Evidence map›Paper›PMID 31701429›Full record

ArticleInvestigational new drugs2020

Epigallocatechin-3-gallate mouthwash protects mucosa from radiation-induced mucositis in head and neck cancer patients: a prospective, non-randomised, phase 1 trial.

Wanqi Zhu, Hui Mei, Li Jia, Hanxi Zhao, Xiaolin Li, Xiangjiao Meng, Xianguang Zhao, Ligang Xing, Jinming Yu

2 registry-linked trialsAbstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Investigational new drugs, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
2.1field-weighted citation impact, top 12% 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.

NCT06875791 phase1 / phase2not yet recruitingnot on this mapstarted 2025, after this paper: background citation

A Safety and Efficacy Trial of TV5M01 for Radiation-Induced Mucositis in Patients Undergoing Treatment for Head and Neck Cancer

TypeinterventionalSponsorFundacion Clinica Valle del LiliRan2025 to 2026Enrolled40ConditionsSquamous Cell Carcinoma of the Head and Neck, Oral MucositisArmsGreen Tea Extract with Morphine, Active Comparator: Triple Mixture Oral Rinse for Radiation-Induced Mucositis
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

25 citing papers in PubMed, 40 citations in OpenAlex.

  1. Radiomitigators: Breakthroughs in Post-Radiation Recovery.Antioxidants (Basel, Switzerland) · 2026
    Review
  2. A Review of the Impact of Green Tea (Current pharmaceutical design · 2026
    Review
  3. Article
  4. Cancer chemoprevention: signaling pathways and strategic approaches.Signal transduction and targeted therapy · 2025
    Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Green Tea Catechins: Nature's Way of Preventing and Treating Cancer.International journal of molecular sciences · 2022
    Review
  17. Recent updates on anticancer mechanisms of polyphenols.Frontiers in cell and developmental biology · 2022
    Review
  18. Review
  19. Article
  20. Review
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

9 authors at 3 institutions in 1 country.

Wanqi ZhuTianjin Medical University, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, 250117, Shandong, China.
Hui MeiShandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, 440 Jiyan Road, Jinan, 250117, Shandong, China.
Li JiaJinan Fourth People's Hospital, Jinan, 250031, Shandong, China.
Hanxi ZhaoShandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, 440 Jiyan Road, Jinan, 250117, Shandong, China. zhx87520052@163.com.
Xiaolin LiShandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, 440 Jiyan Road, Jinan, 250117, Shandong, China.
Xiangjiao MengShandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, 440 Jiyan Road, Jinan, 250117, Shandong, China.
Xianguang ZhaoShandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, 440 Jiyan Road, Jinan, 250117, Shandong, China.
Ligang XingShandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, 440 Jiyan Road, Jinan, 250117, Shandong, China. sdcancerhospital@163.com.
Jinming YuTianjin Medical University, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, 250117, Shandong, China.
Shandong Tumor Hospital · CNFourth People’s Hospital of Jinan · CNShandong First Medical University · CN

Funding

Oncology Clinical Trial Accrual StudyR01CA118232 · NCI · UNIVERSITY OF VIRGINIA · PI SCHROEN, ANNEKE T · 2007 to 2009
$861k
6 · The paper itself

Abstract

Radiation-induced oral mucositis has a dismal outcome with limited treatment options. We conducted a phase I study to evaluate the safety and preliminary efficacy of epigallocatechin-3-gallate (EGCG) mouthwash when given along with radiation in head and neck cancer. Patients with pathologically confirmed head and neck cancer were eligible for this study. EGCG mouthwash was administered at the assigned dosage level (starting at 440 μmol/L, three times a day) in a standard 3 + 3 dose escalation design. Mucosal toxicity, patient satisfaction, and mucositis-related pain (MTP) were assessed weekly. The primary endpoint was safety of EGCG, and the secondary endpoint was to determine the relief of the mucositis symptom. The pre- and post-treatment parameters were compared using the paired t-test. 20 patients were enrolled. The maximum tolerated dose of the EGCG mouthwash was 2200 μmol/L. Burning (n = 1/20) and nausea (n = 3/20) were the most common toxicities. No patients experienced WHO Grade 3 or higher mucositis. MTP scores significantly decreased after EGCG administration over time (p < 0.05). Adding EGCG mouthwash to radiotherapy is feasible without increasing toxicities. The recommended dose for phase II study is determined to be 1760 μmol/L, and EGCG administration reduces radiation-induced oral mucosal injury in patients.

Indexed as

ChemoradiotherapyAdultAgedCatechinHead and Neck NeoplasmsHumansMaximum Tolerated DoseMiddle AgedMouth MucosaMouthwashesMucositisProspective StudiesRadiation InjuriesYoung AdultCatechinepigallocatechin gallateMouthwashesEpigallocatechin-3-gallateHead and neck neoplasmsMucositis, radiation-induced

Identifiers

PMID31701429
OpenAlexW2984779753

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.