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Topical Doxepin for Radiation-induced Dermatitis

NCT02447211 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-01-16

No results posted yet for this study

Summary

Radiation dermatitis is one of the most common side effects of radiotherapy approximately occurring in about 95% of patients receiving radiotherapy . Acute injury due to structural tissue damage, generation of free radicals, irreversible double-stranded breaks in nuclear and mitochondrial DNA, and initiation of an inflammatory response in the epidermis and dermis occurs within hours to weeks after radiation exposure. Radiation dermatitis due to pain and discomfort has an adverse impact on the quality of a patient's life.The radiation toxicities such as radiation dermatitis encountered in clinical practice are typically managed with a variety of topical agents such as water-based moisturizing creams or lotions, topical steroids, antiinflammatory emulsions, and wound dressings. Pharmacologic interventions for the prevention and treatment of these toxicity can be used to protect skin against radiation damage.Currently, there is no standard treatment for the prevention of radiation-induced dermatitis with demonstrated effectiveness.The aim of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of topical doxepin for the prevention and management of radiation-induced dermatitis during postoperative radiotherapy for breast cancer.

Conditions

Interventions

DRUG

Doxepin cream 5%

Patients use doxepin creamtwice daily for one weeks

OTHER

Placebo

Patients use cream without doxepin ingredient twice daily for one weeks

Sponsors & Collaborators

  • Isfahan University of Medical Sciences

    lead OTHER

Principal Investigators

  • Golnaz Vaseghi, Ph.D · Applied Physiology Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran

  • Alireza Amouheidari, MD · Head, Department of Radiation Oncology,Isfahan Milad Hospital, Isfahan,Iran

  • Laleh Shariati, Ph.D · Isfahan University of Medical Sciences

  • Shaghayegh Shaghayegh Haghjoo-Javanmard, Ph.D · Applied Physiology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

  • Hajar Naji, M.S · Applied Physiology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

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 NCT02447211 on ClinicalTrials.gov