Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy
Condition: Head and Neck Cancer; Mucositis; Oral Complications of Radiation Therapy; Pain
MeSH terms: Head and Neck Neoplasms; Mucositis; Stomatitis
Intervention: doxepin hydrochloride; placebo
Intervention description: Oral rinse; Oral rinse
Intervention MeSH terms: Doxepin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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; squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; recurrent verrucous carcinoma of the larynx; squamous cell carcinoma of the larynx; 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; adenoid cystic carcinoma of the oral cavity; mucoepidermoid carcinoma of the oral cavity; verrucous carcinoma of the oral cavity; squamous cell carcinoma of the lip and oral cavity; recurrent basal cell carcinoma of the lip; recurrent squamous cell carcinoma of the lip and oral cavity; basal cell carcinoma of the lip; metastatic squamous neck cancer with occult primary squamous cell carcinoma; recurrent metastatic squamous neck cancer with occult primary; untreated metastatic squamous neck cancer with occult primary; recurrent lymphoepithelioma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; lymphoepithelioma of the nasopharynx; squamous cell carcinoma of the nasopharynx; recurrent lymphoepithelioma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; lymphoepithelioma of the oropharynx; squamous cell carcinoma of the oropharynx; recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity; recurrent inverted papilloma of the paranasal sinus and nasal cavity; recurrent midline lethal granuloma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; esthesioneuroblastoma of the paranasal sinus and nasal cavity; inverted papilloma of the paranasal sinus and nasal cavity; midline lethal granuloma of the paranasal sinus and nasal cavity; squamous cell carcinoma of the paranasal sinus and nasal cavity; high-grade salivary gland mucoepidermoid carcinoma; low-grade salivary gland mucoepidermoid carcinoma; recurrent salivary gland cancer; salivary gland acinic cell tumor; salivary gland adenocarcinoma; salivary gland adenoid cystic carcinoma; salivary gland anaplastic carcinoma; salivary gland malignant mixed cell type tumor; salivary gland poorly differentiated carcinoma; salivary gland squamous cell carcinoma; salivary gland cancer; tongue cancer

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 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.
    

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