NCT07149506

Oral or Topical Catechins for Radiation Dermatitis

Efficacy of Oral or Topical Catechins vs. Placebo as an Adjuvant for the Prevention and Management of Radiation Dermatitis in Oncology Patients: a Randomized Trial

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: CARLOS FRANCISCO SAAVEDRA GARCIA · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Introduction Radiation-induced dermatitis (RID), which includes both acute and chronic forms, affects up to 95% of patients undergoing radiation therapy. Despite its high incidence, there are currently no validated prevention and management recommendations specifically for the mexican population. Catechins, particularly epigallocatechin gallate and epicatechin, are emerging as a promising and readily accessible therapeutic option for radiation damage in skin and other organs, including conditions like esophagitis, intestinal injury, and mucositis. Objective This study aims to evaluate the utility of oral or topical catechins in preventing and managing acute and chronic radiation-induced dermatitis in cancer patients, comparing their effectiveness against standard treatment. Material and Methods This will be a randomized, double-blind, phase III clinical trial with a longitudinal and comparative design. Patients will be allocated into two primary study groups: prevention (n=81) and treatment (n=81). Each group will be further divided into four treatment arms: Epigallocatechin gallate (experimental aerosol) Epicatechin (experimental capsule) Saline control arm (aerosol) Microcrystalline cellulose excipient control arm (capsule) All participants across all groups will receive standard care. Study endpoints will include the assessment of utility, toxicity, quality of life, and cosmesis, using various validated scales and scores. Ethics This study adheres to the principles outlined in the Helsinki Declaration (2024), the Nuremberg Code, and Mexico's General Health Law on health research. Given the wide therapeutic margin of the interventions, the study is classified as minimal risk. Statistical Analysis To evaluate the efficacy of the intervention (specifically, the change in the risk of dermatitis and fibrosis), we will calculate the hazard ratio using Cox regression and compare it with the Log-Rank test. Additionally, both fixed and random effects models will be performed and compared using the likelihood ratio test.

Conditions

• Radiation Dermatitis Acute
• Radiation Dermatitis
• Fibrosis; Skin

Interventions

Type	Name	Description
OTHER	Epicatechin	A comparison will be made between oral catechin (epicatechin) from two approaches: a preventive approach and a therapeutic approach.
OTHER	Epigallocatechin Gallate (EGCG)	A comparison will be made between topical catechin (EGCG) from two approaches: a preventive approach and a therapeutic approach.
OTHER	Microcrystalline Cellulose NF (placebo)	A comparison will be made between oral placebo (microcrystalline cellulose) from two approaches: a preventive approach and a therapeutic approach.
OTHER	Saline (0.9% NaCl)	A comparison will be made between topical placebo (0.9% saline solution) from two approaches: a preventive approach and a therapeutic approach.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-10-01
• Completion: 2027-03-01
• First posted: 2025-09-02
• Last updated: 2025-09-08

Locations

1 site across 1 country: Mexico