| Registry | NCT02922244 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: triple, prevention |
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| Enrollment | 150 (Actual) |
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| Sponsor | Chulabhorn Cancer Center (Other) |
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| Conditions | Radiodermatitis, Breast Neoplasms, Adverse Effect of Radiation Therapy |
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| Interventions | Control, Cucumber cream, Centella cream, Thunbergia cream (Other) |
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| Dates | start 2016-05-01, primary completion 2018-04-01, completion 2018-06-01, first posted 2016-10-04, last updated 2018-06-25 |
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| Locations | 1 site in Thailand |
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Related Papers Related Patents Related Grants Related Experts
All trials for Radiodermatitis All trials for Breast Neoplasms All trials of Control All trials of Cucumber cream
-Summary
The herbal products on reduction of radiation-induced dermatitis in patients with breast cancer
Expand all sections · Collapse all
+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Standard skin care | No intervention | | standard skin care |
| Control | Placebo comparator | Other: Control | Moisture Cream |
| Cucumber cream | Active comparator | Other: Cucumber cream | Apply Cucumber cream everyday after radiation therapy on the treatment aria skin. |
| Centella cream | Active comparator | Other: Centella cream | Apply Centella asiatica cream everyday after radiation therapy on the treatment aria skin. |
| Thunbergia cream | Active comparator | Other: Thunbergia cream | Apply Thunbergia cream everyday after radiation therapy on the treatment aria skin. |
- Control (Other): Apply moisture cream to the treatment skin everyday after radiation therapy
- Cucumber cream (Other): Apply cucumber cream to the treatment skin everyday after radiation therapy
- Centella cream (Other), also known as Centella asiatica: Apply centella cream to the treatment skin everyday after radiation therapy
- Thunbergia cream (Other), also known as Thunbergia laurifolia Lindl: Apply thunbergia cream to the treatment skin everyday after radiation therapy
+Outcome measures
Primary outcomes
- Change of dermatitis grading [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 outcomes
- Patient satisfaction with the cream [At 9 week from date of randomization]: Scoring 1-4
1. not satisfied
2. slightly satisfied
3. moderately satisfied
4. very satisfied
+Eligibility
Sex: All, ages: 20 Years to 80 Years
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
+Locations (1)
| Facility | City | Country | Status |
|---|
| ChulaBhorn Hospital | Bangkok | Thailand | |
+Publications
- Results publication: 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 10443466
- Results publication: 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 21694984
- Results publication: 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 20118623
- Results publication: 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 25525844
- Results publication: 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 16893745
- Results publication: 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 14566480
- Results publication: 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 21153830
- Results publication: 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 23825733
+Investigators