Use of Topical Olive Oil Cream for Prophylaxis Against Acute Radiodermatitis in Breast Cancer Pat… (NCT05285943) | Clinical Trial Compass
CompletedPhase 4
Use of Topical Olive Oil Cream for Prophylaxis Against Acute Radiodermatitis in Breast Cancer Patients
Egypt132 participantsStarted 2021-11-04
Plain-language 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).
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acute Radiation Dermatitis (ARD) grading
Timeframe: T1=7 days after beginning treatment +/- 3 days; to T8=56 days after beginning treatment+/- 3 days}.