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

Not Applicable

Completed

• Conditions: Adverse Effect of Radiation Therapy; Breast Neoplasms; Radiodermatitis

• Registration Number: NCT02922244
• Lead Sponsor: Chulabhorn Cancer Center

Brief Summary

The herbal products on reduction of radiation-induced dermatitis in patients with breast cancer

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 Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-09-30
• Study First Posted: 2016-10-04
• Primary Completion: 2018-04
• Status Verified: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2018-06-21
• Last Update Posted: 2018-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of dermatitis grading	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.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with the cream	At 9 week from date of randomization	Scoring 1-4; 1. not satisfied; 2. slightly satisfied; 3. moderately satisfied; 4. very satisfied

Trial Locations

Locations (1)

ChulaBhorn Hospital; 🇹🇭 Bangkok, Thailand