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Topical Doxepin for Radiation-induced Dermatitis

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Doxepin cream 5%
Placebo
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Isfahan University of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

doxepin cream

Placebo

Arm Description

Patients use doxepin cream 5% twice daily for two weeks

Patients use cream without doxepin ingredient twice daily for two weeks

Outcomes

Primary Outcome Measures

Grading of dermatitis was performed according to the Radiation Therapy Oncology Group acute radiation morbidity scoring criteria
at the beginning of 5th week of radiotherapy and use it for two weeks

Secondary Outcome Measures

Full Information

First Posted
May 14, 2015
Last Updated
January 15, 2019
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02447211
Brief Title
Topical Doxepin for Radiation-induced Dermatitis
Official Title
Topical Doxepin for Prevention and Management of Radiation-induced Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
doxepin cream
Arm Type
Active Comparator
Arm Description
Patients use doxepin cream 5% twice daily for two weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients use cream without doxepin ingredient twice daily for two weeks
Intervention Type
Drug
Intervention Name(s)
Doxepin cream 5%
Intervention Description
Patients use doxepin creamtwice daily for one weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patients use cream without doxepin ingredient twice daily for one weeks
Primary Outcome Measure Information:
Title
Grading of dermatitis was performed according to the Radiation Therapy Oncology Group acute radiation morbidity scoring criteria
Description
at the beginning of 5th week of radiotherapy and use it for two weeks
Time Frame
At the beginning of 5th week of radiotherapy to two weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Golnaz Vaseghi, Ph.D
Phone
0989133259802
Email
golnazvaseghi@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alireza Amouheidari, MD
Email
amouheidari@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Golnaz Vaseghi, Ph.D
Organizational Affiliation
Applied Physiology Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alireza Amouheidari, MD
Organizational Affiliation
Head, Department of Radiation Oncology,Isfahan Milad Hospital, Isfahan,Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laleh Shariati, Ph.D
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shaghayegh Shaghayegh Haghjoo-Javanmard, Ph.D
Organizational Affiliation
Applied Physiology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hajar Naji, M.S
Organizational Affiliation
Applied Physiology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
Official's Role
Study Chair
Facility Information:
Facility Name
Isfahan University of Medical Sciences
City
Isfahan
ZIP/Postal Code
81745-319
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Golnaz Vaseghi, Ph.D
Email
golnazvaseghi@yahoo.com
First Name & Middle Initial & Last Name & Degree
Alireza Amouheidari, MD
Email
amouheidari@yahoo.com

12. IPD Sharing Statement

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Topical Doxepin for Radiation-induced Dermatitis

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