Bacterial Cellulose-monolaurin Hydrogel for Acute 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

Qualifiers

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

Treatments tested in this trial

  • Bacterial cellulose-monolaurin hydrogel
  • Placebo cream

Treatment groups

54 Participants
are divided into 2 treatment groups

Sponsors and collaborators