RATIONALE: Doxepin hydrochloride may be an effective treatment for oral mucositis pain in
patients undergoing radiation therapy with or without chemotherapy.
PURPOSE: This randomized phase III trial is studying doxepin hydrochloride to see how well
it works compared to placebo in treating oral mucositis pain in patients with head and neck
cancer undergoing radiation therapy with or without chemotherapy.
- Arm I: Patients receive doxepin hydrochloride oral rinse (swish, gargle, and spit)*
over 1 minute on day 1. Patients may crossover to arm II on day 2.
- Arm II: Patients receive placebo oral rinse (swish, gargle, and spit)* over 1 minute on
day 1.
Patients may crossover to arm I on day 2. The primary and secondary objectives are detailed
below.
Primary Objective:
Determine whether doxepin oral rinse is effective in reducing OM-related pain in patients
undergoing RT to the oral cavity, as measured by a patient-reported questionnaire at 5,15,
30, 60, 120 and 240 minutes
Secondary Objectives:
1. Assess the adverse event profile of doxepin rinse using a patient-reported
questionnaire at 5, 15, 30, 60, 120 and 240 minutes for domains of unpleasant taste,
burning or stinging discomfort, and drowsiness.
2. Compare the incidence of using alternative analgesics before 4 hours, between the
doxepin oral rinse and placebo arms.
3. Assess patient preference for continued therapy with oral rinse after initial test
rinse or after the cross-over phase.
NOTE: * Patients are instructed to avoid taking medications for mucositis pain 60 minutes
before and after study medication.
After completing study therapy, patients have the option to receive doxepin hydrochloride
oral rinse every 4 hours as needed during radiotherapy.
Patients complete questionnaires at baseline, and at 5, 15, 30, 60, 120, and 240 minutes
after study medication. Patients who choose to continue doxepin hydrochloride oral rinse
also complete weekly questionnaires.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Mayo Clinic Scottsdale, Scottsdale, Arizona 85259-5499, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut 06105, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida 32224, United States
MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia 30912, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center, Boise, Idaho 83706, United States
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
Elkhart Clinic, LLC, Elkhart, Indiana 46514-2098, United States
Elkhart General Hospital, Elkhart, Indiana 46515, United States
Michiana Hematology-Oncology, PC - Elkhart, Elkhart, Indiana 46514, United States
Howard Community Hospital, Kokomo, Indiana 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana 46350, United States
Indiana University Health La Porte Hospital, La Porte, Indiana 46350, United States
Michiana Hematology Oncology PC-Mishawaka, Mishawaka, Indiana 46545, United States
Michiana Hematology-Oncology, PC - South Bend, Mishawaka, Indiana 46545-1470, United States
Saint Joseph Regional Medical Center, Mishawaka, Indiana 46545-1470, United States
Michiana Hematology Oncology PC - Plymouth, Plymouth, Indiana 46563, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States
Memorial Hospital of South Bend, South Bend, Indiana 46601, United States
Michiana Hematology Oncology PC - La Porte, Westville, Indiana 46391, United States
McFarland Clinic, PC, Ames, Iowa 50010, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa 52403, United States
Mercy Regional Cancer Center at Mercy Medical Center, Cedar Rapids, Iowa 52403, United States
Boston University Cancer Research Center, Boston, Massachusetts 02118, United States
Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan 49221, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan 48106-0995, United States
Battle Creek Health System Cancer Care Center, Battle Creek, Michigan 49017, United States
Mecosta County Medical Center, Big Rapids, Michigan 49307, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan 48123-2500, United States
Saint John Hospital and Medical Center, Detroit, Michigan 48236, United States
Genesys Hurley Cancer Institute, Flint, Michigan 48503, United States
Hurley Medical Center, Flint, Michigan 48503, United States
Genesys Regional Medical Center, Grand Blanc, Michigan 48439, United States
Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan 49503, United States
CCOP - Grand Rapids, Grand Rapids, Michigan 49503, United States
Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan 49503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan 48236, United States
Allegiance Health, Jackson, Michigan 49201, United States
Foote Memorial Hospital, Jackson, Michigan 49201, United States
Sparrow Regional Cancer Center, Lansing, Michigan 48912-1811, United States
St. Mary Mercy Hospital, Livonia, Michigan 48154, United States
Community Cancer Center of Monroe, Monroe, Michigan 48162, United States
Mercy Memorial Hospital - Monroe, Monroe, Michigan 48162, United States
Mercy General Health Partners, Muskegon, Michigan 49444, United States
St. Joseph Mercy Oakland, Pontiac, Michigan 48341-2985, United States
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan 48601, United States
Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan 49085, United States
Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan 49085, United States
Marie Yeager Cancer Center, Saint Joseph, Michigan 49085, United States
Munson Medical Center, Traverse City, Michigan 49684, United States
St. John Macomb Hospital, Warren, Michigan 48093, United States
MeritCare Bemidji, Bemidji, Minnesota 56601, United States
Sanford Clinic North-Bemidgi, Bemidji, Minnesota 56601, United States
Fairview Ridges Hospital, Burnsville, Minnesota 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota 55433, United States
Fairview Southdale Hospital, Edina, Minnesota 55435, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota 55432, United States
Hutchinson Area Health Care, Hutchinson, Minnesota 55350, United States
HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota 55109, United States
Minnesota Oncology - Maplewood, Maplewood, Minnesota 55109, United States
Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota 55415, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota 55407, United States
New Ulm Medical Center, New Ulm, Minnesota 56073, United States
Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota 55422-2900, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States
Park Nicollet Cancer Center, Saint Louis Park, Minnesota 55416, United States
United Hospital, Saint Paul, Minnesota 55102, United States
St. Francis Cancer Center at St. Francis Medical Center, Shakopee, Minnesota 55379, United States
Regions Hospital Cancer Care Center, St. Paul, Minnesota 55101, United States
Lakeview Hospital, Stillwater, Minnesota 55082, United States
Ridgeview Medical Center, Waconia, Minnesota 55387, United States
Willmar Cancer Center at Rice Memorial Hospital, Willmar, Minnesota 56201, United States
Minnesota Oncology - Woodbury, Woodbury, Minnesota 55125, United States
Cancer Resource Center - Lincoln, Lincoln, Nebraska 68510, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center, Omaha, Nebraska 68124, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States
Creighton University Medical Center, Omaha, Nebraska 68131-2197, United States
Immanuel Medical Center, Omaha, Nebraska 68122, United States
Lakeside Hospital, Omaha, Nebraska 68130, United States
CCOP - MeritCare Hospital, Fargo, North Dakota 58122, United States
MeritCare Broadway, Fargo, North Dakota 58102, United States
Roger Maris Cancer Center at MeritCare Hospital, Fargo, North Dakota 58122, United States
Sanford Clinic North-Fargo, Fargo, North Dakota 58102, United States
Sanford Medical Center-Fargo, Fargo, North Dakota 58122, United States
Altru Cancer Center at Altru Hospital, Grand Forks, North Dakota 58201, United States
Wood County Oncology Center, Bowling Green, Ohio 43402, United States
Community Cancer Center, Elyria, Ohio 44035, United States
Hematology Oncology Center, Elyria, Ohio 44035, United States
Lima Memorial Hospital, Lima, Ohio 45804, United States
Northwest Ohio Oncology Center, Maumee, Ohio 43537-1839, United States
St. Charles Mercy Hospital, Oregon, Ohio 43616, United States
Toledo Clinic - Oregon, Oregon, Ohio 43616, United States
Flower Hospital Cancer Center, Sylvania, Ohio 43560, United States
Mercy Hospital of Tiffin, Tiffin, Ohio 44883, United States
CCOP - Toledo Community Hospital, Toledo, Ohio 43617, United States
Medical University of Ohio Cancer Center, Toledo, Ohio 43614, United States
St. Anne Mercy Hospital, Toledo, Ohio 43623, United States
St. Vincent Mercy Medical Center, Toledo, Ohio 43608, United States
Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio 43623, United States
Toledo Hospital, Toledo, Ohio 43606, United States
Fulton County Health Center, Wauseon, Ohio 43567, United States
Fredericksburg Oncology, Incorporated, Fredericksburg, Virginia 22401, United States
Marshfield Clinic - Chippewa Center, Chippewa Falls, Wisconsin 54729, United States
Center for Cancer Treatment & Prevention at Sacred Heart Hospital, Eau Claire, Wisconsin 54701, United States
Marshfield Clinic Cancer Care at Regional Cancer Center, Eau Claire, Wisconsin 54701, United States
Marshfield Clinic - Ladysmith Center, Ladysmith, Wisconsin 54848, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States
Saint Joseph's Hospital, Marshfield, Wisconsin 54449, United States
Marshfield Clinic - Lakeland Center, Minocqua, Wisconsin 54548, United States
Ministry Medical Group at Saint Mary's Hospital, Rhinelander, Wisconsin 54501, United States
Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin 54868, United States
Marshfield Clinic at Saint Michael's Hospital, Stevens Point, Wisconsin 54481, United States
Saint Michael's Hospital Cancer Center, Stevens Point, Wisconsin 54481, United States
Marshfield Clinic - Wausau Center, Wausau, Wisconsin 54401, United States
Diagnostic and Treatment Center, Weston, Wisconsin 54476, United States
Marshfield Clinic - Weston Center, Weston, Wisconsin 54476, United States
Ministry Saint Clare's Hospital, Weston, Wisconsin 54476, United States
Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin 54494, United States