NCT05079763 Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis
| NCT ID | NCT05079763 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of the Philippines |
| Condition | Acute Radiation Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2021-09-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05079763 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 80 Years, studying Acute Radiation Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05079763 currently recruiting?
Yes, NCT05079763 is actively recruiting participants. Contact the research team at aaabrilla@up.edu.ph for enrollment information.
Where is the NCT05079763 trial being conducted?
This trial is being conducted at Manila, Philippines.
Who is sponsoring the NCT05079763 clinical trial?
NCT05079763 is sponsored by University of the Philippines. The trial plans to enroll 54 participants.