Evidence map›Paper›PMID 32372215›Full record

Trial reportJournal of the Egyptian National Cancer Institute2020

Effect of melatonin supplementation in combination with neoadjuvant chemotherapy to miR-210 and CD44 expression and clinical response improvement in locally advanced oral squamous cell carcinoma: a randomized controlled trial.

Diani Kartini, Akmal Taher, Sonar Soni Panigoro, Rianto Setiabudy, Sri Widia Jusman, Sofia Mubarika Haryana, Murdani Abdullah, Primariadewi Rustamadji, Denni Joko Purwanto, Noorwati Sutandyo and 4 more

Registry-linked trialOpen access · diamondAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of the Egyptian National Cancer Institute, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04137627 (Effect of Melatonin in Combination With Neoadjuvant Chemotherapy to HIF-1⍺, CD44, CD133, and miR-210 Expression and Clinical Response in Locally Advanced Oral Squamous Cell Carcinoma), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 21% 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.

NCT04137627 phase3completednot on this map

Effect of Melatonin in Combination With Neoadjuvant Chemotherapy to HIF-1⍺, CD44, CD133, and miR-210 Expression and Clinical Response in Locally Advanced Oral Squamous Cell Carcinoma (OSCC)

TypeinterventionalSponsorIndonesia UniversityRan2017 to 2018Enrolled50ConditionsOral Squamous Cell Carcinoma, Neoadjuvant ChemotherapyArmsMelatonin 20 MG Oral Capsule, Placebo oral capsule
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Melatonin in cancer treatment.The Cochrane database of systematic reviews · 2025
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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

14 authors at 4 institutions in 1 country.

Diani KartiniOncology Division, Department of Surgery, Dr. Cipto Mangunkusumo National Central General Hospital, Faculty of Medicine Universitas Indonesia, Jakarta, 10430, Indonesia. d.kartini@gmail.com.ORCID http://orcid.org/0000-0001-8686-2987
Akmal TaherDepartment of Urology, Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
Sonar Soni PanigoroOncology Division, Department of Surgery, Dr. Cipto Mangunkusumo National Central General Hospital, Faculty of Medicine Universitas Indonesia, Jakarta, 10430, Indonesia.
Rianto SetiabudyDepartment of Pharmacology and Therapeutics, Dr. Cipto Mangunkusumo National Central General Hospital, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.
Sri Widia JusmanDepartment of Biochemistry and Molecular Genetics, Dr. Cipto Mangunkusumo National Central General Hospital, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.
Sofia Mubarika HaryanaDepartment of Histology and Cell Biology, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.
Murdani AbdullahDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Dr. Cipto Mangunkusumo National Central General Hospital, Jakarta, Indonesia.
Primariadewi RustamadjiDepartment of Pathological Anatomy, Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
Denni Joko PurwantoDepartment of Surgical Oncology, Dharmais Hospital, National Cancer Center, Jakarta, Indonesia.
Noorwati SutandyoDepartment of Hematology and Medical Oncology, Dharmais Hospital, National Cancer Center, Jakarta, Indonesia.
Indrati SuroyoDepartment of Radiology, Dr. Cipto Mangunkusumo National Central General Hospital, Jakarta, Indonesia.
Budi Harapan SiregarOncology Division, Department of Surgery, Persahabatan General Hospital, Jakarta, Indonesia.
Haris MaruliOncology Division, Department of Surgery, Persahabatan General Hospital, Jakarta, Indonesia.
Saleha SungkarDepartment of Parasitology, Dr. Cipto Mangunkusumo National Central General Hospital, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.
University of Indonesia · IDDharmais Cancer Hospital · IDRumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo · IDUniversitas Gadjah Mada · ID

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSquamous cell carcinoma of the oral cavity (OSCC) is the sixth most common malignancy. Surgery is mainstay treatment for oral cancers. Surgery in locally advanced OSCC presents many challenges primarily because the head and neck have critical structures that can be damaged by tumor or treatment. It is thought that neoadjuvant chemotherapy (NC) in locally advanced OSCC is able to shrink tumor size. Chemoresistancy is a problem due to hypoxic microenvironment characterized by increased expression of HIF-1α. It is also regulated by miR-210 as well as increased expression of CD44 and CD133. Melatonin has a powerful antioxidant and oncostatic effects that are expected to improve tumor hypoxia and clinical response. Fifty patients with OSCC were included and randomized. miR-210 and CD44 expression were measured before and after intervention using qRT-PCR absolute quantification, and clinical response was evaluated according to RECIST 1.1 criteria. This study aims to determine the effect of melatonin in improving the clinical response of patients with locally advanced oral squamous cell carcinoma (OSCC) after neoadjuvant chemotherapy to miR-210 and CD44 expression.

resultsMelatonin administration reduced miR-210 levels but not significant (p = 0.767). CD44 expression also decreased in the melatonin group compared with placebo yet was not significant (p = 0.103). There was a decrease in the expression of miR-210 and CD44 followed by a decrease in the percentage of residual tumor but not significant (p = 0.114).

conclusionIn OSCC, the addition of 20-mg melatonin to neoadjuvant chemotherapy (NC) reduced the expression of miR-210 and CD44 and decreased the percentage of tumor residue; however, no statistically significant result was observed.

trial registrationThis study is registered to ClinicalTrials.gov under trial registration number: NCT04137627 with date of registration on October 22, 2019-retrospectively registered, accessible from: https://clinicaltrials.gov/ct2/show/NCT04137627.

Indexed as

AdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsCell HypoxiaCell Line, TumorChemotherapy, AdjuvantChildDouble-Blind MethodDrug Resistance, NeoplasmFemaleGene Expression Regulation, NeoplasticHumansHyaluronan ReceptorsMaleMelatoninMicroRNAsCD44 protein, humanHyaluronan ReceptorsMelatoninMicroRNAsMIRN210 microRNA, humanCD44Clinical ResponseMelatoninOSCCTumor residue percentage

Identifiers

PMID32372215
PMCPMC13317087
OpenAlexW3026874044

What OpenQuestion holds

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LicenceCC BY
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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.