Radiation Dermatitis AcutePhase 3OCTOPUS-RDNCT07149506

Oral or Topical Catechins for Radiation Dermatitis

A Phase 3 study testing Epicatechin, Epigallocatechin Gallate (EGCG) and Saline (0.9% NaCl) in people with Radiation Dermatitis Acute and Radiation Dermatitis, run by CARLOS FRANCISCO SAAVEDRA GARCIA at 1 site in Mexico.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Radiation Dermatitis Acute, Radiation Dermatitis, Fibrosis; Skin
What is being tested?: Epicatechin, Epigallocatechin Gallate (EGCG) and Saline (0.9% NaCl)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 162 participants
Where: 1 siteMexico
Study dates: 1 Oct 2026to 1 Mar 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Show all 11Show fewer

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

Who cannot join

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.

Show all 11Show fewer

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mexico1 site

HRAEB
León, Guanajuato, 37544

Other trials in Mexico

About this study

Official title: 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

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
Being tested: Epicatechin, Epigallocatechin Gallate (EGCG), Microcrystalline Cellulose NF (placebo), Saline (0.9% NaCl)
Keywords: Catechins, Radiation Dermatitis
Medical subject headings: Radiodermatitis, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EpicatechinOther
A comparison will be made between oral catechin (epicatechin) from two approaches: a preventive approach and a therapeutic approach.
Epigallocatechin Gallate (EGCG)Other
Also called Epigallocatechin-3 Gallate
A comparison will be made between topical catechin (EGCG) from two approaches: a preventive approach and a therapeutic approach.
Microcrystalline Cellulose NF (placebo)Other
Also called Placebo
A comparison will be made between oral placebo (microcrystalline cellulose) from two approaches: a preventive approach and a therapeutic approach.
Saline (0.9% NaCl)Other
Also called Placebo
A comparison will be made between topical placebo (0.9% saline solution) from two approaches: a preventive approach and a therapeutic approach.

Study groups in NCT07149506
Study group	Role	What they receive
Oral epicatechin prevention group	Experimental	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. Receives: Other: Epicatechin
Oral placebo prevention group	Placebo comparator	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. Receives: Other: Microcrystalline Cellulose NF (placebo)
Topical epigallocatechin-3 gallate (EGCG) prevention group	Experimental	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. Receives: Other: Epigallocatechin Gallate (EGCG)
Topical placebo prevention group	Placebo comparator	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. Receives: Other: Saline (0.9% NaCl)
Oral epicatechin treatment group	Experimental	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. Receives: Other: Epicatechin
Oral placebo treatment group	Placebo comparator	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. Receives: Other: Microcrystalline Cellulose NF (placebo)
Topical EGCG treatment group	Experimental	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. Receives: Other: Epigallocatechin Gallate (EGCG)
Topical placebo treatment group	Placebo comparator	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. Receives: Other: Saline (0.9% NaCl)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the incidence of chronic radiation fibrosis
Chronic radiation dermatitis/fibrosis This condition is defined as an adverse skin reaction that occurs more than 90 days after the start of radiotherapy. It involves permanent structural changes to the skin, such as fibrosis and vascular atrophy. Fibrosis can increase the risk of poor wound healing, skin contractures, and pain.
Radiation therapy oncology group (RTOG) scale The RTOG scale is a standardized tool used to grade late-stage radiation effects. For the purposes of this study, the presence of fibrosis is graded on an ordinal scale with a minimum value of 0 and a maximum value of 2. On this scale, a higher score indicates a worse outcome (more severe fibrosis).
Measured: A baseline RTOG scale evaluation is performed before the placebo or catechins treatment begins. Following treatment, primary measurements for fibrosis are taken during follow-up visits at 3 and 6 months post-radiotherapy.
Change in the radiation-induced skin reaction assessment scale (RISRAS) score
The Radiation-Induced Skin Reaction Assessment Scale (RISRAS) measures the severity of skin reactions to radiotherapy. It combines a clinician's assessment of visible signs with the patient's self-reported symptoms. A higher score, with a maximum of 37.5 points, indicates a more severe reaction.
Clinicians apply the RISRAS scale to assess the the severity of acute radiation dermatitis.
The change from baseline will be compared between the catechin and placebo groups to determine the impact on symptom severity.
Measured: A baseline RISRAS scale evaluation is performed before the placebo or catechins treatment begins. Subsequent measurements are then taken up to week 7 during radiotherapy, and at 1 week and 2 weeks post-radiotherapy.

Secondary outcomes (6)

Incidence of Adverse Events
Outcome Measure Description:
The frequency of adverse events, such as hepatic or hematological toxicity, will be quantified and compared between the catechin and placebo groups.
Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used as the standardized system for grading the severity of acute adverse events. For this study, the events will be graded on its 5-point scale, ranging from a minimum of Grade 1 (mild) to a maximum of Grade 5 (death related to the adverse event). A higher score on this scale indicates a worse outcome.
Measured: A baseline CTCAE v5.0 scale evaluation is performed before the placebo or catechins treatment begins. Subsequent evaluations are then conducted up to week 7 during radiotherapy and again at 3 months post-radiotherapy.
Dermatological Quality of Life
Outcome Measure Description:
The skin-related quality of life (QoL) will be determined and compared among patients in the different treatment groups. It will be evaluated using the Skindex-16 questionnaire, a validated 16-item tool that measures skin-specific QoL across three domains: symptoms, emotions, and functioning. The questionnaire has a minimum score of 0 and a maximum score of 100. On this scale, a higher score indicates a worse QoL.
Measured: The measurement will be taken at baseline (before the placebo or catechins treatment begins), weekly up to week 7 during radiotherapy, and at 3 and 6 months post-radiotherapy.
Cumulative radiation dose at onset of grade ≥2 dermatitis
The total radiation dose (in Gray - Gy) delivered to the skin at the precise moment the first clinical signs of grade 2 (or higher) radiation dermatitis are observed, as assessed by the radiation-induced skin reaction assessment scale (RISRAS).
Interpretation: A higher cumulative dose (Gy) indicates a better outcome. It signifies greater radioprotection from the intervention, allowing the patient to tolerate more radiotherapy before experiencing significant skin toxicity.
Unit of measure: Gray (Gy).
Measured: Measurements are taken throughout radiotherapy, up to week 7, with additional assessments at 1 and 2 weeks after the radiotherapy period.
Cosmetic Outcome
The cosmetic results of the skin in the treated area will be evaluated. This will be measured objectively using serial photographs. The photographs will be analyzed quantitatively with ImageJ software (National Institutes of Health, Bethesda, MD) to measure and compare changes in skin appearance (e.g., erythema, pigmentation, texture) between the catechin and placebo groups.
Interpretation of results:
Objective quantitative analysis: A statistically significant improvement in the quantitative skin appearance metrics (e.g., reduced erythema, improved homogeneity) in the catechin group compared to the placebo group at the post-radiotherapy time points indicates a better cosmetic outcome.
A lack of significant difference or worse metrics in the catechin group would indicate no benefit or a worse outcome, respectively.
Measured: Photographs will be taken at three key points: Baseline, before the placebo or catechins treatment begins. During radiotherapy, specifically at weeks 1 and 3 of treatment. Post-radiotherapy, at both 3 and 6 months after treatment.
Duration of grade ≥2 dermatitis
The length of time (in days) that the radiation dermatitis persists at a severity of Grade 2 or higher, from its onset until its resolution to grade 1 or lower, as measured by the radiation-induced skin reaction assessment scale (RISRAS).
Interpretation: A shorter duration (fewer days) indicates a better outcome. It signifies a faster recovery and resolution of the skin adverse event, potentially improving patient quality of life and reducing treatment interruptions.
Unit of measure: Days.
Measured: Measurements are taken throughout radiotherapy, up to week 7, with additional assessments at 1 and 2 weeks after the radiotherapy period.
Percentage of Affected Skin Area by Radiation Dermatitis
Standardized photographs of the irradiated area will be taken and analyzed using ImageJ® software to objectively quantify the percentage of skin affected by dermatitis. This objective measurement will be compared between the catechin and placebo groups.
Unit of measure: Percentage (%).
A higher percentage of affected skin indicates a more severe cutaneous reaction to radiation, while a lower percentage suggests a better clinical outcome and greater radioprotection.
Measured: Baseline, week 1, and week 3 of radiotherapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20261 Mar 2027

First posted2 Sep 2025
Study start1 Oct 2026 (estimated)
Primary completion1 Oct 2026 (estimated)
Study completion1 Mar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (112)Papers the sponsor has linked to this study.
Other trials for Radiation Dermatitis AcuteStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 162 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07149506
Sponsor's protocol ID: CEI-038-2025
Other IDs: CI/HRAEB/024/2025
Acronym: OCTOPUS-RD
Status last verified: Sep 2026
First submitted: 6 Aug 2025
Last updated: 11 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Only IPD used in the results publication

Publications

Chacko SM, Thambi PT, Kuttan R, Nishigaki I. Beneficial effects of green tea: a literature review. Chin Med. 2010 Apr 6;5:13. doi: 10.1186/1749-8546-5-13.
PubMed 20370896
Ortiz J, Kestur US, Taylor LS, Mauer LJ. Interaction of environmental moisture with powdered green tea formulations: relationship between catechin stability and moisture-induced phase transformations. J Agric Food Chem. 2009 Jun 10;57(11):4691-7. doi: 10.1021/jf8038583.
PubMed 19489621
Moreno-Ulloa A , Najera-Garcia N , Hernandez M , Ramirez-Sanchez I , Taub PR , Su Y , Beltran-Partida E , Ceballos G , Dugar S , Schreiner G , Best BM , Ciaraldi TP , Henry RR , Villarreal F . A pilot study on clinical pharmacokinetics and preclinical pharmacodynamics of (+)-epicatechin on cardiometabolic endpoints. Food Funct. 2018 Jan 24;9(1):307-319. doi: 10.1039/c7fo01028a.
PubMed 29171848
Vollmann J, Winau R. Informed consent in human experimentation before the Nuremberg code. BMJ. 1996 Dec 7;313(7070):1445-9. doi: 10.1136/bmj.313.7070.1445.
PubMed 8973233
World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Participants. JAMA. 2025 Jan 7;333(1):71-74. doi: 10.1001/jama.2024.21972.
PubMed 39425955
Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: Updated guideline for reporting randomised trials. PLoS Med. 2025 Apr 14;22(4):e1004587. doi: 10.1371/journal.pmed.1004587. eCollection 2025 Apr.
PubMed 40228477
Wooding H, Yan J, Yuan L, Chyou TY, Gao S, Ward I, Herst PM. The effect of Mepitel Film on acute radiation-induced skin reactions in head and neck cancer patients: a feasibility study. Br J Radiol. 2018 Jan;91(1081):20170298. doi: 10.1259/bjr.20170298. Epub 2017 Nov 8.
PubMed 29072852
Robijns J, Censabella S, Claes S, Pannekoeke L, Busse L, Colson D, Kaminski I, Bulens P, Maes A, Noe L, Brosens M, Timmermans A, Lambrichts I, Somers V, Mebis J. Prevention of acute radiodermatitis by photobiomodulation: A randomized, placebo-controlled trial in breast cancer patients (TRANSDERMIS trial). Lasers Surg Med. 2018 Feb 10. doi: 10.1002/lsm.22804. Online ahead of print.
PubMed 29427390
Yu Z, Samavat H, Dostal AM, Wang R, Torkelson CJ, Yang CS, Butler LM, Kensler TW, Wu AH, Kurzer MS, Yuan JM. Effect of Green Tea Supplements on Liver Enzyme Elevation: Results from a Randomized Intervention Study in the United States. Cancer Prev Res (Phila). 2017 Oct;10(10):571-579. doi: 10.1158/1940-6207.CAPR-17-0160. Epub 2017 Aug 1.
PubMed 28765194
EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Younes M, Aggett P, Aguilar F, Crebelli R, Dusemund B, Filipic M, Frutos MJ, Galtier P, Gott D, Gundert-Remy U, Lambre C, Leblanc JC, Lillegaard IT, Moldeus P, Mortensen A, Oskarsson A, Stankovic I, Waalkens-Berendsen I, Woutersen RA, Andrade RJ, Fortes C, Mosesso P, Restani P, Arcella D, Pizzo F, Smeraldi C, Wright M. Scientific opinion on the safety of green tea catechins. EFSA J. 2018 Apr 18;16(4):e05239. doi: 10.2903/j.efsa.2018.5239. eCollection 2018 Apr.
PubMed 32625874
Zhao H, Zhu W, Jia L, Sun X, Chen G, Zhao X, Li X, Meng X, Kong L, Xing L, Yu J. Phase I study of topical epigallocatechin-3-gallate (EGCG) in patients with breast cancer receiving adjuvant radiotherapy. Br J Radiol. 2016;89(1058):20150665. doi: 10.1259/bjr.20150665. Epub 2015 Nov 26.
PubMed 26607642
Zhu W, Jia L, Chen G, Zhao H, Sun X, Meng X, Zhao X, Xing L, Yu J, Zheng M. Epigallocatechin-3-gallate ameliorates radiation-induced acute skin damage in breast cancer patients undergoing adjuvant radiotherapy. Oncotarget. 2016 Jul 26;7(30):48607-48613. doi: 10.18632/oncotarget.9495.
PubMed 27224910
Landis-Piwowar K, Chen D, Foldes R, Chan TH, Dou QP. Novel epigallocatechin gallate analogs as potential anticancer agents: a patent review (2009 - present). Expert Opin Ther Pat. 2013 Feb;23(2):189-202. doi: 10.1517/13543776.2013.743993. Epub 2012 Dec 12.
PubMed 23230990
Xu FW, Lv YL, Zhong YF, Xue YN, Wang Y, Zhang LY, Hu X, Tan WQ. Beneficial Effects of Green Tea EGCG on Skin Wound Healing: A Comprehensive Review. Molecules. 2021 Oct 11;26(20):6123. doi: 10.3390/molecules26206123.
PubMed 34684703
Hwang Y, Chang B, Kim T, Kim S. Ameliorative effects of green tea extract from tannase digests on house dust mite antigen-induced atopic dermatitis-like lesions in NC/Nga mice. Arch Dermatol Res. 2019 Mar;311(2):109-120. doi: 10.1007/s00403-018-01886-6. Epub 2019 Jan 7.
PubMed 30617657

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 2
Superoxide Dismutase Skin Spray for the Prevention of Acute Radiation Dermatitis in Head and Neck Cancer
Radiation-induced Dermatitis
RecruitingEarly Phase 1
Adapalene Gel for Acute Radiation-Induced Skin Injury
Radiation Dermatitis
RecruitingPhase 1
Using Silverlon® for Head and Neck Patients With Tracheostomies
Head and Neck Cancer, Radiation Dermatitis Acute
RecruitingPhase 1
Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury
Radiation-Induced Skin Injury
Active, not recruitingPhase 1
Comparing Supplemental Topical Agents for the Treatment of Acute Radiation Dermatitis in Patients With Breast Cancer
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma

All Radiation Dermatitis Acute trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07149506
Acronym / sponsor ID: OCTOPUS-RD / CEI-038-2025
Conditions: Radiation Dermatitis Acute, Radiation Dermatitis, Fibrosis; Skin
Keywords: Catechins, Radiation Dermatitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 162 participants (estimated)
Lead sponsor: CARLOS FRANCISCO SAAVEDRA GARCIAUniversity, hospital or other
Collaborators: Universidad de Guanajuato, Hospital Regional de Alta Especialidad del Bajio
Study start: 1 Oct 2026 (estimated)
Primary completion: 1 Oct 2026 (estimated)
Study completion: 1 Mar 2027 (estimated)
First posted: 2 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Material and Methods

Epigallocatechin gallate (experimental aerosol)

Epicatechin (experimental capsule)

Saline control arm (aerosol)

Microcrystalline cellulose excipient control arm (capsule)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Oral epicatechin prevention group	Experimental	Other: EpicatechinOral 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.
Oral placebo prevention group	Placebo comparator	Other: Microcrystalline Cellulose NF (placebo)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.
Topical epigallocatechin-3 gallate (EGCG) prevention group	Experimental	Other: Epigallocatechin Gallate (EGCG)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.
Topical placebo prevention group	Placebo comparator	Other: Saline (0.9% NaCl)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.
Oral epicatechin treatment group	Experimental	Other: EpicatechinOral 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.
Oral placebo treatment group	Placebo comparator	Other: Microcrystalline Cellulose NF (placebo)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.
Topical EGCG treatment group	Experimental	Other: Epigallocatechin Gallate (EGCG)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.
Topical placebo treatment group	Placebo comparator	Other: Saline (0.9% NaCl)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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EpicatechinA comparison will be made between oral catechin (epicatechin) from two approaches: a preventive approach and a therapeutic approach.	Other	Oral epicatechin prevention group, Oral epicatechin treatment group
Epigallocatechin Gallate (EGCG)Also: Epigallocatechin-3 GallateA comparison will be made between topical catechin (EGCG) from two approaches: a preventive approach and a therapeutic approach.	Other	Topical EGCG treatment group, Topical epigallocatechin-3 gallate (EGCG) prevention group
Microcrystalline Cellulose NF (placebo)Also: PlaceboA comparison will be made between oral placebo (microcrystalline cellulose) from two approaches: a preventive approach and a therapeutic approach.	Other	Oral placebo prevention group, Oral placebo treatment group
Saline (0.9% NaCl)Also: PlaceboA comparison will be made between topical placebo (0.9% saline solution) from two approaches: a preventive approach and a therapeutic approach.	Other	Topical placebo prevention group, Topical placebo treatment group

Primary outcome

Change in the incidence of chronic radiation fibrosis
Time frame: A baseline RTOG scale evaluation is performed before the placebo or catechins treatment begins. Following treatment, primary measurements for fibrosis are taken during follow-up visits at 3 and 6 months post-radiotherapy.
Chronic radiation dermatitis/fibrosis This condition is defined as an adverse skin reaction that occurs more than 90 days after the start of radiotherapy. It involves permanent structural changes to the skin, such as fibrosis and vascular atrophy. Fibrosis can increase the risk of poor wound healing, skin contractures, and pain. Radiation therapy oncology group (RTOG) scale The RTOG scale is a standardized tool used to grade late-stage radiation effects. For the purposes of this study, the presence of fibrosis is graded on an ordinal scale with a minimum value of 0 and a maximum value of 2. On this scale, a higher score indicates a worse outcome (more severe fibrosis).
Change in the radiation-induced skin reaction assessment scale (RISRAS) score
Time frame: A baseline RISRAS scale evaluation is performed before the placebo or catechins treatment begins. Subsequent measurements are then taken up to week 7 during radiotherapy, and at 1 week and 2 weeks post-radiotherapy.
The Radiation-Induced Skin Reaction Assessment Scale (RISRAS) measures the severity of skin reactions to radiotherapy. It combines a clinician's assessment of visible signs with the patient's self-reported symptoms. A higher score, with a maximum of 37.5 points, indicates a more severe reaction. Clinicians apply the RISRAS scale to assess the the severity of acute radiation dermatitis. The change from baseline will be compared between the catechin and placebo groups to determine the impact on symptom severity.

6 secondary outcomes

Incidence of Adverse Events
Time frame: A baseline CTCAE v5.0 scale evaluation is performed before the placebo or catechins treatment begins. Subsequent evaluations are then conducted up to week 7 during radiotherapy and again at 3 months post-radiotherapy.
Dermatological Quality of Life
Time frame: The measurement will be taken at baseline (before the placebo or catechins treatment begins), weekly up to week 7 during radiotherapy, and at 3 and 6 months post-radiotherapy.
Cumulative radiation dose at onset of grade ≥2 dermatitis
Time frame: Measurements are taken throughout radiotherapy, up to week 7, with additional assessments at 1 and 2 weeks after the radiotherapy period.
Cosmetic Outcome
Time frame: Photographs will be taken at three key points: Baseline, before the placebo or catechins treatment begins. During radiotherapy, specifically at weeks 1 and 3 of treatment. Post-radiotherapy, at both 3 and 6 months after treatment.
Duration of grade ≥2 dermatitis
Time frame: Measurements are taken throughout radiotherapy, up to week 7, with additional assessments at 1 and 2 weeks after the radiotherapy period.
Percentage of Affected Skin Area by Radiation Dermatitis
Time frame: Baseline, week 1, and week 3 of radiotherapy.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
Background: PubMed 20370896Chacko SM, Thambi PT, Kuttan R, Nishigaki I. Beneficial effects of green tea: a literature review. Chin Med. 2010 Apr 6;5:13. doi: 10.1186/1749-8546-5-13.
Background: PubMed 19489621Ortiz J, Kestur US, Taylor LS, Mauer LJ. Interaction of environmental moisture with powdered green tea formulations: relationship between catechin stability and moisture-induced phase transformations. J Agric Food Chem. 2009 Jun 10;57(11):4691-7. doi: 10.1021/jf8038583.
Background: PubMed 29171848Moreno-Ulloa A , Najera-Garcia N , Hernandez M , Ramirez-Sanchez I , Taub PR , Su Y , Beltran-Partida E , Ceballos G , Dugar S , Schreiner G , Best BM , Ciaraldi TP , Henry RR , Villarreal F . A pilot study on clinical pharmacokinetics and preclinical pharmacodynamics of (+)-epicatechin on cardiometabolic endpoints. Food Funct. 2018 Jan 24;9(1):307-319. doi: 10.1039/c7fo01028a.
Background: PubMed 8973233Vollmann J, Winau R. Informed consent in human experimentation before the Nuremberg code. BMJ. 1996 Dec 7;313(7070):1445-9. doi: 10.1136/bmj.313.7070.1445.
Background: PubMed 39425955World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Participants. JAMA. 2025 Jan 7;333(1):71-74. doi: 10.1001/jama.2024.21972.
Background: PubMed 40228477Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: Updated guideline for reporting randomised trials. PLoS Med. 2025 Apr 14;22(4):e1004587. doi: 10.1371/journal.pmed.1004587. eCollection 2025 Apr.
Background: PubMed 29072852Wooding H, Yan J, Yuan L, Chyou TY, Gao S, Ward I, Herst PM. The effect of Mepitel Film on acute radiation-induced skin reactions in head and neck cancer patients: a feasibility study. Br J Radiol. 2018 Jan;91(1081):20170298. doi: 10.1259/bjr.20170298. Epub 2017 Nov 8.
Background: PubMed 29427390Robijns J, Censabella S, Claes S, Pannekoeke L, Busse L, Colson D, Kaminski I, Bulens P, Maes A, Noe L, Brosens M, Timmermans A, Lambrichts I, Somers V, Mebis J. Prevention of acute radiodermatitis by photobiomodulation: A randomized, placebo-controlled trial in breast cancer patients (TRANSDERMIS trial). Lasers Surg Med. 2018 Feb 10. doi: 10.1002/lsm.22804. Online ahead of print.
Background: PubMed 28765194Yu Z, Samavat H, Dostal AM, Wang R, Torkelson CJ, Yang CS, Butler LM, Kensler TW, Wu AH, Kurzer MS, Yuan JM. Effect of Green Tea Supplements on Liver Enzyme Elevation: Results from a Randomized Intervention Study in the United States. Cancer Prev Res (Phila). 2017 Oct;10(10):571-579. doi: 10.1158/1940-6207.CAPR-17-0160. Epub 2017 Aug 1.
Background: PubMed 32625874EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Younes M, Aggett P, Aguilar F, Crebelli R, Dusemund B, Filipic M, Frutos MJ, Galtier P, Gott D, Gundert-Remy U, Lambre C, Leblanc JC, Lillegaard IT, Moldeus P, Mortensen A, Oskarsson A, Stankovic I, Waalkens-Berendsen I, Woutersen RA, Andrade RJ, Fortes C, Mosesso P, Restani P, Arcella D, Pizzo F, Smeraldi C, Wright M. Scientific opinion on the safety of green tea catechins. EFSA J. 2018 Apr 18;16(4):e05239. doi: 10.2903/j.efsa.2018.5239. eCollection 2018 Apr.
Background: PubMed 26607642Zhao H, Zhu W, Jia L, Sun X, Chen G, Zhao X, Li X, Meng X, Kong L, Xing L, Yu J. Phase I study of topical epigallocatechin-3-gallate (EGCG) in patients with breast cancer receiving adjuvant radiotherapy. Br J Radiol. 2016;89(1058):20150665. doi: 10.1259/bjr.20150665. Epub 2015 Nov 26.
Background: PubMed 27224910Zhu W, Jia L, Chen G, Zhao H, Sun X, Meng X, Zhao X, Xing L, Yu J, Zheng M. Epigallocatechin-3-gallate ameliorates radiation-induced acute skin damage in breast cancer patients undergoing adjuvant radiotherapy. Oncotarget. 2016 Jul 26;7(30):48607-48613. doi: 10.18632/oncotarget.9495.
Individual participant dataSharing planned: Yes. Only IPD used in the results publication

Related trials for Radiation Dermatitis Acute

RecruitingPhase 2
Superoxide Dismutase Skin Spray for the Prevention of Acute Radiation Dermatitis in Head and Neck Cancer
Radiation-induced Dermatitis
RecruitingEarly Phase 1
Adapalene Gel for Acute Radiation-Induced Skin Injury
Radiation Dermatitis
RecruitingPhase 1
Using Silverlon® for Head and Neck Patients With Tracheostomies
Head and Neck Cancer, Radiation Dermatitis Acute
RecruitingPhase 1
Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury
Radiation-Induced Skin Injury
Active, not recruitingPhase 1
Comparing Supplemental Topical Agents for the Treatment of Acute Radiation Dermatitis in Patients With Breast Cancer
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Carmen Palacios, MD; PhD; MMSc; genetics study director

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the incidence of chronic radiation fibrosis (time frame: A baseline RTOG scale evaluation is performed before the placebo or catechins treatment begins. Following treatment, primary measurements for fibrosis are taken during follow-up visits at 3 and 6 months post-radiotherapy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07149506, which also lists 112 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.