Effects of Herbal Products on Reduction of Radiation-induced Dermatitis in Breast Cancer Patients

June 21, 2018 updated by: Saengrawee Thanthong, Chulabhorn Cancer Center
The herbal products on reduction of radiation-induced dermatitis in patients with breast cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To compare the effect of each herb extracts to protect the skin from the adverse effects of radiation therapy in patients with breast cancer with herbal extract products.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10210
        • Chulabhorn Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 20 years old or older,
  • Diagnosed with Breast cancer
  • On course of external Radiation therapy

Exclusion Criteria:

  • Pregnant
  • Previously underwent external Radiation therapy
  • Illiterate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard skin care
standard skin care
Placebo Comparator: Control
Moisture Cream
Other: Control
Apply moisture cream to the treatment skin everyday after radiation therapy
Active Comparator: Cucumber cream
Apply Cucumber cream everyday after radiation therapy on the treatment aria skin.
Other: Cucumber cream
Apply cucumber cream to the treatment skin everyday after radiation therapy
Active Comparator: Centella cream
Apply Centella asiatica cream everyday after radiation therapy on the treatment aria skin.
Other: Centella cream
Apply centella cream to the treatment skin everyday after radiation therapy
Other Names:
  • Centella asiatica
Active Comparator: Thunbergia cream
Apply Thunbergia cream everyday after radiation therapy on the treatment aria skin.
Other: Thunbergia cream
Apply thunbergia cream to the treatment skin everyday after radiation therapy
Other Names:
  • Thunbergia laurifolia Lindl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of dermatitis grading
Time Frame: Change from baseline dermatitis grading at 1, 2, 3, 4, 5 weeks and at 9 week.
RTOG (Radiation Therapy Oncology Group) Cooperative Group Common Toxicity Criteria Skin Grade 0:None or no change Grade 1:Scattered macular or papular eruption or erythema that is asymptomatic Grade 2:Scattered macular or papular eruption or erythema with pruritis or other associated symptoms Grade 3:Generalized symptomatic macular, papular, or vesicular eruption Grade 4:Exfoliative dermatitis or ulcerating dermatitis Grade 5:If that toxicity caused the death of the patient.
Change from baseline dermatitis grading at 1, 2, 3, 4, 5 weeks and at 9 week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with the cream
Time Frame: At 9 week from date of randomization

Scoring 1-4

  1. not satisfied
  2. slightly satisfied
  3. moderately satisfied
  4. very satisfied
At 9 week from date of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulabhorn Cancer Center

Investigators

  • Principal Investigator: Saengrawee Thanthong, M.N.S., 54 moo 4 Kampangpet 6 Taladbangken Laksi Bangkok, THAILAND 10210

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

September 30, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Actual)

June 25, 2018

Last Update Submitted That Met QC Criteria

June 21, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005/2559

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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