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

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ClinicalTrials.gov Identifier: NCT02922244
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Saengrawee Thanthong, Chulabhorn Cancer Center

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

Condition or disease Intervention/treatment Phase
Radiodermatitis Breast Neoplasms Adverse Effect of Radiation Therapy Other: Control Other: Cucumber cream Other: Centella cream Other: Thunbergia cream Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Herbal Products on Reduction of Radiation-induced Dermatitis in Breast Cancer Patients
Study Start Date : May 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
No Intervention: Standard skin care
standard skin care
Placebo Comparator: Control
Moisture Cream
Other: Control
Apply moisture cream to the treatment skin everyday after radiation therapy

Active Comparator: Cucumber cream
Apply Cucumber cream everyday after radiation therapy on the treatment aria skin.
Other: Cucumber cream
Apply cucumber cream to the treatment skin everyday after radiation therapy

Active Comparator: Centella cream
Apply Centella asiatica cream everyday after radiation therapy on the treatment aria skin.
Other: Centella cream
Apply centella cream to the treatment skin everyday after radiation therapy
Other Name: Centella asiatica

Active Comparator: Thunbergia cream
Apply Thunbergia cream everyday after radiation therapy on the treatment aria skin.
Other: Thunbergia cream
Apply thunbergia cream to the treatment skin everyday after radiation therapy
Other Name: Thunbergia laurifolia Lindl




Primary Outcome Measures :
  1. Change of dermatitis grading [ Time Frame: Change from baseline dermatitis grading at 1, 2, 3, 4, 5 weeks and at 9 week. ]
    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 :
  1. Patient satisfaction with the cream [ Time Frame: At 9 week from date of randomization ]

    Scoring 1-4

    1. not satisfied
    2. slightly satisfied
    3. moderately satisfied
    4. very satisfied



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922244


Locations
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Thailand
ChulaBhorn Hospital
Bangkok, Thailand, 10210
Sponsors and Collaborators
Chulabhorn Cancer Center
Investigators
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Principal Investigator: Saengrawee Thanthong, M.N.S. 54 moo 4 Kampangpet 6 Taladbangken Laksi Bangkok, THAILAND 10210

Publications of Results:
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Responsible Party: Saengrawee Thanthong, Principal Investigator, Chulabhorn Cancer Center
ClinicalTrials.gov Identifier: NCT02922244    
Other Study ID Numbers: 005/2559
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Keywords provided by Saengrawee Thanthong, Chulabhorn Cancer Center:
herbal products
reduction of radiation-induced dermatitis
breast cancer
radiotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Dermatitis
Radiodermatitis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Radiation Injuries
Wounds and Injuries