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

NCT ID: NCT02922244

Last Updated: 2018-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Radiodermatitis Breast Neoplasms Adverse Effect of Radiation Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Standard skin care

standard skin care

Group Type NO_INTERVENTION

No interventions assigned to this group

Control

Moisture Cream

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

Apply moisture cream to the treatment skin everyday after radiation therapy

Cucumber cream

Apply Cucumber cream everyday after radiation therapy on the treatment aria skin.

Group Type ACTIVE_COMPARATOR

Cucumber cream

Intervention Type OTHER

Apply cucumber cream to the treatment skin everyday after radiation therapy

Centella cream

Apply Centella asiatica cream everyday after radiation therapy on the treatment aria skin.

Group Type ACTIVE_COMPARATOR

Centella cream

Intervention Type OTHER

Apply centella cream to the treatment skin everyday after radiation therapy

Thunbergia cream

Apply Thunbergia cream everyday after radiation therapy on the treatment aria skin.

Group Type ACTIVE_COMPARATOR

Thunbergia cream

Intervention Type OTHER

Apply thunbergia cream to the treatment skin everyday after radiation therapy

Interventions

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Control

Apply moisture cream to the treatment skin everyday after radiation therapy

Intervention Type OTHER

Cucumber cream

Apply cucumber cream to the treatment skin everyday after radiation therapy

Intervention Type OTHER

Centella cream

Apply centella cream to the treatment skin everyday after radiation therapy

Intervention Type OTHER

Thunbergia cream

Apply thunbergia cream to the treatment skin everyday after radiation therapy

Intervention Type OTHER

Other Intervention Names

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Centella asiatica Thunbergia laurifolia Lindl

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulabhorn Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Saengrawee Thanthong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saengrawee Thanthong, M.N.S.

Role: PRINCIPAL_INVESTIGATOR

54 moo 4 Kampangpet 6 Taladbangken Laksi Bangkok, THAILAND 10210

Locations

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ChulaBhorn Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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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. doi: 10.1248/bpb.22.703.

Reference Type RESULT
PMID: 10443466 (View on PubMed)

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.

Reference Type RESULT
PMID: 21694984 (View on PubMed)

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. doi: 10.2131/jts.35.41.

Reference Type RESULT
PMID: 20118623 (View on PubMed)

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.

Reference Type RESULT
PMID: 25525844 (View on PubMed)

McQuestion M. Evidence-based skin care management in radiation therapy. Semin Oncol Nurs. 2006 Aug;22(3):163-73. doi: 10.1016/j.soncn.2006.04.004.

Reference Type RESULT
PMID: 16893745 (View on PubMed)

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. doi: 10.1007/s00066-003-1142-9.

Reference Type RESULT
PMID: 14566480 (View on PubMed)

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.

Reference Type RESULT
PMID: 21153830 (View on PubMed)

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.

Reference Type RESULT
PMID: 23825733 (View on PubMed)

Other Identifiers

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005/2559

Identifier Type: -

Identifier Source: org_study_id

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