Oral or Topical Catechins for Radiation Dermatitis (OCTOPUS-RD)

CARLOS FRANCISCO SAAVEDRA GARCIA

Status and phase: Invitation-only; Phase 3

Conditions: Fibrosis; Skin; Radiation Dermatitis Acute; Radiation Dermatitis

Treatments: Other: Epigallocatechin Gallate (EGCG); Other: Saline (0.9% NaCl); Other: Microcrystalline Cellulose NF (placebo); Other: Epicatechin

Study type: Interventional

Funder types: Other

Identifiers

NCT07149506

CEI-038-2025

CI/HRAEB/024/2025 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 162 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histopathologically confirmed diagnosis of cancer.

• Complete blood count, blood chemistry, and liver function tests within normal ranges.

• Availability of an anatomopathological report.

• Aged between 18 and 75 years.

• Karnofsky performance status (KPS) score > 60 or an Eastern Cooperative Oncology Group (ECOG) performance status score < 3.

• Candidate for radiotherapy with a prescribed dose of ≥40 Gy or its biological equivalent (EQD2).

• Must provide written informed consent to participate in the study.

• Must be able to swallow capsules.

• Must meet one of the following cohort-specific criteria:

  1. Prevention cohort: No clinical evidence of dermatitis at the initiation of radiotherapy.
  2. Treatment cohort: Development of grade 1 dermatitis during radiotherapy, with symptom onset within the last 3 days.

Exclusion criteria

• Pregnant or lactating.
• Immunocompromised or on chronic therapy with immunosuppressive or immunomodulatory medications.
• History of chemical burns or unhealed wounds in the intended radiotherapy treatment area.
• Current diagnosis of skin cancer or a known diagnosis of a DNA repair gene defect.
• Prior radiotherapy to the area currently being treated.
• Known allergy to any of the study compounds.
• Currently receiving treatment with bortezomib, sunitinib, ticagrelor, or other antithrombotic agents.

Withdrawal Criteria:

• Adherence to the study intervention is less than 80%.
• Withdrawal of consent.
• Suspension of their radiotherapy sessions secondary to an acute infectious disease or the need for hospitalization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

162 participants in 8 patient groups, including a placebo group

Oral epicatechin prevention group

Experimental group

Description:

Oral epicatechin at a dose of 50 mg orally every 12 hours, starting from the start of radiotherapy, considering that one dose should be taken 2.5 hours before radiotherapy.

Treatment:

Other: Epicatechin

Oral placebo prevention group

Placebo Comparator group

Description:

Microcrystalline cellulose at a dose of 50 mg orally every 12 hours, starting from the start of radiotherapy, considering that one dose should be taken 2.5 hours before radiotherapy.

Treatment:

Other: Microcrystalline Cellulose NF (placebo)

Topical epigallocatechin-3 gallate (EGCG) prevention group

Experimental group

Description:

EGCG 660 μmol/L solution will be applied 0.5mL/cm2, 3 times a day in the treatment area from the start of radiotherapy and up to 2 weeks after the end of radiotherapy.

Treatment:

Other: Epigallocatechin Gallate (EGCG)

Topical placebo prevention group

Placebo Comparator group

Description:

Application of 0.5 mL/cm2 of 0.9% saline solution to the treatment area, three times per day. This regimen should be followed from the onset of radiotherapy until two weeks post-radiotherapy.

Treatment:

Other: Saline (0.9% NaCl)

Oral epicatechin treatment group

Experimental group

Description:

Oral epicatechin at a dose of 50 mg orally every 12 hours from the development of grade 1 radiodermatitis, considering that one should be taken 2.5 hours before radiotherapy.

Treatment:

Other: Epicatechin

Oral placebo treatment group

Placebo Comparator group

Description:

Microcrystalline cellulose at a dose of 50 mg orally every 12 hours, starting from the development of grade 1 radiodermatitis, considering that a dose should be taken 2.5 hours before radiotherapy.

Treatment:

Other: Microcrystalline Cellulose NF (placebo)

Topical EGCG treatment group

Experimental group

Description:

A solution of epigallocatechin-3 gallate (EGCG) 660 μmol/L, 0.5 mL/cm2, will be applied 3 times a day to the area to be treated from the development of grade 1 radiodermatitis and up to 2 weeks after the end of radiotherapy.

Treatment:

Other: Epigallocatechin Gallate (EGCG)

Topical placebo treatment group

Placebo Comparator group

Description:

Application of 0.5 mL/cm2 of 0.9% saline solution to the treatment area, three times per day. This regimen should be followed from the development of grade 1 radiodermatitis until two weeks post-radiotherapy.

Treatment:

Other: Saline (0.9% NaCl)