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NCT Number: NCT05079763

Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

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.

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Key information

Conditions

Acute Radiation Dermatitis Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Philippine General Hospital

Manila, 1000, Philippines

Location status: Recruiting

Location contact

Claudine Yap-Silva, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Already completed prescribed mastectomy and chemotherapy (adjuvant or neoadjuvant) interventions
  • Scheduled to receive hypo fractionated postmastectomy-postchemotherapy radiation therapy

Exclusion criteria

  • Pregnant or lactating
  • With concurrent or previous history of any malignancy
  • With history of mediastinal or thoracic irradiation
  • With current bilateral synchronous breast carcinoma
  • With diagnosis of metastases from any form of breast cancer
  • With any skin lesion in the planned radiation field deemed deramtologically and/or radiotherapeutically relevant
  • With concomitant disease states deemed clinically significant (connective tissue diseases, infections, uncontrolled chronic disorders, renal failure, hepatic dysfunction, etc.)
  • With known history of hypersensitivities and/or reactions against any component of either experimental or comparator interventions
  • Inability to personally provide informed consent or to personally comply with skin care instructions

Treatment and study plan

Bacterial cellulose-monolaurin hydrogel

Other

Hydrogel containing Komagataeibacter xylinus-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water

Placebo Cream

Other

Cream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben

Primary outcomes

  1. Incidence of high grade acute radiation dermatitis

    Time frame: Baseline to Week 4 post-radiotherapy

    High-grade acute radiation dermatitis is defined as Common Terminology Criteria for Adverse Events (CTCAE) grade of at least 3

Secondary outcomes

  1. Distribution of participants in terms of ARD CTCAE grades

    Time frame: Baseline to Week 4 post-radiotherapy

    Distribution of participants across the ARD CTCAE grades (0-5) in the two interventions will be compared

  2. Patient-reported quality of life

    Time frame: Baseline to Week 4 post-radiotherapy

    Outcome will be assessed using the Skindex-16 (SD-16) questionnaire, administered on a weekly basis from baseline up to two weeks post-radiotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Aedrian A Abrilla, MD

CONTACT

[email protected]

+639363193980

Claudine Yap-Silva, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of the Philippines

Other

Registry information

Official study title

Bacterial Cellulose-monolaurin Hydrogel for Preventing Therapy-induced High-grade Acute Dermatitis Among Filipinos With Breast Adenocarcinoma: a Pilot Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Oct 15, 2021
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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