Clinical trial · Interventional
Use of Topical Olive Oil Cream for Prophylaxis Against Acute Radiodermatitis in Breast Cancer Patients
A Comparative Study Between Topical Betamethasone Cream or Topical Olive Oil Cream in Prophylaxis Against Acute Radiodermatitis in Breast Cancer Patients.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to compare the prophylactic effect of topical betamethasone valerate cream and topical olive oil cream in the prevention of acute radiation dermatitis (ARD) in breast cancer patients treated with radiation. Betamethasone valerate, olive oil cream and the base cream will be compared in a randomized trial to evaluate and compare the development and degree of ARD grading according to Radiation Toxicity Grading (RTOG) skin toxicity score, percentage of patients with the maximum observed ARD grade for each arm of the study, percentage of patients with moist desquamation for each arm of the study, percentage of radiodermatitis-free patients at end of therapy (EOT=time point specifically at end of 2 weeks post radiation therapy). In addition, the patients' quality of life will be evaluated using Dermatology Life Quality Index (DLQI).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiodermatitis; Acute | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Base Cream | Other | — | UNRESOLVED |
| Betamethasone Valerate Cream | Drug | — | UNRESOLVED |
| Olive oil cream | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Betamethasone cream
- description
- Patients will apply Betamethasone Valerate 0.1% cream to the irradiated area twice a day.
- interventionNames
- Drug: Betamethasone Valerate Cream
- type
- ACTIVE_COMPARATOR
- label
- Olive oil cream
- description
- Patients will apply prepared Olive Oil cream to the irradiated area twice a day.
- interventionNames
- Drug: Olive oil cream
- type
- PLACEBO_COMPARATOR
- label
- Base cream
- description
- Patients will apply prepared base cream to the irradiated area twice a day.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological confirmation of breast malignancy, * Surgical intervention for carcinoma of the breast with or without lymph node metastasis. * Treatment with planned course of radiation therapy 5 days a week for 3-6 weeks. * Good Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1). * Total radiation dose of ≥42 Gy. Exclusion Criteria: * Pregnant and lactating mothers. * Previous radiation to the chest or breast area. * Concomitant chemotherapy. * Concomitant medication that may cause skin reactions. * Use of any other product on the skin at the treatment site at any time of the study. * Active dermatitis, history of autoimmune and connective tissue diseases, skin inflammatory diseases or any other specific skin disease. * Treatment with local or oral corticosteroid, or antioxidant medications. * Allergy to olive oil. * Inflammatory carcinoma of the breast as well as those with a known allergy to olive oil.
References
Publications (7)
- BACKGROUNDMcQuestion M. Evidence-based skin care management in radiation therapy: clinical update. Semin Oncol Nurs. 2011 May;27(2):e1-17. doi: 10.1016/j.soncn.2011.02.009. PMID 21514477
- BACKGROUNDFuzissaki MA, Paiva CE, Oliveira MA, Lajolo Canto PP, Paiva Maia YC. The Impact of Radiodermatitis on Breast Cancer Patients' Quality of Life During Radiotherapy: A Prospective Cohort Study. J Pain Symptom Manage. 2019 Jul;58(1):92-99.e1. doi: 10.1016/j.jpainsymman.2019.03.017. Epub 2019 Apr 8. PMID 30974233
- BACKGROUNDUlff E, Maroti M, Serup J, Falkmer U. A potent steroid cream is superior to emollients in reducing acute radiation dermatitis in breast cancer patients treated with adjuvant radiotherapy. A randomised study of betamethasone versus two moisturizing creams. Radiother Oncol. 2013 Aug;108(2):287-92. doi: 10.1016/j.radonc.2013.05.033. Epub 2013 Jul 2. PMID 23827771
- BACKGROUNDCui Z, Xin M, Yin H, Zhang J, Han F. Topical use of olive oil preparation to prevent radiodermatitis: results of a prospective study in nasopharyngeal carcinoma patients. Int J Clin Exp Med. 2015 Jul 15;8(7):11000-6. eCollection 2015. PMID 26379896
- BACKGROUNDUlff E, Maroti M, Serup J, Nilsson M, Falkmer U. Prophylactic treatment with a potent corticosteroid cream ameliorates radiodermatitis, independent of radiation schedule: A randomized double blinded study. Radiother Oncol. 2017 Jan;122(1):50-53. doi: 10.1016/j.radonc.2016.11.013. Epub 2016 Nov 29. PMID 27913066
- BACKGROUNDPeipert JD, Beaumont JL, Bode R, Cella D, Garcia SF, Hahn EA. Development and validation of the functional assessment of chronic illness therapy treatment satisfaction (FACIT TS) measures. Qual Life Res. 2014 Apr;23(3):815-24. doi: 10.1007/s11136-013-0520-8. Epub 2013 Sep 24. PMID 24062239
- DERIVEDMohamed IK, Abbassi MM, Kelany MR, Farid SF. Efficacy of Topical Betamethasone Valerate and Olive Oil in Preventing Acute Radiation Dermatitis in Breast Cancer: A Randomized Double-Blind Placebo-Controlled Study. Clin Breast Cancer. 2026 Jan;26(1):348-359.e1. doi: 10.1016/j.clbc.2025.08.008. Epub 2025 Aug 21.