An interventional study of Bacterial cellulose-monolaurin hydrogel and Placebo cream in Acute Radiation Dermatitis, sponsored by University of the Philippines. Recruiting at 1 site in Philippines. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by University of the Philippines · Not applicable, Interventional, and Prevention
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 54 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of the Philippines is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Bacterial cellulose-monolaurin hydrogel
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
Other: Placebo cream
Hydrogel containing Komagataeibacter xylinus-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water
Cream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben
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-radiotherapy
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-radiotherapy
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-radiotherapy
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University of the Philippines