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Topical Doxepin for Radiation-induced Dermatitis

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ClinicalTrials.gov Identifier: NCT02447211
Recruitment Status : Recruiting
First Posted : May 18, 2015
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Golnaz Vaseghi, Isfahan University of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Doxepin cream 5% Other: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Topical Doxepin for Prevention and Management of Radiation-induced Dermatitis
Study Start Date : May 2015
Actual Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: doxepin cream
Patients use doxepin cream 5% twice daily for two weeks
Drug: Doxepin cream 5%
Patients use doxepin creamtwice daily for one weeks

Placebo Comparator: Placebo
Patients use cream without doxepin ingredient twice daily for two weeks
Other: Placebo
Patients use cream without doxepin ingredient twice daily for one weeks




Primary Outcome Measures :
  1. Grading of dermatitis was performed according to the Radiation Therapy Oncology Group acute radiation morbidity scoring criteria [ Time Frame: At the beginning of 5th week of radiotherapy to two weeks ]
    at the beginning of 5th week of radiotherapy and use it for two weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02447211


Contacts
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Contact: Golnaz Vaseghi, Ph.D 0989133259802 golnazvaseghi@yahoo.com
Contact: Alireza Amouheidari, MD amouheidari@yahoo.com

Locations
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Iran, Islamic Republic of
Isfahan University of Medical Sciences Recruiting
Isfahan, Iran, Islamic Republic of, 81745-319
Contact: Golnaz Vaseghi, Ph.D       golnazvaseghi@yahoo.com   
Contact: Alireza Amouheidari, MD       amouheidari@yahoo.com   
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Principal Investigator: Golnaz Vaseghi, Ph.D Applied Physiology Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
Principal Investigator: Alireza Amouheidari, MD Head, Department of Radiation Oncology,Isfahan Milad Hospital, Isfahan,Iran
Principal Investigator: Laleh Shariati, Ph.D Isfahan University of Medical Sciences
Study Director: Shaghayegh Shaghayegh Haghjoo-Javanmard, Ph.D Applied Physiology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
Study Chair: Hajar Naji, M.S Applied Physiology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

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Responsible Party: Golnaz Vaseghi, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02447211    
Other Study ID Numbers: 900
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Dermatitis
Radiodermatitis
Skin Diseases
Radiation Injuries
Wounds and Injuries
Doxepin
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action