DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Topical Doxepin for Radiation-induced Dermatitis

Information source: Isfahan University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Doxepin cream 5% (Drug); Placebo (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: Isfahan University of Medical Sciences

Official(s) and/or principal investigator(s):
Golnaz Vaseghi, Ph.D, Principal Investigator, Affiliation: Applied Physiology Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
Alireza Amouheidari, MD, Principal Investigator, Affiliation: Head, Department of Radiation Oncology,Isfahan Milad Hospital, Isfahan,Iran
Azadeh Eshraghi, Ph.D, Principal Investigator, Affiliation: Department of Pharmacology and Toxicology, Faculty of Pharmacy-International Campus, Iran University of Medical Sciences, Tehran, Iran
Shaghayegh Shaghayegh Haghjoo-Javanmard, Ph.D, Study Director, Affiliation: Applied Physiology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
Hajar Naji, M.S, Study Chair, Affiliation: Applied Physiology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
Pegah Taheri, M.D, Study Chair, Affiliation: Applied Physiology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

Overall contact:
Golnaz Vaseghi, Ph.D, Phone: 0989133259802, Email: golnazvaseghi@yahoo.com

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.

Clinical Details

Official title: Topical Doxepin for Prevention and Management of Radiation-induced Dermatitis

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Grading of dermatitis was performed according to the Radiation Therapy Oncology Group acute radiation morbidity scoring criteria

Detailed description: The patients who have undergone breast surgery and require radiotherapy and fulfill the inclusion criteria of the study will be entered the study. All the patients will be treated

by 3D conformal radiation therapy using CT - based treatment planning and multi leaf linear

accelerators. The patients will be treated by conventional fractionation regimens to a total dose of 5000 cGy (25 fractions of 200 cGy, 5 days per week). Every week the patients will be visited by an experienced radiation oncologist and the skin reaction will be determined and recorded according to RTOG Acute Radiation Morbidity Scoring Criteria which scores from 0 to 4. The patients receive Doxepin cream at the beginning of 5th week of radiotherapy and use it for a whole week. After acquiring written permission, the radiotherapy site will be photographed at the start and ending of the Doxepin

Eligibility

Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Female with a diagnosis of, breast adenocarcinoma and be referred for post-operative

radiotherapy with or without concurrent chemotherapy and with or without mastectomy

- Participants must not be pregnant.

- Participants treated with a total dose of 5000 cGy (25 fractions of 200 cGy, 5 days

per week Exclusion Criteria:

- Patients who are not eligible

- The presence of skin diseases in the radiation area

- Patients have constipation, xerostomia, blurred vision, urinary retention

- Hypersensitivity to doxepin

Locations and Contacts

Golnaz Vaseghi, Ph.D, Phone: 0989133259802, Email: golnazvaseghi@yahoo.com

Isfahan University of Medical Sciences, Isfahan 81745-319, Iran, Islamic Republic of; Recruiting
Golnaz Vaseghi, Ph.D, Email: golnazvaseghi@yahoo.com
Alireza Amouheidari, MD, Email: amouheidari@yahoo.com
Additional Information

Starting date: May 2015
Last updated: May 17, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017