Status:
COMPLETED
Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Oral Mucositis Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 preparation...
Detailed Description
Patients are stratified according to sex (male vs. female), concurrent use of chemotherapy (no vs. yes), patient age at registration (\< 60 years old vs. ≥ 60 years old and RTOG acute radiation morbid...
Eligibility Criteria
Inclusion
- 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).
- 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.
- 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.
- Ability to complete questionnaire(s) by themselves or with assistance.
- 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.
- 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.
- No current diagnosed untreated or unresolved oral candidiasis or oral HSV infection.
- No history of untreated narrow angle glaucoma within 6 weeks prior to registration.
- No untreated urinary retention within 6 weeks prior to registration.
- No current use of glutamine or sucralfate powders at the time of registration (no washout required).
- No cryotherapy for prophylactic mucosal protection within 6 weeks prior to registration.
- 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.
- Age ≥ 18 years
- ECOG Performance Status 0, 1, or 2
Exclusion
Key Trial Info
Start Date :
November 18 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2019
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT02229539
Start Date
November 18 2014
End Date
March 15 2019
Last Update
May 18 2025
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