NCT02922244

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 25, 2018

Status Verified

June 1, 2018

Enrollment Period

1.9 years

First QC Date

September 21, 2016

Last Update Submit

June 21, 2018

Conditions

RadiodermatitisBreast NeoplasmsAdverse Effect of Radiation Therapy

Keywords

herbal productsreduction of radiation-induced dermatitisbreast cancerradiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Patient satisfaction with the cream

    At 9 week from date of randomization

Study Arms (5)

Standard skin care

NO INTERVENTION

standard skin care

Control

PLACEBO COMPARATOR

Moisture Cream

Other: Control

Cucumber cream

ACTIVE COMPARATOR

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

Other: Cucumber cream

Centella cream

ACTIVE COMPARATOR

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

Other: Centella cream

Thunbergia cream

ACTIVE COMPARATOR

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

Other: Thunbergia cream

Interventions

ControlOTHER

Apply moisture cream to the treatment skin everyday after radiation therapy

Control
Cucumber creamOTHER

Apply cucumber cream to the treatment skin everyday after radiation therapy

Cucumber cream
Centella creamOTHER

Apply centella cream to the treatment skin everyday after radiation therapy

Also known as: Centella asiatica
Centella cream
Thunbergia creamOTHER

Apply thunbergia cream to the treatment skin everyday after radiation therapy

Also known as: Thunbergia laurifolia Lindl
Thunbergia cream

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 20 years old or older,
  • Diagnosed with Breast cancer
  • On course of external Radiation therapy

You may not qualify if:

  • Pregnant
  • Previously underwent external Radiation therapy
  • Illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChulaBhorn Hospital

Bangkok, 10210, Thailand

Location

Related 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. doi: 10.1248/bpb.22.703.

    PMID: 10443466RESULT

  • 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.

    PMID: 21694984RESULT

  • 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.

    PMID: 20118623RESULT

  • 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.

    PMID: 25525844RESULT

  • 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.

    PMID: 16893745RESULT

  • 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.

    PMID: 14566480RESULT

  • 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.

    PMID: 21153830RESULT

  • 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.

    PMID: 23825733RESULT

MeSH Terms

Conditions

RadiodermatitisBreast NeoplasmsRadiation Injuries

Interventions

Centella asiatica extract

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesWounds and InjuriesNeoplasms by SiteNeoplasmsBreast Diseases

Study Officials

  • Saengrawee Thanthong, M.N.S.

    54 moo 4 Kampangpet 6 Taladbangken Laksi Bangkok, THAILAND 10210

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2016

First Posted

October 4, 2016

Study Start

May 1, 2016

Primary Completion

April 1, 2018

Study Completion

June 1, 2018

Last Updated

June 25, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TH(1)