Jerryes Pious Wisely, (2020) Barrier Skin Film vs. Steroid cream prophylaxis for prevention of radiation dermatitis in breast cancer women undergoing adjuvant radiation therapy. Masters thesis, Christian Medical College, Vellore.
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Abstract
OBJECTIVES: To study the efficacy of Barrier skin film (3M Cavilon) as compared to topical steroid cream (Mometasone Furoate) for the prophylaxis of radiation dermatitis from the start of radiotherapy up to 4 weeks post radiotherapy in women with breast cancer post mastectomy undergoing adjuvant radiotherapy. METHODS: This study is a Non-blinded Phase III Intra-Individual Randomised Controlled Clinical Trial. MMF - mometasone furoate or barrier skin film BSF - 3M Cavilon was applied to the affected chest wall on either the medial or lateral half starting from the first 1-3 days and assessment was done once at baseline, once every week until completion of radiation therapy and once after 4 weeks from completion of radiation therapy. The data collected were then analysed using Visual Analog Scale - VAS for pain, CTCAE v4.03 Radiation Dermatitis Score – Common Terminology Criteria for Adverse Events, RISRAS – Radiation Induced Skin Reaction Assessment Score, STAT – Skin Toxicity Assessment Tool, Skin associated quality of life assessment by SKINDEX 16 and Global Quality of life assessment by LASA – Linear Analog Scale Assessment. Categorical variables were summarised using counts and percentages. Quantitative variables were summarised using mean and standard deviation or median and IQR. Wilcoxon signed rank tests and chi-square tests were used to compare the proportions between the groups and paired sample t tests were used to compare means between the two treatment arms. RESULTS: Between April 2018 and June 2019, a total of 138 patients were screened, of which 90 patients were recruited for the study, 86 patients were included for analysis. There was a statistically significant association between the type of prophylactic agent and the development of pain score of 3 or more (p = 0.034). The incidence of grade II radiation dermatitis was higher in the barrier skin film arm (BSF) (27.9%) as compared to the mometasone furoate arm (MMF) (4.7%) (p = 0.000). The time to onset of grade II radiation dermatitis was 4.75 weeks in the MMF arm and 4.41 weeks in the BSF arm (p = 0.000). Among the quality of life scores, tenderness and discomfort were the most common symptom that was reported by all patients and patients in the MMF arm did better compared to the BSF arm (p = 0.000). CONCLUSION: Mometasone furoate (MMF) helps in the prevention of grade II or more radiation dermatitis and in delaying the onset of the same as compared to 3M Cavilon (Barrier skin film - BSF). MMF also reduces the incidence and severity of pain experienced by the patients and provides a better quality of life for breast cancer patients undergoing post-mastectomy adjuvant radiation therapy. Hence, Mometasone furoate should be the prophylactic agent of choice for the reduction of acute radiation dermatitis and improved patient comfort.
| Item Type: | Thesis (Masters) |
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| Additional Information: | 201719053 |
| Uncontrolled Keywords: | Post-mastectomy adjuvant radiation therapy, Radiation Dermatitis, Topical steroid cream, Mometasone furoate, Barrier skin film, 3M Cavilon, Pain score, Quality of life |
| Subjects: | MEDICAL > Radio Therapy |
| Depositing User: | Subramani R |
| Date Deposited: | 01 Feb 2021 03:18 |
| Last Modified: | 01 Feb 2021 03:25 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/13638 |
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