Active Clinical Trials

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

By April 24, 2017 No Comments

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)

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

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