Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis
Philippines54 participantsStarted 2021-09-01
Plain-language summary
Acute radiation dermatitis (ARD) is almost universally experienced by patients with cancer during or after radiation therapy. This condition potentially leads to detrimental clinical outcomes as it adversely affects adherence to prescribed subsequent management and further worsens quality of life. Nevertheless, there remains no consensus on the appropriate intervention for ARD. This pilot two parallel-group randomized trial aims to clinically assess the potential of bacterial cellulose-monolaurin hydrogel, compared to placebo cream, to prevent high-grade ARD among Filipinos with breast cancer up to four weeks after last radiotherapy session.
Who can participate
Age range
18 Years – 80 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:
* Female sex at birth
* Age at least 18 years at the time of invitation
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of either 0 or 1
* With histopathologic diagnosis of breast carcinoma
* Already completed prescribed mastectomy and chemotherapy (adjuvant or neoadjuvant) interventions
* Scheduled to receive hypo fractionated postmastectomy-postchemotherapy radiation therapy
Exclusion Criteria:
* Pregnant or lactating
* With concurrent or previous history of any malignancy
* With history of mediastinal or thoracic irradiation
* With current bilateral synchronous breast carcinoma
* With diagnosis of metastases from any form of breast cancer
* With any skin lesion in the planned radiation field deemed deramtologically and/or radiotherapeutically relevant
* With concomitant disease states deemed clinically significant (connective tissue diseases, infections, uncontrolled chronic disorders, renal failure, hepatic dysfunction, etc.)
* With known history of hypersensitivities and/or reactions against any component of either experimental or comparator interventions
* Inability to personally provide informed consent or to personally comply with skin care instructions
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
Incidence of high grade acute radiation dermatitis