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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02922244
Enrollment
150
Registered
2016-10-04
Start date
2016-05-31
Completion date
2018-06-30
Last updated
2018-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effect of Radiation Therapy, Breast Neoplasms, Radiodermatitis

Keywords

herbal products, reduction of radiation-induced dermatitis, breast cancer, radiotherapy

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.

Interventions

OTHERControl

Apply moisture cream to the treatment skin everyday after radiation therapy

OTHERCucumber cream

Apply cucumber cream to the treatment skin everyday after radiation therapy

OTHERCentella cream

Apply centella cream to the treatment skin everyday after radiation therapy

OTHERThunbergia cream

Apply thunbergia cream to the treatment skin everyday after radiation therapy

Sponsors

Chulabhorn Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of dermatitis gradingChange 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

MeasureTime frameDescription
Patient satisfaction with the creamAt 9 week from date of randomizationScoring 1-4 1. not satisfied 2. slightly satisfied 3. moderately satisfied 4. very satisfied

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026