Preventive Effect of Boron-based Gel on Radiation Dermatitis

NCT04239560 | Completed Phase 3 DMC

• 1 other identifier: TBMZ-Radio-boron gel
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

Brief Summary

Preventive Effect of Boron-based Gel on Radiation Dermatitis

Conditions

Radiodermatitis

Keywords

Radiodermatitis; Gel; Boron; Radiotherapy; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Radiation Therapy Oncology Group (RTOG) criteria

  including erythema, dry desquamation, moist desquamation and necrosis

  The study's outcomes were examined at 25th day of treatment for the patients in two groups

Study Arms (2)

Boron-based Gel

EXPERIMENTAL

During each radiation therapy session, 15 minutes before radiotherapy, 3% sodium pentahydrate panteurate will be used.

Drug: Boron-based Gel (Fibore)

Radiation Traumatic Dermatitis Treated with Placebo

PLACEBO COMPARATOR

During each radiotherapy session, 15 minutes before radiotherapy, the gel will be free of any chemical treatments

Drug: Placebos

Interventions

Boron-based Gel (Fibore) DRUG

During each radiotherapy session, 15 minutes before radiotherapy, the gel used and patients followed up.

Also known as: Fibore

Boron-based Gel

Placebos DRUG

During each radiotherapy session, 15 minutes before radiotherapy, the Placebo gel which be free of any chemical used and patients followed up.

Also known as: No chemical

Radiation Traumatic Dermatitis Treated with Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are admitted to the study are enrolled in the study and have head and neck cancer in the breast, and are between the ages of 18 and 75 years old and have not received radiotherapy before.

You may not qualify if:

• Pregnant women, patients with unknown dermatitis and those without any willing to participate in this study were excluded.

Sponsors & Collaborators

• Tabriz University of Medical Sciences: lead

Study Sites (1)

Shahid Madani Medical & Training Hospital - Department of Radiotherapy

Tabriz, East Azerbaijan Province, 5166614766, Iran

Location

MeSH Terms

Conditions

Radiodermatitis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases

Study Officials

• Farshad SeyedNejad, MD

  Tabriz University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: A gel that has an active ingredient in boron with a gel that does not have a substance and is used as a placebo is completely identical in terms of the shape and size of the container, and the gels themselves do not differ in terms of odor and color, and are completely indistinguishable. (This action was taken by the pharmaceutical company). The important point is that the patient is told that the gel used for the patient may be medication or medication. Clinicians and blind patients will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Epidemiology

Model Details: The aim of the study was fully described to the eligible subjects and informed consent was gathered. Afterwards, the patients were assigned into the intervention and placebo groups. In the intervention and placebo groups, subjects received daily a gel containing 3% sodium pentaborate pentahydrate and gel free of any chemical treatment respectively 15 minutes before the radiotherapy session. As the gels were used on the target areas of the patients by the researchers, there was no compliance problem in this study. Afterwards, the study's outcomes were examined at 25th day of treatment for the patients in two groups.

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 27, 2020
• Study Start: February 4, 2019
• Primary Completion: September 21, 2019
• Study Completion: December 21, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after being published
• Access Criteria: No limitation

Locations

IR (1)