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Completed

NCT Number: NCT02922244

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

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

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Key information

Conditions

Radiodermatitis Adverse Effect of Radiation Therapy Breast Diseases Breast Neoplasms Dermatitis Neoplasms Neoplasms by Site Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ChulaBhorn Hospital

Bangkok, 10210, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Other

Apply moisture cream to the treatment skin everyday after radiation therapy

Cucumber cream

Other

Apply cucumber cream to the treatment skin everyday after radiation therapy

Centella cream

Other

Apply centella cream to the treatment skin everyday after radiation therapy

Other names: Centella asiatica

Thunbergia cream

Other

Apply thunbergia cream to the treatment skin everyday after radiation therapy

Other names: Thunbergia laurifolia Lindl

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient satisfaction with the cream

    Time frame: At 9 week from date of randomization

    Scoring 1-4

    • not satisfied
    • slightly satisfied
    • moderately satisfied
    • very satisfied

Sponsors and collaborators

Lead sponsor

Chulabhorn Cancer Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 4, 2016
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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