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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive care, TreatmentClosed18 and overNCI, OtherNCCTG-N09C6
NCI-2011-02049, CDR0000675520, U10CA037404, N09C6, NCT01156142

Trial Description


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.

Further Study Information

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 1 of 2 treatment arms.

  • 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.

Eligibility Criteria

Inclusion Criteria:

1. ≥ 18 years of age

2. 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.

3. ≥ 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.

4. Ability to complete questionnaire(s) independently or with assistance

5. ECOG Performance Status 0, 1 or 2.

6. Provide informed written consent.

7. Willingness to return to enrolling institution for follow-up.

Exclusion Criteria:

1. Known allergy to doxepin, tricyclic antidepressants, or any known component of the drug formulation

2. Use of a tricyclic antidepressant or monoamine oxidase inhibitor within the 2 weeks prior to registration

3. Current untreated or unresolved oral candidiasis or oral HSV infection

4. Current untreated narrow angle glaucoma

5. Current untreated urinary retention ≤ 6 weeks prior to registration

6. 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

7. 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Alliance for Clinical Trials in Oncology

National Cancer Institute

Robert C. MillerStudy Chair

Trial Sites

 Kapiolani Medical Center at Pali Momi
 William S. Loui Ph: 808-586-2979
 Cancer Research Center of Hawaii
 William S. Loui Ph: 808-586-2979
 Hawaii Medical Center - East
 William S. Loui Ph: 808-586-2979
 Kapiolani Medical Center for Women and Children
 William S. Loui Ph: 808-586-2979
 OnCare Hawaii, Incorporated - Kuakini
 William S. Loui Ph: 808-586-2979
 OnCare Hawaii, Incorporated - Lusitana
 William S. Loui Ph: 808-586-2979
 Queen's Cancer Institute at Queen's Medical Center
 William S. Loui Ph: 808-586-2979
 Straub Clinic and Hospital, Incorporated
 William S. Loui Ph: 808-586-2979
 Tripler Army Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
 Castle Medical Center
 William S. Loui Ph: 808-586-2979
 Kauai Medical Clinic
 William S. Loui Ph: 808-586-2979
 Maui Memorial Medical Center
 William S. Loui Ph: 808-586-2979
 Pacific Cancer Institute - Maui
 William S. Loui Ph: 808-586-2979
 Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
 Costas L. Constantinou Ph: 319-363-2690
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 317-783-8918
 Reid Hospital & Health Care Services
 Howard M. Gross Ph: 317-783-8918
  Mason City
 Mercy Cancer Center at Mercy Medical Center - North Iowa
 Arvind Y Vemula Ph: 800-433-3883
 South Iowa Radiation Oncology Center at Ottumwa Regional Health Center
 Robert J Behrens Ph: 888-244-6061
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-3456
 Medini, Eitan MD (UIA Investigator)
 Donald J Jurgens Ph: 877-229-4907
 Immanuel St. Joseph's
 Mohmmad J Ranginwala Ph: 507-385-2929
  Saint Cloud
 Coborn Cancer Center
 Donald J Jurgens Ph: 877-229-4907
 Central Care Cancer Center at Carrie J. Babb Cancer Center
 Robert L Carolla Ph: 417-269-4520
North Carolina
 Rutherford Hospital
 James Dewitt Bearden Ph: 800-486-5941
North Dakota
 Bismarck Cancer Center
 Edward J. Wos Ph: 701-323-5760
 CCOP - Dayton
 Howard M. Gross Ph: 317-783-8918
 David L. Rike Cancer Center at Miami Valley Hospital
 Howard M. Gross Ph: 317-783-8918
 Good Samaritan Hospital
 Howard M. Gross Ph: 317-783-8918
 Grandview Hospital
 Howard M. Gross Ph: 317-783-8918
 Samaritan North Cancer Care Center
 Howard M. Gross Ph: 317-783-8918
 Blanchard Valley Regional Cancer Center
 Howard M. Gross Ph: 317-783-8918
 Atrium Medical Center
 Howard M. Gross Ph: 317-783-8918
 Wayne Hospital
 Howard M. Gross Ph: 317-783-8918
 Charles F. Kettering Memorial Hospital
 Howard M. Gross Ph: 317-783-8918
 UVMC Cancer Care Center at Upper Valley Medical Center
 Howard M. Gross Ph: 317-783-8918
 Ruth G. McMillan Cancer Center at Greene Memorial Hospital
 Howard M. Gross Ph: 317-783-8918
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Suresh G. Nair Ph: 610-402-2273
South Carolina
 AnMed Cancer Center
 James Dewitt Bearden Ph: 800-486-5941
 James Dewitt Bearden Ph: 800-486-5941
 CCOP - Upstate Carolina
 James Dewitt Bearden Ph: 800-486-5941
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 James Dewitt Bearden Ph: 800-486-5941
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Richard C Tenglin Ph: 605-716-3982
  Sioux Falls
 Avera Cancer Institute
 Addison R Tolentino Ph: 800-657-4377

Link to the current record.
NLM Identifer NCT01156142 processed this data on February 27, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to

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