Bacterial Cellulose-monolaurin Hydrogel for Preventing Therapy-induced High-grade Acute Dermatitis Among Filipinos With Breast Adenocarcinoma: a Pilot Randomized Controlled Trial
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.
• 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