Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis
ConditionAcute Radiation Dermatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorUniversity of the Philippines
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnant or lactating
With concurrent or previous history of any malignancy
With history of mediastinal or thoracic irradiation
With current bilateral synchronous breast carcinoma
Trial design
Design model
Parallel
Treatments tested in this trial
Bacterial cellulose-monolaurin hydrogel
Other interventionHydrogel containing Komagataeibacter xylinus-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water
Placebo cream
Other interventionCream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Experimental armExperimental treatment 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of high grade acute radiation dermatitis
High-grade acute radiation dermatitis is defined as Common Terminology Criteria for Adverse Events (CTCAE) grade of at least 3
Time frame
Baseline to Week 4 post-radiotherapySecondary outcomes
1
Distribution of participants in terms of ARD CTCAE grades
Distribution of participants across the ARD CTCAE grades (0-5) in the two interventions will be compared
Time frame
Baseline to Week 4 post-radiotherapy2
Patient-reported quality of life
Outcome will be assessed using the Skindex-16 (SD-16) questionnaire, administered on a weekly basis from baseline up to two weeks post-radiotherapy
Time frame
Baseline to Week 4 post-radiotherapySponsors and contacts
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Source ClinicalTrials.gov