Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy
Condition: Esophageal Carcinoma; Hypopharyngeal Carcinoma; Laryngeal Carcinoma; Lymphoma; Mesothelioma; Metastatic Malignant Neoplasm in the Lung; Metastatic Malignant Neoplasm in the Pleura; Metastatic Malignant Neoplasm in the Spinal Cord; Non-Small Cell Lung Carcinoma; Sarcoma; Small Cell Lung Carcinoma; Thymic Carcinoma; Thymoma; Thyroid Gland Carcinoma
MeSH terms: Carcinoma; Neoplasms; Mesothelioma; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasms, Second Primary; Esophageal Neoplasms; Thymoma; Small Cell Lung Carcinoma; Thyroid Neoplasms
Intervention: Doxepin Hydrochloride; Placebo; Quality-of-Life Assessment; Questionnaire Administration
Intervention description: Given orally; Given orally; Ancillary studies; Ancillary studies
Intervention MeSH terms: Doxepin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized pilot clinical trial studies the effects of taking doxepin hydrochloride as
      compared to placebo (inactive drug) in treating esophageal pain in patients with cancer
      located in the chest area receiving radiation therapy to the thorax with or without
      chemotherapy. Doxepin hydrochloride is a tricyclic antidepressant drug which was recently
      shown to be helpful for mouth pain in patients receiving radiation therapy. Doxepin
      hydrochloride affects the surface of the esophagus, which may be helpful in reducing the pain
      caused by radiation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological confirmation of thoracic malignancies including non-small cell lung
             cancer (NSCLC), small lung cancer (SCLC), esophageal cancer, hypopharyngeal and
             laryngeal cancers (for which esophagitis symptoms can be relieved by doxepin swallow),
             lymphoma, thyroid, thymoma, thymic carcinoma, mesothelioma, sarcoma, and spinal,
             pulmonary or pleural-based metastases

          -  Planned RT (with or without chemotherapy) to a dose of >= 20 Gray (Gy) using 1.60 Gy
             per daily fraction; if radiation is given twice daily, a cumulative planned dose of >=
             15 Gy using at least 1.25 Gy per fraction is required; hypofractionated and
             stereotactic body radiation therapy regimen are allowed

          -  At least 5 cm of the esophagus must be planned to receive radiotherapy, with a minimum
             dose of at least 10 Gy

          -  >= 3 esophageal pain, either at rest or during swallowing, felt to be related to
             esophagitis for which the patient wants relief, as measured by asking the following
             question

               -  ?On a scale of 0 to 10 (0 = no pain; 10 = worst pain), what number best describes
                  your chest pain* (right now) due to your radiation treatment??

                    -  Radiation can cause inflammation in your esophagus which can feel like a
                       chest pain, either at rest or during swallowing

          -  Able to swallow the study medication

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

          -  Negative pregnancy test done =< 28 days prior to registration, for women of
             childbearing potential only

          -  Ability to complete questionnaire(s) by themselves or with assistance

          -  Provide informed written consent

          -  Willingness to complete evaluation and questionnaires per protocol at the
             participating institution for follow-up (during the active monitoring phase of the
             study)

        Exclusion Criteria:

          -  Known allergy to doxepin, tricyclic antidepressants, or any known component of the
             drug formulation

          -  Histologic proof of and getting treatment for esophageal, stomach, spinal cord,
             thyroid, breast, and head and neck cancers and vertebral metastases

          -  Use of a tricyclic antidepressant or monoamine oxidase inhibitor within the 2 weeks
             prior to registration

          -  The presence or strong clinical suspicion of a tracheoesophageal fistula, or known
             esophageal invasion by cancer

          -  Current untreated or unresolved esophageal candidiasis or herpes simplex virus (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

               -  Pregnant women

               -  Nursing women

          -  Current use of doxepin or doxepin rinse as a swallow preparation