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

Primary Purpose

Radiodermatitis, Breast Neoplasms, Adverse Effect of Radiation Therapy

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Control
Cucumber cream
Centella cream
Thunbergia cream
Sponsored by
Chulabhorn Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiodermatitis focused on measuring herbal products, reduction of radiation-induced dermatitis, breast cancer, radiotherapy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ChulaBhorn Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Standard skin care

Control

Cucumber cream

Centella cream

Thunbergia cream

Arm Description

standard skin care

Moisture Cream

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient satisfaction with the cream
Scoring 1-4 not satisfied slightly satisfied moderately satisfied very satisfied

Full Information

First Posted
September 21, 2016
Last Updated
June 21, 2018
Sponsor
Chulabhorn Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02922244
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulabhorn Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiodermatitis, Breast Neoplasms, Adverse Effect of Radiation Therapy
Keywords
herbal products, reduction of radiation-induced dermatitis, breast cancer, radiotherapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard skin care
Arm Type
No Intervention
Arm Description
standard skin care
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Moisture Cream
Arm Title
Cucumber cream
Arm Type
Active Comparator
Arm Description
Apply Cucumber cream everyday after radiation therapy on the treatment aria skin.
Arm Title
Centella cream
Arm Type
Active Comparator
Arm Description
Apply Centella asiatica cream everyday after radiation therapy on the treatment aria skin.
Arm Title
Thunbergia cream
Arm Type
Active Comparator
Arm Description
Apply Thunbergia cream everyday after radiation therapy on the treatment aria skin.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Apply moisture cream to the treatment skin everyday after radiation therapy
Intervention Type
Other
Intervention Name(s)
Cucumber cream
Intervention Description
Apply cucumber cream to the treatment skin everyday after radiation therapy
Intervention Type
Other
Intervention Name(s)
Centella cream
Other Intervention Name(s)
Centella asiatica
Intervention Description
Apply centella cream to the treatment skin everyday after radiation therapy
Intervention Type
Other
Intervention Name(s)
Thunbergia cream
Other Intervention Name(s)
Thunbergia laurifolia Lindl
Intervention Description
Apply thunbergia cream to the treatment skin everyday after radiation therapy
Primary Outcome Measure Information:
Title
Change of dermatitis grading
Description
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.
Time Frame
Change from baseline dermatitis grading at 1, 2, 3, 4, 5 weeks and at 9 week.
Secondary Outcome Measure Information:
Title
Patient satisfaction with the cream
Description
Scoring 1-4 not satisfied slightly satisfied moderately satisfied very satisfied
Time Frame
At 9 week from date of randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saengrawee Thanthong, M.N.S.
Organizational Affiliation
54 moo 4 Kampangpet 6 Taladbangken Laksi Bangkok, THAILAND 10210
Official's Role
Principal Investigator
Facility Information:
Facility Name
ChulaBhorn Hospital
City
Bangkok
ZIP/Postal Code
10210
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
10443466
Citation
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.
Results Reference
result
PubMed Identifier
21694984
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.
Results Reference
result
PubMed Identifier
20118623
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. doi: 10.2131/jts.35.41.
Results Reference
result
PubMed Identifier
25525844
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.
Results Reference
result
PubMed Identifier
16893745
Citation
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.
Results Reference
result
PubMed Identifier
14566480
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. doi: 10.1007/s00066-003-1142-9.
Results Reference
result
PubMed Identifier
21153830
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.
Results Reference
result
PubMed Identifier
23825733
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.
Results Reference
result

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

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