how well it works compared with a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer.
- Detailed Description
OBJECTIVES:
* Compare the incidence and severity of erlotinib-, cetuximab-, or other epidermal growth factor receptor inhibitor-induced skin rash development in patients with cancer treated with prophylactic topical sunscreen vs placebo.
* Determine the toxicity of topical sunscreen vs placebo in these patients.
* Determine whether discontinuation of treatment intervention is followed by rash development.
OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled study. Patients are stratified according to chemotherapy regimen (first-line chemotherapy vs other), epidermal growth factor receptor (EGFR) inhibitor therapy (small molecule vs monoclonal antibodies), concurrent medication that increases sun hypersensitivity (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients apply sunscreen generously to the entire body twice daily for 4 weeks.
* Arm I: Patients apply placebo generously to the entire body twice daily for 4 weeks.
Patients complete self-reported questionnaires regarding their rash status at baseline and then weekly for 8 weeks.
After completion of study treatment, patients are followed for 8 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sunscreen sunscreen Patients apply sunscreen generously to the entire body twice daily for 4 weeks. Patients complete self-reported questionnaires regarding their rash status at baseline and then weekly for 8 weeks. After completion of study treatment, patients are followed for 8 weeks. placebo placebo Patients apply placebo generously to the entire body twice daily for 4 weeks. Patients complete self-reported questionnaires regarding their rash status at baseline and then weekly for 8 weeks. After completion of study treatment, patients are followed for 8 weeks.
- Primary Outcome Measures
Name Time Method Incidence and severity of rash development by Skindex questionnaire Up to 8 weeks
- Secondary Outcome Measures
Name Time Method Toxicity by NCI CTCAE v3.0 Up to 8 weeks Rash incidence at 4 and 8 weeks Up to 8 weeks
Trial Locations
- Locations (205)
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Miller-Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
🇺🇸Robbinsdale, Minnesota, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Firelands Regional Medical Center
🇺🇸Sandusky, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Saint Francis Cancer Center
🇺🇸Shakopee, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Meeker County Memorial Hospital
🇺🇸Lichfield, Minnesota, United States
St. Joseph's Hospital
🇺🇸St Paul, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸Woodbury, Minnesota, United States
MeritCare Broadway
🇺🇸Fargo, North Dakota, United States
MeritCare Clinic - Bemidji
🇺🇸Bemidji, Minnesota, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Foote Hospital
🇺🇸Jackson, Michigan, United States
St. Mary's - Duluth Clinic Cancer Center
🇺🇸Duluth, Minnesota, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Park Nicollet Health Services
🇺🇸St. Louis Park, Minnesota, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
🇺🇸Lambertville, Michigan, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
🇺🇸St. Joseph, Michigan, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
United Hospital
🇺🇸St. Paul, Minnesota, United States
Woodwinds Health Campus
🇺🇸Woodbury, Minnesota, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Medcenter One Hospital Cancer Care Center
🇺🇸Bismarck, North Dakota, United States
Missouri Baptist Cancer Center
🇺🇸St. Louis, Missouri, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Immanuel St. Joseph's Clinic
🇺🇸Mankato, Minnesota, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Minnesota Oncology Hematology, PA - Maplewood
🇺🇸Maplewood, Minnesota, United States
Arch Medical Services, Incorporated at Center for Cancer Care and Research
🇺🇸Saint Louis, Missouri, United States
Regions Hospital Cancer Care Center
🇺🇸St. Paul, Minnesota, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Grant Medical Center Cancer Care
🇺🇸Columbus, Ohio, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Mid Dakota Clinic, PC
🇺🇸Bismarck, North Dakota, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
St. Alexius Medical Center Cancer Center
🇺🇸Bismarck, North Dakota, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
AnMed Cancer Center
🇺🇸Anderson, South Carolina, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
🇺🇸Westerville, Ohio, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
Mercy Medical Center
🇺🇸Springfield, Ohio, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Geisinger Medical Group - Scenery Park
🇺🇸State College, Pennsylvania, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Hematology-Oncology Associates of Fredericksburg, Incorporated
🇺🇸Fredericksburg, Virginia, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
St. Anthony's Memorial Hospital
🇺🇸Effingham, Illinois, United States
Trinity Medical Center - East
🇺🇸Moline, Illinois, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Reid Hospital & Health Care Services, Incorporated
🇺🇸Richmond, Indiana, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
Howard Community Hospital at Howard Regional Health System
🇺🇸Kokomo, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
🇺🇸Mason City, Iowa, United States
McCreery Cancer Center at Ottumwa Regional
🇺🇸Ottumwa, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸West Des Moines, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Fremont Memorial Hospital
🇺🇸Fremont, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Green Bay Oncology, Limited - Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls
🇺🇸Oconto Falls, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Mercy Memorial Hospital - Monroe
🇺🇸Monroe, Michigan, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
Green Bay Oncology, Limited - Escanaba
🇺🇸Escanaba, Michigan, United States
Dickinson County Healthcare System
🇺🇸Iron Mountain, Michigan, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Mercy Capitol 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
John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, 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
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Seton Cancer Institute - Saginaw
🇺🇸Saginaw, Michigan, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States