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Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy

Estimated reading time: 1 min

Condition

Esophageal Carcinoma|Hypopharyngeal Carcinoma|Laryngeal Carcinoma|Lymphoma|Malignant Mesothelioma|Malignant Pleural Effusion|Metastatic Malignant Neoplasm in the Spinal Cord|Non-Small Cell Lung Carcinoma|Sarcoma|Small Cell Lung Carcinoma|Thymic Carcinoma|Thymoma|Thyroid Gland Carcinoma

Estimated Enrollment: 50

Age Group: 18 Years and older   (Adult, Senior)

Gender: All

Study Type: Interventional

Study Design Allocation: Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Double Blind (Participant, Investigator)|Primary Purpose: Supportive Care

Study ID Numbers: MC13C1|NCI-2014-00253|P30CA015083

Study First Received: February 12, 2014

Last Updated: December 20, 2016

Estimated Primary Completion Date: October 2017

Primary Outcome Measures:

Change in mouth pain using a 0 to 10 numerical analogue scale for mouth pain|Adverse event rates using CTCAE, RTOG and PRO|Change in mouth pain using crossover analysis|Incidence of drowsiness|Incidence of grade 3 or higher adverse events as measured by CTCAE and RTOG adverse event grade scales, and patient-reported outcomes (PRO)|Incidence of stinging or burning|Incidence of unpleasant taste|Maximum reported CTCAE grade|Use of alternative analgesics

Sponsors and Collaborators:

Mayo Clinic|National Cancer Institute (NCI)

Result Received: No Study Results Posted

Website Link: https://ClinicalTrials.gov/show/NCT02062632

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