Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
ENROLLING_BY_INVITATION
Clinical Phase
PHASE3
Total Enrollment
162 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-09-01
Study Completion Date
2027-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Topically Applied Green Tea Extract for Radio Dermatitis and Radiation Mucositis
NCT01481818
Epigallocatechin Gallate
Radio Dermatitis
Radiation Mucositis
UNKNOWN
PHASE1/PHASE2
Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy
NCT05994638
Oral Mucositis
UNKNOWN
NA
The Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients
NCT01099891
Stomatitis
UNKNOWN
PHASE3
Capsaicin Lozenges in Treating Patients With Mucositis Caused by Radiation Therapy
NCT00003610
Head and Neck Cancer
Radiation Toxicity
COMPLETED
PHASE3
Topical Diclofenac for Prevention of Radiation-induced Dermatitis
NCT06905561
Head and Neck Tumor
Breast Cancer
RECRUITING
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Radiation Dermatitis Acute
Radiation Dermatitis
Fibrosis; Skin
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Oral epicatechin prevention group
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.
Group Type
EXPERIMENTAL
Epicatechin
Intervention Type
OTHER
A comparison will be made between oral catechin (epicatechin) from two approaches: a preventive approach and a therapeutic approach.
Oral placebo prevention group
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.
Group Type
PLACEBO_COMPARATOR
Microcrystalline Cellulose NF (placebo)
Intervention Type
OTHER
A comparison will be made between oral placebo (microcrystalline cellulose) from two approaches: a preventive approach and a therapeutic approach.
Topical epigallocatechin-3 gallate (EGCG) prevention group
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.
Group Type
EXPERIMENTAL
Epigallocatechin Gallate (EGCG)
Intervention Type
OTHER
A comparison will be made between topical catechin (EGCG) from two approaches: a preventive approach and a therapeutic approach.
Topical placebo prevention group
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.
Group Type
PLACEBO_COMPARATOR
Saline (0.9% NaCl)
Intervention Type
OTHER
A comparison will be made between topical placebo (0.9% saline solution) from two approaches: a preventive approach and a therapeutic approach.
Oral epicatechin treatment group
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.
Group Type
EXPERIMENTAL
Epicatechin
Intervention Type
OTHER
A comparison will be made between oral catechin (epicatechin) from two approaches: a preventive approach and a therapeutic approach.
Oral placebo treatment group
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.
Group Type
PLACEBO_COMPARATOR
Microcrystalline Cellulose NF (placebo)
Intervention Type
OTHER
A comparison will be made between oral placebo (microcrystalline cellulose) from two approaches: a preventive approach and a therapeutic approach.
Topical EGCG treatment group
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.
Group Type
EXPERIMENTAL
Epigallocatechin Gallate (EGCG)
Intervention Type
OTHER
A comparison will be made between topical catechin (EGCG) from two approaches: a preventive approach and a therapeutic approach.
Topical placebo treatment group
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.
Group Type
PLACEBO_COMPARATOR
Saline (0.9% NaCl)
Intervention Type
OTHER
A comparison will be made between topical placebo (0.9% saline solution) from two approaches: a preventive approach and a therapeutic approach.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Epicatechin
A comparison will be made between oral catechin (epicatechin) from two approaches: a preventive approach and a therapeutic approach.
Intervention Type
OTHER
Epigallocatechin Gallate (EGCG)
A comparison will be made between topical catechin (EGCG) from two approaches: a preventive approach and a therapeutic approach.
Intervention Type
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.
Intervention Type
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.
Intervention Type
OTHER
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Epigallocatechin-3 Gallate
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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.
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad de Guanajuato
OTHER
Sponsor Role
collaborator
Hospital Regional de Alta Especialidad del Bajio
OTHER
Sponsor Role
collaborator
CARLOS FRANCISCO SAAVEDRA GARCIA
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
CARLOS FRANCISCO SAAVEDRA GARCIA
Principal Investigator
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carmen Palacios, MD; PhD; MMSc; genetics
Role: STUDY_DIRECTOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
HRAEB
León, Guanajuato, Mexico
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Mexico
References
Explore related publications, articles, or registry entries linked to this study.
Rey JL, Felix H, De Bary JB, Haller L. Ceftriaxone for treatment of severe infections in peripheral health centers in Africa. Chemioterapia. 1987 Jun;6(2 Suppl):382-3. No abstract available.
Reference Type
BACKGROUND
Masek P, Winklerova S. [Fluorescein and its adverse effects]. Cesk Oftalmol. 1989 Sep;45(5):362-4. Czech.
Reference Type
BACKGROUND
Fraser IE. Proteins of keratin and their synthesis. II. Incorporation of [35S]cystine into prekeratin and keratin proteins. Aust J Biol Sci. 1969 Feb;22(1):231-8. No abstract available.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Chamcheu JC, Siddiqui IA, Adhami VM, Esnault S, Bharali DJ, Babatunde AS, Adame S, Massey RJ, Wood GS, Longley BJ, Mousa SA, Mukhtar H. Chitosan-based nanoformulated (-)-epigallocatechin-3-gallate (EGCG) modulates human keratinocyte-induced responses and alleviates imiquimod-induced murine psoriasiform dermatitis. Int J Nanomedicine. 2018 Jul 20;13:4189-4206. doi: 10.2147/IJN.S165966. eCollection 2018.
Reference Type
BACKGROUND
Wang ZT, Xue Y, Sun H, Zhang Z, Tang ZJ, Liu SB, Cai WM. Effect of tea polyphenols on the oral and intravenous pharmacokinetics of ticagrelor in rats and its in vitro metabolism. J Food Sci. 2020 Apr;85(4):1285-1291. doi: 10.1111/1750-3841.15096. Epub 2020 Mar 10.
Reference Type
BACKGROUND
Ge J, Tan BX, Chen Y, Yang L, Peng XC, Li HZ, Lin HJ, Zhao Y, Wei M, Cheng K, Li LH, Dong H, Gao F, He JP, Wu Y, Qiu M, Zhao YL, Su JM, Hou JM, Liu JY. Interaction of green tea polyphenol epigallocatechin-3-gallate with sunitinib: potential risk of diminished sunitinib bioavailability. J Mol Med (Berl). 2011 Jun;89(6):595-602. doi: 10.1007/s00109-011-0737-3. Epub 2011 Feb 18.
Reference Type
BACKGROUND
Golden EB, Lam PY, Kardosh A, Gaffney KJ, Cadenas E, Louie SG, Petasis NA, Chen TC, Schonthal AH. Green tea polyphenols block the anticancer effects of bortezomib and other boronic acid-based proteasome inhibitors. Blood. 2009 Jun 4;113(23):5927-37. doi: 10.1182/blood-2008-07-171389. Epub 2009 Feb 3.
Reference Type
BACKGROUND
Yen C, Zhao F, Yu Z, Zhu X, Li CG. Interactions Between Natural Products and Tamoxifen in Breast Cancer: A Comprehensive Literature Review. Front Pharmacol. 2022 Jun 2;13:847113. doi: 10.3389/fphar.2022.847113. eCollection 2022.
Reference Type
BACKGROUND
Esmaeili MA. Combination of siRNA-directed gene silencing with epigallocatechin-3-gallate (EGCG) reverses drug resistance in human breast cancer cells. J Chem Biol. 2015 Aug 8;9(1):41-52. doi: 10.1007/s12154-015-0144-2. eCollection 2016 Jan.
Reference Type
BACKGROUND
La X, Zhang L, Li Z, Li H, Yang Y. (-)-Epigallocatechin Gallate (EGCG) Enhances the Sensitivity of Colorectal Cancer Cells to 5-FU by Inhibiting GRP78/NF-kappaB/miR-155-5p/MDR1 Pathway. J Agric Food Chem. 2019 Mar 6;67(9):2510-2518. doi: 10.1021/acs.jafc.8b06665. Epub 2019 Feb 20.
Reference Type
BACKGROUND
Chang CM, Chang PY, Tu MG, Lu CC, Kuo SC, Amagaya S, Lee CY, Jao HY, Chen MY, Yang JS. Epigallocatechin gallate sensitizes CAL-27 human oral squamous cell carcinoma cells to the anti-metastatic effects of gefitinib (Iressa) via synergistic suppression of epidermal growth factor receptor and matrix metalloproteinase-2. Oncol Rep. 2012 Nov;28(5):1799-807. doi: 10.3892/or.2012.1991. Epub 2012 Aug 24.
Reference Type
BACKGROUND
Zhou H, Fu LX, Li L, Chen YY, Zhu HQ, Zhou JL, Lv MX, Gan RZ, Zhang XX, Liang G. The epigallocatechin gallate derivative Y6 reduces the cardiotoxicity and enhances the efficacy of daunorubicin against human hepatocellular carcinoma by inhibiting carbonyl reductase 1 expression. J Ethnopharmacol. 2020 Oct 28;261:113118. doi: 10.1016/j.jep.2020.113118. Epub 2020 Jul 1.
Reference Type
BACKGROUND
Lang M, Henson R, Braconi C, Patel T. Epigallocatechin-gallate modulates chemotherapy-induced apoptosis in human cholangiocarcinoma cells. Liver Int. 2009 May;29(5):670-7. doi: 10.1111/j.1478-3231.2009.01984.x. Epub 2009 Feb 17.
Reference Type
BACKGROUND
Shervington A, Pawar V, Menon S, Thakkar D, Patel R. The sensitization of glioma cells to cisplatin and tamoxifen by the use of catechin. Mol Biol Rep. 2009 May;36(5):1181-6. doi: 10.1007/s11033-008-9295-3. Epub 2008 Jun 26.
Reference Type
BACKGROUND
Lee TC, Cheng IC, Shue JJ, Wang TC. Cytotoxicity of arsenic trioxide is enhanced by (-)-epigallocatechin-3-gallate via suppression of ferritin in cancer cells. Toxicol Appl Pharmacol. 2011 Jan 1;250(1):69-77. doi: 10.1016/j.taap.2010.10.005. Epub 2010 Oct 13.
Reference Type
BACKGROUND
Sanchez Y, Calle C, de Blas E, Aller P. Modulation of arsenic trioxide-induced apoptosis by genistein and functionally related agents in U937 human leukaemia cells. Regulation by ROS and mitogen-activated protein kinases. Chem Biol Interact. 2009 Nov 10;182(1):37-44. doi: 10.1016/j.cbi.2009.08.015. Epub 2009 Aug 29.
Reference Type
BACKGROUND
Wang L, Li P, Feng K. EGCG adjuvant chemotherapy: Current status and future perspectives. Eur J Med Chem. 2023 Mar 15;250:115197. doi: 10.1016/j.ejmech.2023.115197. Epub 2023 Feb 10.
Reference Type
BACKGROUND
Zhao H, Zhu W, Xie P, Li H, Zhang X, Sun X, Yu J, Xing L. A phase I study of concurrent chemotherapy and thoracic radiotherapy with oral epigallocatechin-3-gallate protection in patients with locally advanced stage III non-small-cell lung cancer. Radiother Oncol. 2014 Jan;110(1):132-6. doi: 10.1016/j.radonc.2013.10.014. Epub 2014 Jan 17.
Reference Type
BACKGROUND
Shin DM, Nannapaneni S, Patel MR, Shi Q, Liu Y, Chen Z, Chen AY, El-Deiry MW, Beitler JJ, Steuer CE, Roser SM, Klein AM, Owonikoko TK, Ramalingam SS, Khuri FR, Chen ZG, Saba NF. Phase Ib Study of Chemoprevention with Green Tea Polyphenon E and Erlotinib in Patients with Advanced Premalignant Lesions (APL) of the Head and Neck. Clin Cancer Res. 2020 Nov 15;26(22):5860-5868. doi: 10.1158/1078-0432.CCR-20-2276. Epub 2020 Sep 17.
Reference Type
BACKGROUND
Zhu W, Mei H, Jia L, Zhao H, Li X, Meng X, Zhao X, Xing L, Yu J. Epigallocatechin-3-gallate mouthwash protects mucosa from radiation-induced mucositis in head and neck cancer patients: a prospective, non-randomised, phase 1 trial. Invest New Drugs. 2020 Aug;38(4):1129-1136. doi: 10.1007/s10637-019-00871-8. Epub 2019 Nov 7.
Reference Type
BACKGROUND
Zhang G, Wang Y, Zhang Y, Wan X, Li J, Liu K, Wang F, Liu K, Liu Q, Yang C, Yu P, Huang Y, Wang S, Jiang P, Qu Z, Luan J, Duan H, Zhang L, Hou A, Jin S, Hsieh TC, Wu E. Anti-cancer activities of tea epigallocatechin-3-gallate in breast cancer patients under radiotherapy. Curr Mol Med. 2012 Feb;12(2):163-76. doi: 10.2174/156652412798889063.
Reference Type
BACKGROUND
Li X, Xing L, Zhang Y, Xie P, Zhu W, Meng X, Wang Y, Kong L, Zhao H, Yu J. Phase II Trial of Epigallocatechin-3-Gallate in Acute Radiation-Induced Esophagitis for Esophagus Cancer. J Med Food. 2020 Jan;23(1):43-49. doi: 10.1089/jmf.2019.4445. Epub 2019 Nov 20.
Reference Type
BACKGROUND
Zhao H, Xie P, Li X, Zhu W, Sun X, Sun X, Chen X, Xing L, Yu J. A prospective phase II trial of EGCG in treatment of acute radiation-induced esophagitis for stage III lung cancer. Radiother Oncol. 2015 Mar;114(3):351-6. doi: 10.1016/j.radonc.2015.02.014. Epub 2015 Mar 10.
Reference Type
BACKGROUND
Lu H, Xie L, Guo L, Gu X, Zhu R, Yang Y, Tang F, Li M, Liu C, Wang D, Li M, Tian Y, Cai S. EGCG protects intestines of mice and pelvic cancer patients against radiation injury via the gut microbiota/D-tagatose/AMPK axis. Radiother Oncol. 2025 Jan;202:110608. doi: 10.1016/j.radonc.2024.110608. Epub 2024 Oct 31.
Reference Type
BACKGROUND
Kang Y, Xiong Y, Lu B, Wang Y, Zhang D, Feng J, Chen L, Zhang Z. Application of In Situ Mucoadhesive Hydrogel with Anti-Inflammatory and Pro-Repairing Dual Properties for the Treatment of Chemotherapy-Induced Oral Mucositis. ACS Appl Mater Interfaces. 2024 Jul 17;16(28):35949-35963. doi: 10.1021/acsami.4c03217. Epub 2024 Jul 6.
Reference Type
BACKGROUND
Kapoor MP, Sugita M, Fukuzawa Y, Timm D, Ozeki M, Okubo T. Green Tea Catechin Association with Ultraviolet Radiation-Induced Erythema: A Systematic Review and Meta-Analysis. Molecules. 2021 Jun 17;26(12):3702. doi: 10.3390/molecules26123702.
Reference Type
BACKGROUND
Najera N, Ortiz-Flores M, Perez-Duran J, Reyes-Munoz E, Romo-Yanez J, Ortiz-Luna G, Villarreal F, Meaney E, Ceballos G, Montoya-Estrada A. Improving Cardiovascular Risk in Postmenopausal Women with an (-)-Epicatechin-Based Nutraceutical: A Randomly Assigned, Double-Blind vs. Placebo, Proof-of-Concept Trial. J Clin Med. 2023 Dec 29;13(1):195. doi: 10.3390/jcm13010195.
Reference Type
BACKGROUND
Gutierrez-Salmean G, Meaney E, Lanaspa MA, Cicerchi C, Johnson RJ, Dugar S, Taub P, Ramirez-Sanchez I, Villarreal F, Schreiner G, Ceballos G. A randomized, placebo-controlled, double-blind study on the effects of (-)-epicatechin on the triglyceride/HDLc ratio and cardiometabolic profile of subjects with hypertriglyceridemia: Unique in vitro effects. Int J Cardiol. 2016 Nov 15;223:500-506. doi: 10.1016/j.ijcard.2016.08.158. Epub 2016 Aug 8.
Reference Type
BACKGROUND
Zhao H, Zhu W, Zhao X, Li X, Zhou Z, Zheng M, Meng X, Kong L, Zhang S, He D, Xing L, Yu J. Efficacy of Epigallocatechin-3-Gallate in Preventing Dermatitis in Patients With Breast Cancer Receiving Postoperative Radiotherapy: A Double-Blind, Placebo-Controlled, Phase 2 Randomized Clinical Trial. JAMA Dermatol. 2022 Jul 1;158(7):779-786. doi: 10.1001/jamadermatol.2022.1736.
Reference Type
BACKGROUND
Xie J, Jia L, Xie P, Yin X, Zhu W, Zhao H, Wang X, Meng X, Xing L, Zhao H, Li X. Efficacy and safety of epigallocatechin-3-gallate in treatment acute severe dermatitis in patients with cancer receiving radiotherapy: a phase I clinical trial. Sci Rep. 2023 Aug 24;13(1):13865. doi: 10.1038/s41598-023-40881-4.
Reference Type
BACKGROUND
Arts IC, Hollman PC, Kromhout D. Chocolate as a source of tea flavonoids. Lancet. 1999 Aug 7;354(9177):488. doi: 10.1016/S0140-6736(99)02267-9.
Reference Type
BACKGROUND
Xicota L, Rodriguez-Morato J, Dierssen M, de la Torre R. Potential Role of (-)-Epigallocatechin-3-Gallate (EGCG) in the Secondary Prevention of Alzheimer Disease. Curr Drug Targets. 2017;18(2):174-195. doi: 10.2174/1389450116666150825113655.
Reference Type
BACKGROUND
Fernando WMADB, Somaratne G, Goozee KG, Williams S, Singh H, Martins RN. Diabetes and Alzheimer's Disease: Can Tea Phytochemicals Play a Role in Prevention? J Alzheimers Dis. 2017;59(2):481-501. doi: 10.3233/JAD-161200.
Reference Type
BACKGROUND
Mandel S, Maor G, Youdim MB. Iron and alpha-synuclein in the substantia nigra of MPTP-treated mice: effect of neuroprotective drugs R-apomorphine and green tea polyphenol (-)-epigallocatechin-3-gallate. J Mol Neurosci. 2004;24(3):401-16. doi: 10.1385/JMN:24:3:401.
Reference Type
BACKGROUND
Jiang S, Huang C, Zheng G, Yi W, Wu B, Tang J, Liu X, Huang B, Wu D, Yan T, Li M, Wan C, Cai Y. EGCG Inhibits Proliferation and Induces Apoptosis Through Downregulation of SIRT1 in Nasopharyngeal Carcinoma Cells. Front Nutr. 2022 Apr 25;9:851972. doi: 10.3389/fnut.2022.851972. eCollection 2022.
Reference Type
BACKGROUND
Cai S, Xie LW, Xu JY, Zhou H, Yang C, Tang LF, Tian Y, Li M. (-)-Epigallocatechin-3-Gallate (EGCG) Modulates the Composition of the Gut Microbiota to Protect Against Radiation-Induced Intestinal Injury in Mice. Front Oncol. 2022 Apr 11;12:848107. doi: 10.3389/fonc.2022.848107. eCollection 2022.
Reference Type
BACKGROUND
Kim SR, Seong KJ, Kim WJ, Jung JY. Epigallocatechin Gallate Protects against Hypoxia-Induced Inflammation in Microglia via NF-kappaB Suppression and Nrf-2/HO-1 Activation. Int J Mol Sci. 2022 Apr 4;23(7):4004. doi: 10.3390/ijms23074004.
Reference Type
BACKGROUND
Spencer JP, Schroeter H, Kuhnle G, Srai SK, Tyrrell RM, Hahn U, Rice-Evans C. Epicatechin and its in vivo metabolite, 3'-O-methyl epicatechin, protect human fibroblasts from oxidative-stress-induced cell death involving caspase-3 activation. Biochem J. 2001 Mar 15;354(Pt 3):493-500. doi: 10.1042/0264-6021:3540493.
Reference Type
BACKGROUND
Suzuki J, Ogawa M, Futamatsu H, Kosuge H, Sagesaka YM, Isobe M. Tea catechins improve left ventricular dysfunction, suppress myocardial inflammation and fibrosis, and alter cytokine expression in rat autoimmune myocarditis. Eur J Heart Fail. 2007 Feb;9(2):152-9. doi: 10.1016/j.ejheart.2006.05.007. Epub 2006 Jul 10.
Reference Type
BACKGROUND
Bhardwaj P, Khanna D. Green tea catechins: defensive role in cardiovascular disorders. Chin J Nat Med. 2013 Jul;11(4):345-53. doi: 10.1016/S1875-5364(13)60051-5.
Reference Type
BACKGROUND
Schiffrin EL. A critical review of the role of endothelial factors in the pathogenesis of hypertension. J Cardiovasc Pharmacol. 2001 Nov;38 Suppl 2:S3-6. doi: 10.1097/00005344-200111002-00002.
Reference Type
BACKGROUND
Galley HF, Webster NR. Physiology of the endothelium. Br J Anaesth. 2004 Jul;93(1):105-13. doi: 10.1093/bja/aeh163. Epub 2004 Apr 30.
Reference Type
BACKGROUND
Hu B, Pan C, Sun Y, Hou Z, Ye H, Zeng X. Optimization of fabrication parameters to produce chitosan-tripolyphosphate nanoparticles for delivery of tea catechins. J Agric Food Chem. 2008 Aug 27;56(16):7451-8. doi: 10.1021/jf801111c. Epub 2008 Jul 16.
Reference Type
BACKGROUND
Rashidinejad A, Birch EJ, Everett DW. A novel functional full-fat hard cheese containing liposomal nanoencapsulated green tea catechins: manufacture and recovery following simulated digestion. Food Funct. 2016 Jul 13;7(7):3283-94. doi: 10.1039/c6fo00354k.
Reference Type
BACKGROUND
Rashidinejad A, Birch EJ, Sun-Waterhouse D, Everett DW. Delivery of green tea catechin and epigallocatechin gallate in liposomes incorporated into low-fat hard cheese. Food Chem. 2014 Aug 1;156:176-83. doi: 10.1016/j.foodchem.2014.01.115. Epub 2014 Feb 6.
Reference Type
BACKGROUND
Rashidinejad A, Boostani S, Babazadeh A, Rehman A, Rezaei A, Akbari-Alavijeh S, Shaddel R, Jafari SM. Opportunities and challenges for the nanodelivery of green tea catechins in functional foods. Food Res Int. 2021 Apr;142:110186. doi: 10.1016/j.foodres.2021.110186. Epub 2021 Feb 1.
Reference Type
BACKGROUND
Wang R, Zhou W, Wen RA. Kinetic study of the thermal stability of tea catechins in aqueous systems using a microwave reactor. J Agric Food Chem. 2006 Aug 9;54(16):5924-32. doi: 10.1021/jf0611419.
Reference Type
BACKGROUND
Zeng J, Xu H, Cai Y, Xuan Y, Liu J, Gao Y, Luan Q. The Effect of Ultrasound, Oxygen and Sunlight on the Stability of (-)-Epigallocatechin Gallate. Molecules. 2018 Sep 18;23(9):2394. doi: 10.3390/molecules23092394.
Reference Type
BACKGROUND
Feng WY. Metabolism of green tea catechins: an overview. Curr Drug Metab. 2006 Oct;7(7):755-809. doi: 10.2174/138920006778520552.
Reference Type
BACKGROUND
Barnett CF, Moreno-Ulloa A, Shiva S, Ramirez-Sanchez I, Taub PR, Su Y, Ceballos G, Dugar S, Schreiner G, Villarreal F. Pharmacokinetic, partial pharmacodynamic and initial safety analysis of (-)-epicatechin in healthy volunteers. Food Funct. 2015 Mar;6(3):824-33. doi: 10.1039/c4fo00596a.
Reference Type
BACKGROUND
Youn HS, Lee JY, Saitoh SI, Miyake K, Kang KW, Choi YJ, Hwang DH. Suppression of MyD88- and TRIF-dependent signaling pathways of Toll-like receptor by (-)-epigallocatechin-3-gallate, a polyphenol component of green tea. Biochem Pharmacol. 2006 Sep 28;72(7):850-9. doi: 10.1016/j.bcp.2006.06.021. Epub 2006 Aug 4.
Reference Type
BACKGROUND
Bors W, Heller W, Michel C, Saran M. Flavonoids as antioxidants: determination of radical-scavenging efficiencies. Methods Enzymol. 1990;186:343-55. doi: 10.1016/0076-6879(90)86128-i. No abstract available.
Reference Type
BACKGROUND
Fan FY, Sang LX, Jiang M. Catechins and Their Therapeutic Benefits to Inflammatory Bowel Disease. Molecules. 2017 Mar 19;22(3):484. doi: 10.3390/molecules22030484.
Reference Type
BACKGROUND
Fraga CG, Galleano M, Verstraeten SV, Oteiza PI. Basic biochemical mechanisms behind the health benefits of polyphenols. Mol Aspects Med. 2010 Dec;31(6):435-45. doi: 10.1016/j.mam.2010.09.006. Epub 2010 Sep 18.
Reference Type
BACKGROUND
Babu PV, Liu D. Green tea catechins and cardiovascular health: an update. Curr Med Chem. 2008;15(18):1840-50. doi: 10.2174/092986708785132979.
Reference Type
BACKGROUND
Cabrera C, Artacho R, Gimenez R. Beneficial effects of green tea--a review. J Am Coll Nutr. 2006 Apr;25(2):79-99. doi: 10.1080/07315724.2006.10719518.
Reference Type
BACKGROUND
Braicu C, Ladomery MR, Chedea VS, Irimie A, Berindan-Neagoe I. The relationship between the structure and biological actions of green tea catechins. Food Chem. 2013 Dec 1;141(3):3282-9. doi: 10.1016/j.foodchem.2013.05.122. Epub 2013 Jun 4.
Reference Type
BACKGROUND
Bernatoniene J, Kopustinskiene DM. The Role of Catechins in Cellular Responses to Oxidative Stress. Molecules. 2018 Apr 20;23(4):965. doi: 10.3390/molecules23040965.
Reference Type
BACKGROUND
Elbaz HA, Lee I, Antwih DA, Liu J, Huttemann M, Zielske SP. Epicatechin stimulates mitochondrial activity and selectively sensitizes cancer cells to radiation. PLoS One. 2014 Feb 6;9(2):e88322. doi: 10.1371/journal.pone.0088322. eCollection 2014.
Reference Type
BACKGROUND
Parshad R, Sanford KK, Price FM, Steele VE, Tarone RE, Kelloff GJ, Boone CW. Protective action of plant polyphenols on radiation-induced chromatid breaks in cultured human cells. Anticancer Res. 1998 Sep-Oct;18(5A):3263-6.
Reference Type
BACKGROUND
Branda RF, Blickensderfer DB. Folate deficiency increases genetic damage caused by alkylating agents and gamma-irradiation in Chinese hamster ovary cells. Cancer Res. 1993 Nov 15;53(22):5401-8.
Reference Type
BACKGROUND
Umegaki K, Uramoto H, Suzuki J, Esashi T. Feeding mice palm carotene prevents DNA damage in bone marrow and reduction of peripheral leukocyte counts, and enhances survival following X-ray irradiation. Carcinogenesis. 1997 Oct;18(10):1943-7. doi: 10.1093/carcin/18.10.1943.
Reference Type
BACKGROUND
Harapanhalli RS, Yaghmai V, Giuliani D, Howell RW, Rao DV. Antioxidant effects of vitamin C in mice following X-irradiation. Res Commun Mol Pathol Pharmacol. 1996 Dec;94(3):271-87.
Reference Type
BACKGROUND
Yoshimura M, Kashiba M, Oka J, Sugisawa A, Umegaki K. Vitamin E prevents increase in oxidative damage to lipids and DNA in liver of ODS rats given total body X-ray irradiation. Free Radic Res. 2002 Jan;36(1):107-12. doi: 10.1080/10715760210166.
Reference Type
BACKGROUND
MacBride SK, Wells ME, Hornsby C, Sharp L, Finnila K, Downie L. A case study to evaluate a new soft silicone dressing, Mepilex Lite, for patients with radiation skin reactions. Cancer Nurs. 2008 Jan-Feb;31(1):E8-14. doi: 10.1097/01.NCC.0000305680.06143.39.
Reference Type
BACKGROUND
Shin YS, Shin HA, Kang SU, Kim JH, Oh YT, Park KH, Kim CH. Effect of epicatechin against radiation-induced oral mucositis: in vitro and in vivo study. PLoS One. 2013 Jul 18;8(7):e69151. doi: 10.1371/journal.pone.0069151. Print 2013.
Reference Type
BACKGROUND
Hoeller U, Tribius S, Kuhlmey A, Grader K, Fehlauer F, Alberti W. Increasing the rate of late toxicity by changing the score? A comparison of RTOG/EORTC and LENT/SOMA scores. Int J Radiat Oncol Biol Phys. 2003 Mar 15;55(4):1013-8. doi: 10.1016/s0360-3016(02)04202-5.
Reference Type
BACKGROUND
Gupta T, Agarwal J, Jain S, Phurailatpam R, Kannan S, Ghosh-Laskar S, Murthy V, Budrukkar A, Dinshaw K, Prabhash K, Chaturvedi P, D'Cruz A. Three-dimensional conformal radiotherapy (3D-CRT) versus intensity modulated radiation therapy (IMRT) in squamous cell carcinoma of the head and neck: a randomized controlled trial. Radiother Oncol. 2012 Sep;104(3):343-8. doi: 10.1016/j.radonc.2012.07.001. Epub 2012 Jul 30.
Reference Type
BACKGROUND
Xiong H, Liao Z, Liu Z, Xu T, Wang Q, Liu H, Komaki R, Gomez D, Wang LE, Wei Q. ATM polymorphisms predict severe radiation pneumonitis in patients with non-small cell lung cancer treated with definitive radiation therapy. Int J Radiat Oncol Biol Phys. 2013 Mar 15;85(4):1066-73. doi: 10.1016/j.ijrobp.2012.09.024. Epub 2012 Nov 12.
Reference Type
BACKGROUND
Cheuk IW, Yip SP, Kwong DL, Wu VW. Association of XRCC1 and XRCC3 gene haplotypes with the development of radiation-induced fibrosis in patients with nasopharyngeal carcinoma. Mol Clin Oncol. 2014 Jul;2(4):553-558. doi: 10.3892/mco.2014.276. Epub 2014 Apr 14.
Reference Type
BACKGROUND
Bray FN, Simmons BJ, Wolfson AH, Nouri K. Acute and Chronic Cutaneous Reactions to Ionizing Radiation Therapy. Dermatol Ther (Heidelb). 2016 Jun;6(2):185-206. doi: 10.1007/s13555-016-0120-y. Epub 2016 Jun 1.
Reference Type
BACKGROUND
Suarez EM, Knackstedt RJ, Jenrette JM. Significant fibrosis after radiation therapy in a patient with Marfan syndrome. Radiat Oncol J. 2014 Sep;32(3):208-12. doi: 10.3857/roj.2014.32.3.208. Epub 2014 Sep 30.
Reference Type
BACKGROUND
Nevens D, Duprez F, Daisne JF, Laenen A, De Neve W, Nuyts S. Radiotherapy induced dermatitis is a strong predictor for late fibrosis in head and neck cancer. The development of a predictive model for late fibrosis. Radiother Oncol. 2017 Feb;122(2):212-216. doi: 10.1016/j.radonc.2016.08.013. Epub 2016 Sep 20.
Reference Type
BACKGROUND
Hamada K, Fujibuchi T, Arakawa H, Yokoyama Y, Yoshida N, Ohura H, Kunitake N, Masuda M, Honda T, Tokuda S, Sasaki M. A novel approach to predict acute radiation dermatitis in patients with head and neck cancer using a model based on Bayesian probability. Phys Med. 2023 Dec;116:103181. doi: 10.1016/j.ejmp.2023.103181. Epub 2023 Nov 24.
Reference Type
BACKGROUND
Lee TF, Liu YH, Chang CH, Chiu CL, Lin CH, Shao JC, Yen YC, Lin GZ, Yang J, Tseng CD, Fang FM, Chao PJ, Lee SH. Development of a risk prediction model for radiation dermatitis following proton radiotherapy in head and neck cancer using ensemble machine learning. Radiat Oncol. 2024 Jun 24;19(1):78. doi: 10.1186/s13014-024-02470-1.
Reference Type
BACKGROUND
Bontempo PSM, Meneses AG, Ciol MA, Ferreira EB, Reis PEDD. Instruments and scales for the evaluation of acute radiation dermatitis: A systematic review. Crit Rev Oncol Hematol. 2023 Nov;191:104116. doi: 10.1016/j.critrevonc.2023.104116. Epub 2023 Aug 28.
Reference Type
BACKGROUND
Noble-Adams R. Radiation-induced skin reactions. 2: Development of a measurement tool. Br J Nurs. 1999 Oct 14-27;8(18):1208-11. doi: 10.12968/bjon.1999.8.18.6490.
Reference Type
BACKGROUND
Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6. doi: 10.1016/0360-3016(95)00060-C. No abstract available.
Reference Type
BACKGROUND
Huang CJ, Hou MF, Luo KH, Wei SY, Huang MY, Su SJ, Kuo HY, Yuan SS, Chen GS, Hu SC, Chuang HY. RTOG, CTCAE and WHO criteria for acute radiation dermatitis correlate with cutaneous blood flow measurements. Breast. 2015 Jun;24(3):230-6. doi: 10.1016/j.breast.2015.01.008. Epub 2015 Mar 14.
Reference Type
BACKGROUND
Berthelet E, Truong PT, Musso K, Grant V, Kwan W, Moravan V, Patterson K, Olivotto IA. Preliminary reliability and validity testing of a new Skin Toxicity Assessment Tool (STAT) in breast cancer patients undergoing radiotherapy. Am J Clin Oncol. 2004 Dec;27(6):626-31. doi: 10.1097/01.coc.0000138965.97476.0f.
Reference Type
BACKGROUND
Aguiar BRL, Ferreira EB, Normando AGC, Mazzeu JF, Assad DX, Guerra ENS, Reis PEDD. Single nucleotide polymorphisms to predict acute radiation dermatitis in breast cancer patients: A systematic review and meta-analysis. Crit Rev Oncol Hematol. 2022 May;173:103651. doi: 10.1016/j.critrevonc.2022.103651. Epub 2022 Mar 15.
Reference Type
BACKGROUND
Yu J, Huang Y, Liu L, Wang J, Yin J, Huang L, Chen S, Li J, Yuan H, Yang G, Liu W, Wang H, Pei Q, Guo C. Genetic polymorphisms of Wnt/beta-catenin pathway genes are associated with the efficacy and toxicities of radiotherapy in patients with nasopharyngeal carcinoma. Oncotarget. 2016 Dec 13;7(50):82528-82537. doi: 10.18632/oncotarget.12754.
Reference Type
BACKGROUND
Mumbrekar KD, Bola Sadashiva SR, Kabekkodu SP, Fernandes DJ, Vadhiraja BM, Suga T, Shoji Y, Nakayama F, Imai T, Satyamoorthy K. Genetic Variants in CD44 and MAT1A Confer Susceptibility to Acute Skin Reaction in Breast Cancer Patients Undergoing Radiation Therapy. Int J Radiat Oncol Biol Phys. 2017 Jan 1;97(1):118-127. doi: 10.1016/j.ijrobp.2016.09.017. Epub 2016 Sep 20.
Reference Type
BACKGROUND
Isomura M, Oya N, Tachiiri S, Kaneyasu Y, Nishimura Y, Akimoto T, Hareyama M, Sugita T, Mitsuhashi N, Yamashita T, Aoki M, Sai H, Hirokawa Y, Sakata K, Karasawa K, Tomida A, Tsuruo T, Miki Y, Noda T, Hiraoka M. IL12RB2 and ABCA1 genes are associated with susceptibility to radiation dermatitis. Clin Cancer Res. 2008 Oct 15;14(20):6683-9. doi: 10.1158/1078-0432.CCR-07-4389.
Reference Type
BACKGROUND
Aguiar BRL, Ferreira EB, Normando AGC, Dias SDS, Guerra ENS, Reis PED. Potential Single Nucleotide Polymorphisms markers for radiation dermatitis in head and neck cancer patients: a meta-analysis. Strahlenther Onkol. 2024 Jul;200(7):568-582. doi: 10.1007/s00066-024-02237-3. Epub 2024 Apr 26.
Reference Type
BACKGROUND
De Langhe S, Mulliez T, Veldeman L, Remouchamps V, van Greveling A, Gilsoul M, De Schepper E, De Ruyck K, De Neve W, Thierens H. Factors modifying the risk for developing acute skin toxicity after whole-breast intensity modulated radiotherapy. BMC Cancer. 2014 Sep 25;14:711. doi: 10.1186/1471-2407-14-711.
Reference Type
BACKGROUND
Ramia P, Bodgi L, Mahmoud D, Mohammad MA, Youssef B, Kopek N, Al-Shamsi H, Dagher M, Abu-Gheida I. Radiation-Induced Fibrosis in Patients with Head and Neck Cancer: A Review of Pathogenesis and Clinical Outcomes. Clin Med Insights Oncol. 2022 Jan 30;16:11795549211036898. doi: 10.1177/11795549211036898. eCollection 2022.
Reference Type
BACKGROUND
Gosselin T, Ginex PK, Backler C, Bruce SD, Hutton A, Marquez CM, McGee LA, Shaftic AM, Suarez LV, Moriarty KA, Maloney C, Vrabel M, Morgan RL. ONS Guidelines for Cancer Treatment-Related Radiodermatitis. Oncol Nurs Forum. 2020 Nov 1;47(6):654-670. doi: 10.1188/20.ONF.654-670.
Reference Type
BACKGROUND
Dorr W. Skin and other reactions to radiotherapy--clinical presentation and radiobiology of skin reactions. Front Radiat Ther Oncol. 2006;39:96-101. doi: 10.1159/000090854. No abstract available.
Reference Type
BACKGROUND
Kyei KA, Daniels J, Pratt-Ainooson F, Anim-Sampong S, Nkansah EO, Amoabeng KA, Antwi WK. Incidence and severity of acute radiation induced toxicities among breast cancer patients treated with adjuvant radiotherapy at a major cancer treatment center in Ghana. Transl Oncol. 2024 Sep;47:102032. doi: 10.1016/j.tranon.2024.102032. Epub 2024 Jun 29.
Reference Type
BACKGROUND
Eggert MC, Yu NY, Rades D. Radiation Dermatitis and Pneumonitis in Patients Irradiated for Breast Cancer. In Vivo. 2023 Nov-Dec;37(6):2654-2661. doi: 10.21873/invivo.13374.
Reference Type
BACKGROUND
Bontempo PSM, Ciol MA, Meneses AG, Simino GPR, Ferreira EB, Reis PEDD. Acute radiodermatitis in cancer patients: incidence and severity estimates. Rev Esc Enferm USP. 2021 Apr 16;55:e03676. doi: 10.1590/S1980-220X2019021703676. eCollection 2021. English, Portuguese.
Reference Type
BACKGROUND
Fijardo M, Kwan JYY, Bissey PA, Citrin DE, Yip KW, Liu FF. The clinical manifestations and molecular pathogenesis of radiation fibrosis. EBioMedicine. 2024 May;103:105089. doi: 10.1016/j.ebiom.2024.105089. Epub 2024 Apr 5.
Reference Type
BACKGROUND
Xie Y, Hu T, Chen R, Chang H, Wang Q, Cheng J. Predicting acute radiation dermatitis in breast cancer: a prospective cohort study. BMC Cancer. 2023 Jun 12;23(1):537. doi: 10.1186/s12885-023-10821-6.
Reference Type
BACKGROUND
Kawamura M, Yoshimura M, Asada H, Nakamura M, Matsuo Y, Mizowaki T. A scoring system predicting acute radiation dermatitis in patients with head and neck cancer treated with intensity-modulated radiotherapy. Radiat Oncol. 2019 Jan 21;14(1):14. doi: 10.1186/s13014-019-1215-2.
Reference Type
BACKGROUND
Tenorio C, de la Mata D, Leyva JAF, Poitevin-Chacon A, Queijeiro MV, Gutierrez GR, Nogueda JC, Cons LCD, Hernandez YB, Sanchez DR, Cruz AAS, Guardado GN, Tomasena MI, Ortiz S, Del Bosque MAS, Garzon LAC, Puch AES, Retif RP, Arceo PRL, Lopez LHB, Baldi CMT. Mexican radiationdermatitis management consensus. Rep Pract Oncol Radiother. 2022 Oct 31;27(5):914-926. doi: 10.5603/RPOR.a2022.0101. eCollection 2022.
Reference Type
BACKGROUND
Spalek M. Chronic radiation-induced dermatitis: challenges and solutions. Clin Cosmet Investig Dermatol. 2016 Dec 9;9:473-482. doi: 10.2147/CCID.S94320. eCollection 2016.
Reference Type
BACKGROUND
Wei J, Meng L, Hou X, Qu C, Wang B, Xin Y, Jiang X. Radiation-induced skin reactions: mechanism and treatment. Cancer Manag Res. 2018 Dec 21;11:167-177. doi: 10.2147/CMAR.S188655. eCollection 2019.
Reference Type
BACKGROUND
Singh M, Alavi A, Wong R, Akita S. Radiodermatitis: A Review of Our Current Understanding. Am J Clin Dermatol. 2016 Jun;17(3):277-92. doi: 10.1007/s40257-016-0186-4.
Reference Type
BACKGROUND
Behroozian T, Goldshtein D, Ryan Wolf J, van den Hurk C, Finkelstein S, Lam H, Patel P, Kanee L, Lee SF, Chan AW, Wong HCY, Caini S, Mahal S, Kennedy S, Chow E, Bonomo P; Multinational Association of Supportive Care in Cancer (MASCC) Oncodermatology Study Group Radiation Dermatitis Guidelines Working Group. MASCC clinical practice guidelines for the prevention and management of acute radiation dermatitis: part 1) systematic review. EClinicalMedicine. 2023 Mar 27;58:101886. doi: 10.1016/j.eclinm.2023.101886. eCollection 2023 Apr.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CI/HRAEB/024/2025
Identifier Type: OTHER
Identifier Source: secondary_id
CEI-038-2025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Effectiveness of Topical Olive Oil in Prevention and Management of Radiation Induced Oral Mucositis
NCT05322421
COMPLETED
NA
Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis
NCT04671862
RECRUITING
NA
Epstein-Barr Virus Reactivation and the Effect of EGCG on Virus Reactivation in Remission Patients
NCT01744587
COMPLETED
NA
Study of ST266 Versus Saline in Treating Skin Irritation From Radiation
NCT01714973
COMPLETED
PHASE1
A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer
NCT00615420
COMPLETED
PHASE3
CD2 Lozenges in Preventing Acute Oral Mucositis in Patients With Head and Neck Cancer Receiving Radiotherapy and Chemotherapy
NCT01545687
WITHDRAWN
PHASE3
Microbiota and Symptom Distress in Head and Neck Cancer Patients Receiving Radiotherapy
NCT04843644
UNKNOWN
NA
Spirulina Derivative for Radiation Esophagitis
NCT07324018
NOT_YET_RECRUITING
PHASE2
Feasibility and Safety of CareMin650 in Patients at Risk of or Suffering From Oral Mucositis and/or Radiation Dermatitis
NCT03988556
COMPLETED
NA
The Formulation of Compound Phellinus Igniarius Decoction on Radiation Pneumonitis
NCT06861179
COMPLETED
PHASE1
Adjunctive Treatments for the Prevention of Radiotherapy-Induced Mucositis
NCT06117904
COMPLETED
NA
Effectiveness of Photobiomodulation Protocols in Radiation-induced Oral Side Effects in H&N Cancer Patients
NCT05242991
UNKNOWN
NA
Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors
NCT06285591
COMPLETED
PHASE2
Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel.
NCT05284487
UNKNOWN
NA
Spirulina-Derived Product Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors
NCT07040969
RECRUITING
PHASE2
Manuka Honey in Preventing Esophagitis-Related Pain in Patients Receiving Chemotherapy and Radiation Therapy For Lung Cancer
NCT01262560
COMPLETED
PHASE2
Photobiomodulation Home-use Device for Prevention or Treatment of Oral Mucositis in Patients With Head&Neck Malignancies
NCT05176834
UNKNOWN
NA
Efficacy of EGF-loaded Self Healing Gel in Treatment of Oral Mucositis
NCT04995354
UNKNOWN
PHASE2/PHASE3
Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia
NCT00503776
TERMINATED
PHASE2
The Effect of Alpha Lipoic Acid on the Incidence and Severity of Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients
NCT05023863
UNKNOWN
PHASE2/PHASE3
Growth Factor to Prevent Oral Mucositis in Patients With Hematologic Cancer
NCT00004132
COMPLETED
PHASE2
Prevention of Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy
NCT03359187
COMPLETED
NA
Inhibition of Oral Tumorigenesis by Antitumor B
NCT04278989
COMPLETED
EARLY_PHASE1
Photobiomodulation in Oral Lesions Resulting From Anti-neoplastic Prevention
NCT04717765
COMPLETED
NA
The Impact of Pentoxifylline and Vitamin E on Radiotherapy-induced Toxicity in Head & Neck Cancer Patients
NCT02397486
COMPLETED
PHASE2