NCT02447211

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

3.7 years

First QC Date

May 14, 2015

Last Update Submit

January 15, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    At the beginning of 5th week of radiotherapy to two weeks

Study Arms (2)

doxepin cream

ACTIVE COMPARATOR

Patients use doxepin cream 5% twice daily for two weeks

Drug: Doxepin cream 5%

Placebo

PLACEBO COMPARATOR

Patients use cream without doxepin ingredient twice daily for two weeks

Other: Placebo

Interventions

Doxepin cream 5%DRUG

Patients use doxepin creamtwice daily for one weeks

doxepin cream
PlaceboOTHER

Patients use cream without doxepin ingredient twice daily for one weeks

Placebo

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan University of Medical Sciences

Isfahan, 81745-319, Iran

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Shaghayegh Shaghayegh Haghjoo-Javanmard, Ph.D

    Applied Physiology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

    STUDY DIRECTOR

  • Hajar Naji, M.S

    Applied Physiology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

    STUDY CHAIR

Central Study Contacts

Golnaz Vaseghi, Ph.D

CONTACT

0989133259802golnazvaseghi@yahoo.com

Alireza Amouheidari, MD

CONTACT

amouheidari@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Isfahan University of Medical Sciences

Study Record Dates

First Submitted

May 14, 2015

First Posted

May 18, 2015

Study Start

May 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations

IR(1)