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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

NCT02062632 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-10-01

Study results available
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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.

Conditions

  • 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

Interventions

DRUG

Doxepin Hydrochloride

Given orally

OTHER

Placebo

Given orally

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Terence Sio · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-14
Primary Completion
2015-05-29
Completion
2017-11-06

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02062632 on ClinicalTrials.gov