Clinical trial NCT02922244: Effects of Herbal Products on Reduction of Radiation-induced Dermatitis in Breast Cancer Patients
Official title: Effects of Herbal Products on Reduction of Radiation-induced Dermatitis in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiodermatitis
Breast Neoplasms
Adverse Effect of Radiation Therapy
Keywords: herbal products
reduction of radiation-induced dermatitis
breast cancer
radiotherapy
Lead sponsor: Chulabhorn Cancer Center
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of dermatitis grading
timeFrame: Change from baseline dermatitis grading at 1, 2, 3, 4, 5 weeks and at 9 week.
Secondary outcomes:
measure: Patient satisfaction with the cream
timeFrame: At 9 week from date of randomization
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: ChulaBhorn Hospital
Study officials:
affiliation: 54 moo 4 Kampangpet 6 Taladbangken Laksi Bangkok, THAILAND 10210
name: Saengrawee Thanthong, M.N.S.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Nema NK, Maity N, Sarkar B, Mukherjee PK. Cucumis sativus fruit-potential antioxidant, anti-hyaluronidase, and anti-elastase agent. Arch Dermatol Res. 2011 May;303(4):247-52. doi: 10.1007/s00403-010-1103-y. Epub 2010 Dec 14.
citation: Wei LS, Wee W. Chemical composition and antimicrobial activity of Cymbopogon nardus citronella essential oil against systemic bacteria of aquatic animals. Iran J Microbiol. 2013 Jun;5(2):147-52.