RecruitingNot ApplicableNCT05079763

Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

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


Sponsor

University of the Philippines

Enrollment

54 participants

Start Date

Sep 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a special skin gel made from bacterial cellulose and a natural antimicrobial compound (monolaurin) to help prevent or treat radiation-related skin irritation (acute radiation dermatitis) in breast cancer patients receiving radiation after mastectomy. **You may be eligible if...** - You are female (assigned female at birth), 18 or older - You have been diagnosed with breast cancer and have already completed mastectomy and chemotherapy - You are scheduled to receive hypo-fractionated radiation therapy after mastectomy - Your general health is good (ECOG 0–1) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have had prior chest or breast radiation - You have a history of another cancer - You have connective tissue disease, active skin conditions in the radiation area, or uncontrolled chronic diseases - You have a known allergy to any component of the gels being tested Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBacterial cellulose-monolaurin hydrogel

Hydrogel containing Komagataeibacter xylinus-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water

OTHERPlacebo cream

Cream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben


Locations(1)

Philippine General Hospital

Manila, Philippines

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NCT05079763


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