Clinical trial: Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy (NCT02062632)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea.  The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease.  He smokes 2 packs of cigarettes daily for the past 30 years.  On examination, there are decreased breath sounds and percussive dullness at the base of the left lung.  Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli.

Patient description (patient's own words): I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli.

Does the patient match the trial criteria? Entailment