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

This study is currently recruiting participants.
Verified July 2013 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier:
NCT01156142
First received: July 1, 2010
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Mucositis
Oral Complications of Radiation Therapy
Pain
Drug: doxepin hydrochloride
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized Double-Blind Study of Doxepin Rinse Versus Placebo in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Total pain reduction (mouth and throat) [ Time Frame: Baseline and Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total taste of the oral rinse as measured by the numerical analogue scale of taste of the oral rinse in the questionnaires [ Time Frame: Up to 9 days ] [ Designated as safety issue: No ]
  • Total stinging or burning from the oral rinse [ Time Frame: Up to 9 days ] [ Designated as safety issue: No ]
  • Total drowsiness increase [ Time Frame: Up to 9 days ] [ Designated as safety issue: No ]
  • Incidence of using alternative analgesics 4 hours before and in between study medications [ Time Frame: Up to 9 days ] [ Designated as safety issue: No ]
  • Patient preference for continuing therapy with oral doxepin hydrochloride [ Time Frame: Up to 9 days ] [ Designated as safety issue: No ]
  • Pain reduction and other adverse event profile in the optional blinded cross-over phase [ Time Frame: Up to 9 days ] [ Designated as safety issue: Yes ]
  • Long-term outcome of doxepin hydrochloride oral rinse as measured by weekly questionnaire responses [ Time Frame: Up to 9 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 198
Study Start Date: December 2010
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: doxepin hydrochloride
Oral rinse
Placebo Comparator: 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.
Other: placebo
Oral rinse

Detailed Description:

OBJECTIVES:

Primary

  • Determine whether doxepin hydrochloride mouth rinse, compared to placebo, is effective in reducing oral mucositis-related pain in patients with head and neck cancer undergoing radiotherapy with or without chemotherapy.

Secondary

  • Assess the adverse event profile of these regimens, using a patient-reported questionnaire at 5, 15, 30, 60, 120, and 240 minutes, in these patients.
  • Compare the incidence of using alternative analgesics 4 hours before and in between these regimens in these patients.
  • Assess patient preference for continuing therapy with oral doxepin hydrochloride after initial test rinse or after optional cross-over phase.

Tertiary

  • Assess pain reduction and other adverse event profile in patients who cross-over to the optional blinded phase using the same patient-reported questionnaire.
  • Assess pain reduction and other adverse event profile in patients who continue to receive optional oral doxepin hydrochloride.

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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed head and neck cancer meeting the following criteria:

    • Undergoing radiotherapy with or without chemotherapy

      • At least 1/3 of the oral cavity mucosa must be included in the radiotherapy field
  • Oral pain related to mucositis of ≥ grade 4 and for which the patient wants relief as measured by patient response to a pain scale question rating (0 to 10)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • No known allergy to doxepin hydrochloride, tricyclic antidepressants, or any known component of the drug formulation
  • No untreated or unresolved oral candidiasis or oral herpes simplex virus infection
  • No untreated narrow-angle glaucoma
  • No untreated urinary retention in the past 6 weeks
  • No co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study, or interfere significantly with proper assessment of safety and toxicity of the prescribed regimens
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 2 weeks since prior tricyclic antidepressant or monoamine oxidase inhibitor
  • No viscous lidocaine, 'magic mouthwash', benzocaine, diphenhydramine, or other medicated oral rinse within 4 hours before or after the study medication

    • Normal saline or baking soda rinse allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156142

  Show 120 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Robert C. Miller, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier: NCT01156142     History of Changes
Other Study ID Numbers: NCCTG-N09C6, NCI-2011-02049, CDR0000675520
Study First Received: July 1, 2010
Last Updated: July 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
oral complications of radiation therapy
mucositis
pain
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage I squamous cell carcinoma of the larynx
stage I verrucous carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage II verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
recurrent adenoid cystic carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent verrucous carcinoma of the oral cavity
stage I adenoid cystic carcinoma of the oral cavity
stage I mucoepidermoid carcinoma of the oral cavity
stage I verrucous carcinoma of the oral cavity
stage II adenoid cystic carcinoma of the oral cavity
stage II mucoepidermoid carcinoma of the oral cavity
stage II verrucous carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity

Additional relevant MeSH terms:
Head and Neck Neoplasms
Stomatitis
Mucositis
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Doxepin
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014