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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922244
• Other study ID #: 005/2559
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: June 2018

Study information

• Verified date: June 2018
• Source: Chulabhorn Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adverse Effect of Radiation Therapy
• Breast Neoplasms
• Dermatitis
• Radiodermatitis

Intervention

Other:
• Control
Apply moisture cream to the treatment skin everyday after radiation therapy
• Cucumber cream
Apply cucumber cream to the treatment skin everyday after radiation therapy
• Centella cream
Apply centella cream to the treatment skin everyday after radiation therapy
• Thunbergia cream
Apply thunbergia cream to the treatment skin everyday after radiation therapy

Locations

Country	Name	City	State
Thailand	ChulaBhorn Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulabhorn Cancer Center

Country where clinical trial is conducted

Thailand, 

References & Publications (8)

Chen YJ, Dai YS, Chen BF, Chang A, Chen HC, Lin YC, Chang KH, Lai YL, Chung CH, Lai YJ. The effect of tetrandrine and extracts of Centella asiatica on acute radiation dermatitis in rats. Biol Pharm Bull. 1999 Jul;22(7):703-6. — View Citation

Gohil KJ, Patel JA, Gajjar AK. Pharmacological Review on Centella asiatica: A Potential Herbal Cure-all. Indian J Pharm Sci. 2010 Sep;72(5):546-56. doi: 10.4103/0250-474X.78519. — View Citation

Haleagrahara N, Ponnusamy K. Neuroprotective effect of Centella asiatica extract (CAE) on experimentally induced parkinsonism in aged Sprague-Dawley rats. J Toxicol Sci. 2010 Feb;35(1):41-7. — View Citation

Johnke RM, Sattler JA, Allison RR. Radioprotective agents for radiation therapy: future trends. Future Oncol. 2014 Dec;10(15):2345-57. doi: 10.2217/fon.14.175. Review. — View Citation

McQuestion M. Evidence-based skin care management in radiation therapy. Semin Oncol Nurs. 2006 Aug;22(3):163-73. Review. — View Citation

Momm F, Weissenberger C, Bartelt S, Henke M. Moist skin care can diminish acute radiation-induced skin toxicity. Strahlenther Onkol. 2003 Oct;179(10):708-12. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of dermatitis grading	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	Patient satisfaction with the cream	Scoring 1-4; not satisfied; slightly satisfied; moderately satisfied; very satisfied	At 9 week from date of randomization