Status:
COMPLETED
Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Mucositis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
OUTLINE: This is a multicenter study. Patients are stratified according to gender, concurrent radiosensitizing chemotherapy (yes vs no), and age (\< 60 years vs ≥ 60 years). Patients are randomized to...
Eligibility Criteria
Inclusion
- ≥ 18 years of age
- Histologic proof of malignancy currently undergoing a course of RT (with or without chemotherapy) to a dose of ≥ 5000 cGy using 1.60 to 2.20 Gy per fraction. Note: At least one third of the oral cavity mucosa must be included in the radiation therapy fields.
- ≥ 4 oral pain felt to be related to mucositis for which the patient wants relief as measured by the Numeric Measure of Oral Pain. Note: An oral exam confirming the presence of mucositis should be performed by the enrolling clinician in addition to patient feedback.
- Ability to complete questionnaire(s) independently or with assistance
- ECOG Performance Status 0, 1 or 2.
- Provide informed written consent.
- Willingness to return to enrolling institution for follow-up.
Exclusion
- Known allergy to doxepin, tricyclic antidepressants, or any known component of the drug formulation
- Use of a tricyclic antidepressant or monoamine oxidase inhibitor within the 2 weeks prior to registration
- Current untreated or unresolved oral candidiasis or oral HSV infection
- Current untreated narrow angle glaucoma
- Current untreated urinary retention ≤ 6 weeks prior to registration
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Any of the following because this study involves a study agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2015
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT01156142
Start Date
December 1 2010
End Date
March 2 2015
Last Update
August 9 2017
Active Locations (120)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
3
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
4
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912