Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | 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 |
|
| Placebo Arm | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacterial cellulose-monolaurin hydrogel | Other | Hydrogel containing Komagataeibacter xylinus-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to Week 4 post-radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to Week 4 post-radiotherapy |
| Patient-reported quality of life |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aedrian A Abrilla, MD | Contact | +639363193980 | aaabrilla@up.edu.ph | |
| Claudine Yap-Silva, MD | Contact | cysilva@up.edu.ph |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philippine General Hospital | Recruiting | Manila | 1000 | Philippines |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Bacterial cellulose-monolaurin hydrogel
Not provided
Not provided
Not provided
| Placebo cream | Other | Cream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben |
|
Outcome will be assessed using the Skindex-16 (SD-16) questionnaire, administered on a weekly basis from baseline up to two weeks post-radiotherapy
| Baseline to Week 4 post-radiotherapy |
| D017437 |
| Skin and Connective Tissue Diseases |