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Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

Primary Purpose

Acute Radiation Dermatitis

Status
Unknown status
Phase
Phase 2
Locations
Philippines
Study Type
Interventional
Intervention
Bacterial cellulose-monolaurin hydrogel
Placebo cream
Sponsored by
University of the Philippines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Radiation Dermatitis focused on measuring ARD, postmastectomy, breast cancer, breast adenocarcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Philippine General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental arm

Placebo Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
October 4, 2021
Last Updated
September 15, 2022
Sponsor
University of the Philippines
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1. Study Identification

Unique Protocol Identification Number
NCT05079763
Brief Title
Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis
Official Title
Bacterial Cellulose-monolaurin Hydrogel for Preventing Therapy-induced High-grade Acute Dermatitis Among Filipinos With Breast Adenocarcinoma: a Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Philippines

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Acute radiation dermatitis (ARD) is almost universally experienced by patients with cancer during or after radiation therapy. This condition potebtxallt 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Radiation Dermatitis
Keywords
ARD, postmastectomy, breast cancer, breast adenocarcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Bacterial cellulose-monolaurin hydrogel
Intervention Description
Hydrogel containing Komagataeibacter bylines-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water
Intervention Type
Other
Intervention Name(s)
Placebo cream
Intervention Description
Cream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben
Primary Outcome Measure Information:
Title
Incidence of high grade acute radiation dermatitis
Description
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
Secondary Outcome Measure Information:
Title
Distribution of participants in terms of ARD CTCAE grades
Description
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
Title
Patient-reported quality of life
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soraya Elisse Escandor, MD
Email
seescandor@up.edu.ph
Facility Information:
Facility Name
Philippine General Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soraya Elisse Escandor, MD

12. IPD Sharing Statement

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Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

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