Evidence map›Paper›PMID 26607642›Full record

ArticleThe British journal of radiology2016

Phase I study of topical epigallocatechin-3-gallate (EGCG) in patients with breast cancer receiving adjuvant radiotherapy.

Hanxi Zhao, Wanqi Zhu, Li Jia, Xiaorong Sun, Guanxuan Chen, Xianguang Zhao, Xiaolin Li, Xiangjiao Meng, Lingling Kong, Ligang Xing and 1 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in The British journal of radiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07149506 (Efficacy of Oral or Topical Catechins vs. Placebo as an Adjuvant for the Prevention and Management of Radiation Dermatitis in Oncology Patients), which is not on this map. Cited by 50 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 2 pooled it
4.9field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07149506 phase3enrolling by invitationnot on this mapstarted 2025, after this paper: background citation

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

TypeinterventionalSponsorCARLOS FRANCISCO SAAVEDRA GARCIARan2025 to 2027Enrolled162ConditionsRadiation Dermatitis Acute, Radiation Dermatitis, Fibrosis, SkinArmsEpicatechin, Epigallocatechin Gallate (EGCG), Microcrystalline Cellulose NF (placebo), Saline (0.9% NaCl)
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 2 syntheses or guidelines pooled it, 99 citations in OpenAlex.

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  13. Evolution of radiation-induced dermatitis treatment.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Hanxi Zhao1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong.
Wanqi Zhu1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong.
Li Jia2 Department of Radiation Oncology, Jinan Fourth People's Hospital, Jinan, Shandong.
Xiaorong Sun3 Department of Radiology, Shandong Cancer Hospital and Institute, Jinan, Shandong.
Guanxuan Chen4 Shandong Key Laboratory of Radiation Oncology, Jinan, Shandong, China.
Xianguang Zhao1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong.
Xiaolin Li1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong.
Xiangjiao Meng1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong.
Lingling Kong1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong.
Ligang Xing1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong.
Jinming Yu1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong.
Shandong Tumor Hospital · CNShandong First Medical University · CNFourth People’s Hospital of Jinan · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe purpose of this study was to investigate the safety, tolerability and preliminary effectiveness of topical epigallocatechin-3-gallate (EGCG) for radiation dermatitis in patients with breast cancer receiving adjuvant radiotherapy.

methodsPatients with breast cancer who received radiotherapy to the chest wall after mastectomy were enrolled. EGCG solution was sprayed to the radiation field from the initiation of Grade 1 radiation dermatitis until 2 weeks after completion of radiotherapy. EGCG concentration escalated from 40 to 660 μmol l(-1) in 7 levels with 3-6 patients in each level. EGCG toxicity was graded using the NCI (National Cancer Institute Common Terminology Criteria for Adverse Events) v. 3.0. Any adverse event >Grade 1 attributed to EGCG was considered dose-limiting toxicity. The maximum tolerated dose was defined as the dose level that induced dose-limiting toxicity in more than one-third of patients at a given cohort. Radiation dermatitis was recorded weekly by the Radiation Therapy Oncology Group scoring and patient-reported symptoms.

resultsFrom March 2012 to August 2013, 24 patients were enrolled. Acute skin redness was observed in 1 patient and considered to be associated with the EGCG treatment at 140 μmol l(-1) level. Three more patients were enrolled at this level and did not experience toxicity to EGCG. The dose escalation stopped at 660 μmol l(-1). No other reported acute toxicity was associated with EGCG. Grade 2 radiation dermatitis was observed in eight patients during or after radiotherapy, but all decreased to Grade 1 after EGCG treatments. Patient-reported symptom scores were significantly decreased at 2 weeks after the end of radiotherapy in pain, burning, itching and tenderness, p < 0.05.

conclusionThe topical administration of EGCG was well tolerated and the maximum tolerated dose was not found. EGCG may be effective in treating radiation dermatitis with preliminary investigation. ADVANCES IN KNOWLEDGE: EGCG solution seemed to be feasible for treating radiation dermatitis in patients with breast cancer after mastectomy. It should be tested as a way to reduce radiation-induced normal tissue toxicity and complications in future years.

Indexed as

Administration, TopicalAdultAntioxidantsBreast NeoplasmsCatechinCombined Modality TherapyFemaleHumansMastectomyMiddle AgedRadiodermatitisRadiotherapy, AdjuvantTreatment OutcomeAntioxidantsCatechinepigallocatechin gallate

Identifiers

PMID26607642
PMCPMC4985212
OpenAlexW2178725095

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.