Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy

Completed · Phase 3 · Has a placebo group

Conditions studied: Head and Neck Cancer, Mucositis, Oral Complications of Radiation Therapy, Pain

In brief

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.

Key facts

Study ID

NCT01156142

Run by

Alliance for Clinical Trials in Oncology

People needed

155

Starts

2010-12-01

Expected to finish

2015-03-02

Last updated by the study team

2017-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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.

You may not qualify if…

• 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

Where it is running

• Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center — Hartford, Connecticut, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• MBCCOP - Medical College of Georgia Cancer Center — Augusta, Georgia, United States
• Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center — Boise, Idaho, United States
• CCOP - Carle Cancer Center — Urbana, Illinois, United States
• Elkhart Clinic, LLC — Elkhart, Indiana, United States
• Michiana Hematology-Oncology, PC - Elkhart — Elkhart, Indiana, United States
• Elkhart General Hospital — Elkhart, Indiana, United States
• Howard Community Hospital — Kokomo, Indiana, United States
• Center for Cancer Therapy at LaPorte Hospital and Health Services — La Porte, Indiana, United States
• Indiana University Health La Porte Hospital — La Porte, Indiana, United States
• Michiana Hematology-Oncology, PC - South Bend — Mishawaka, Indiana, United States
• Saint Joseph Regional Medical Center — Mishawaka, Indiana, United States
• Michiana Hematology Oncology PC-Mishawaka — Mishawaka, Indiana, United States
• Michiana Hematology Oncology PC - Plymouth — Plymouth, Indiana, United States
• CCOP - Northern Indiana CR Consortium — South Bend, Indiana, United States
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• Michiana Hematology Oncology PC - La Porte — Westville, Indiana, United States
• McFarland Clinic, PC — Ames, Iowa, United States
• Cedar Rapids Oncology Associates — Cedar Rapids, Iowa, United States
• Mercy Regional Cancer Center at Mercy Medical Center — Cedar Rapids, Iowa, United States
• Boston University Cancer Research Center — Boston, Massachusetts, United States
• Hickman Cancer Center at Bixby Medical Center — Adrian, Michigan, United States
• Saint Joseph Mercy Cancer Center — Ann Arbor, Michigan, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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