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
