Your session is about to expire
← Back to Search
Other
Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis
Phase 2
Waitlist Available
Research Sponsored by University of the Philippines
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 4 post-radiotherapy
Summary
Acute radiation dermatitis (ARD) is almost universally experienced by patients with cancer during or after radiation therapy. This condition potebtxallt 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.
Eligible Conditions
- Radiation Dermatitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 4 post-radiotherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 4 post-radiotherapy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of high grade acute radiation dermatitis
Secondary study objectives
Distribution of participants in terms of ARD CTCAE grades
Patient-reported quality of life
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental armExperimental Treatment1 Intervention
Application of bacterial cellulose-monolaurin hydrogel in the prescribed area for every 12 hours starting from receipt of first radiotherapy until development of moist desquamation or two week after completion of radiotherapy plan
Group II: Placebo ArmPlacebo Group1 Intervention
Application of placebo cream in the prescribed area for every 12 hours starting from receipt of first radiotherapy until development of moist desquamation or two week after completion of radiotherapy plan
Find a Location
Who is running the clinical trial?
University of the PhilippinesLead Sponsor
30 Previous Clinical Trials
19,383 Total Patients Enrolled