Efficacy of Topical Betamethasone Valerate and Olive Oil in Preventing Acute Radiation Dermatitis in Breast Cancer: A Randomized Double-Blind Placebo-Controlled Study.

2026-01
Clinical breast cancer 26(1)
- Israa K Mohamed
- Maggie M Abbassi
- Mohamed R Kelany
- Samar F Farid

PubMed: 40973558
DOI: 10.1016/j.clbc.2025.08.008

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 132
Population: breast cancer patients
Methods: prospective, double-blind, randomized, parallel, placebo-controlled trial; patients randomized to receive either olive oil cream, betamethasone-17-valerate, or unmedicated cream base throughout radiotherapy and 2 weeks after
Blinding: Double-blind
Duration: throughout radiotherapy and 2 weeks after

Large Human Trial

Aim

The purpose of this study is to compare topical betamethasone-17-valerate and olive oil cream in preventing radiation-induced dermatitis (RID) in breast cancer patients and to provide prospective data evaluating the quality of life, subjective symptoms, and treatment satisfaction reported by the patients.

Methods

This was a prospective, double-blind, randomized, parallel, placebo-controlled trial. A total of 132 patients were randomized into three groups to receive either olive oil cream (G1), betamethasone-17-valerate (Betnovate® cream, GlaxoSmithKline) (G2), or unmedicated cream base (G3) throughout radiotherapy (RT) and 2 weeks after. The study is registered on clinicaltrials.gov with ID: NCT05285943, Date: November 2021.

Results

A total of 128 patients were included in the final analysis. Betamethasone and olive oil significantly differed from the unmedicated cream base at weeks 1 to 4 (P < 0.05). At week 5, only significance was observed between olive oil and unmedicated cream base (P = 0.013), and the mean RTOG (Radiation Therapy Oncology Group) score was significantly lower in olive oil and betamethasone groups than in the unmedicated cream base group (P < 0.05 at weeks 1-5) but, there was no significant difference between olive oil and betamethasone (P > 0.999). Furthermore, the percentage of patients who developed grade 3 at the end of the follow-up was significantly different between the olive oil group and the unmedicated cream base group (27.9% vs. 61%, P = 0.004). Additionally, olive oil and betamethasone had non-significant delayed grade 2 and grade 3 development (P > 0.999).

Conclusion

Olive oil cream is as effective as betamethasone in alleviating RID in patients treated with adjuvant radiotherapy for breast cancer.

Research Insights

Olive Oil→Delayed Onset of Grade 2 Dermatitis
Additionally, olive oil and betamethasone had non-significant delayed grade 2 and grade 3 development (P > 0.999).
Effect
Neutral
Effect size
Small
Olive Oil→Delayed Onset of Grade 3 Dermatitis
Additionally, olive oil and betamethasone had non-significant delayed grade 2 and grade 3 development (P > 0.999).
Effect
Neutral
Effect size
Small
Olive Oil→Reduced Dermatitis Incidence
Furthermore, the percentage of patients who developed grade 3 at the end of the follow-up was significantly different between the olive oil group and the unmedicated cream base group (27.9% vs. 61%, P = 0.004).
Effect
Beneficial
Effect size
Large
Olive Oil→Reduced Radiation-Induced Dermatitis Severity
Betamethasone and olive oil significantly differed from the unmedicated cream base at weeks 1 to 4 (P < 0.05). At week 5, only significance was observed between olive oil and unmedicated cream base (P = 0.013), and the mean RTOG score was significantly lower in olive oil and betamethasone groups than in the unmedicated cream base group (P < 0.05 at weeks 1-5) but, there was no significant difference between olive oil and betamethasone (P > 0.999).
Effect
Beneficial
Effect size
Moderate