Use of Topical Olive Oil Cream for Prophylaxis Against Acute Radiodermatitis in Breast Cancer Patients

NCT05285943 | Completed Phase 4 DMC

• 1 other identifier: CL 2775
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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

Radiodermatitis; Acute

Keywords

Acute Radiodermatitis; Breast Cancer; Olive Oil

Outcome Measures

Primary Outcomes (1)

• Acute Radiation Dermatitis (ARD) grading

  • Development and degree of ARD grading according to Radiation Toxicity Grading (RTOG) skin toxicity score

  T1=7 days after beginning treatment +/- 3 days; to T8=56 days after beginning treatment+/- 3 days}.

Secondary Outcomes (2)

• Quality of Life questionnaire

  {T1=7 days after beginning treatment +/- 3 days to T8=56 days after beginning treatment+/- 3 days} .

• Patient Satisfaction

  Two weeks post the last dose of radiation therapy

Other Outcomes (2)

• Subjective Symptoms

  Weekly During Radiation Therapy up to 8 weeks

• Skin Infections During Treatment

  During the whole study (from recruitment and as long as patient is receiving radiation therapy)up to 8 weeks

Study Arms (3)

Betamethasone cream

ACTIVE COMPARATOR

Patients will apply Betamethasone Valerate 0.1% cream to the irradiated area twice a day.

Drug: Betamethasone Valerate Cream

Olive oil cream

ACTIVE COMPARATOR

Patients will apply prepared Olive Oil cream to the irradiated area twice a day.

Drug: Olive oil cream

Base cream

PLACEBO COMPARATOR

Patients will apply prepared base cream to the irradiated area twice a day.

Other: Base Cream

Interventions

Olive oil cream DRUG

Olive oil prepared in a base cream to be applied to irradiated areas.

Olive oil cream

Betamethasone Valerate Cream DRUG

Betamethasone valerate prepared in a base cream to be applied to irradiated areas.

Betamethasone cream

Base Cream OTHER

The base cream used for preparation of both the betamethasone valerate cream and olive cream will be used as a placebo control to be applied to irradiated areas.

Base cream

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

Related Publications (7)

• McQuestion 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 BACKGROUND

• Fuzissaki 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 BACKGROUND

• Ulff 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 BACKGROUND

• Cui 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 BACKGROUND

• Ulff 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 BACKGROUND

• Peipert 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 BACKGROUND

• Mohamed 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.

  PMID: 40973558 DERIVED

MeSH Terms

Conditions

Radiodermatitis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of Clinical Pharmacy Department

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: March 18, 2022
• Study Start: November 4, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 12, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)