Trial · NCT04137627

Melatonin Effect in Combination With Neoadjuvant Chemotherapy to Clinical Response in Locally Advanced Oral Squamous Cell Carcinoma

NCT04137627, Phase 3, Completed, Universitas Indonesia; results first posted 2019-12-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Melatonin Effect in Combination With Neoadjuvant Chemotherapy to Clinical Response in Locally Advanced Oral Squamous Cell Carcinoma. Trials, record NCT04137627. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04137627

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Melatonin Effect in Combination With Neoadjuvant Chemotherapy to Clinical Response in Locally Advanced Oral Squamous Cell Carcinoma
NCT number: NCT04137627
Status: Completed
Phases: Phase 3
Enrollment: 50 participants, actual
Lead sponsor: Universitas Indonesia
Conditions: Oral Squamous Cell Carcinoma, Neoadjuvant Chemotherapy
Interventions: Melatonin 20 MG Oral Capsule, Placebo oral capsule
First posted: 2019-10-24
Last updated: 2019-12-09
Results first posted: 2019-12-09
Limitations and caveats: There is a significant number of participants that are enrolled at the initial period of study but did not complete the whole study protocol due to various reasons, therefore statistical power of this study becomes lowered.

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Clinical Response as Measured by RECIST 1.1. Criteria	1 Year	Clinical Response is measured using RECIST 1.1. criteria. CR (Complete response) is defined as disappearance of all target lesion, and pathological lymph node showing reduction of its shortest axis to less than 10 mm. PR (Partial response) is defined as reduction of total target lesion diameter at least by 30%. PD (Progressive disease) is defined as total target lesion diameter increased in size atleast by 20% or 5 mm OR occurence of one new lesion. SD (Stable disease) is defined as absence of reduction or increasing of target lesion. Patients with PR and CR are considered as positive response. Patients with SD and PD are considered as negative response.
Secondary	Change in Expression of HIF-1⍺ as Measured by qRT-PCR Absolute Quantification	1 Year	Expression of HIF-1⍺ is measured at the initial period of the study (baseline) and after 3 neoadjuvant chemotherapy cycles are completed using qRT-PCR Absolute Quantification. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point.
Secondary	Change in Expression of miR-210 as Measured by qRT-PCR Absolute Quantification	1 Year	Expression of miR-210 is measured at the initial period of the study (baseline) and after 3 neoadjuvant chemotherapy cycles are completed using qRT-PCR Absolute Quantification. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point.
Secondary	Change in Expression of CD44 as Measured by qRT-PCR Absolute Quantification	1 Year	Expression of CD44 is measured at the initial period of the study (baseline) and after 3 neoadjuvant chemotherapy cycles are completed using qRT-PCR Absolute Quantification. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point.
Secondary	Change in Expression of CD133 as Measured by qRT-PCR Absolute Quantification	1 Year	Expression of CD133 is measured at the initial period of the study (baseline) and after 3 neoadjuvant chemotherapy cycles are completed using qRT-PCR Absolute Quantification. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Clinical Response as Measured by RECIST 1.1. Criteria	1 Year	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Expression of HIF-1⍺ as Measured by qRT-PCR Absolute Quantification	1 Year	Picogram/microliter	MEDIAN
SECONDARY	Change in Expression of miR-210 as Measured by qRT-PCR Absolute Quantification	1 Year	Picogram/microliter	MEAN
SECONDARY	Change in Expression of CD44 as Measured by qRT-PCR Absolute Quantification	1 Year	Picogram/microliter	MEDIAN
SECONDARY	Change in Expression of CD133 as Measured by qRT-PCR Absolute Quantification	1 Year	Picogram/microliter	MEDIAN

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Clinical Response as Measured by RECIST 1.1. Criteria	Melatonin	Positive Response	5		Participants
Clinical Response as Measured by RECIST 1.1. Criteria	Placebo	Positive Response	5		Participants
Clinical Response as Measured by RECIST 1.1. Criteria	Melatonin	Negative Response	8		Participants
Clinical Response as Measured by RECIST 1.1. Criteria	Placebo	Negative Response	7		Participants
Change in Expression of HIF-1⍺ as Measured by qRT-PCR Absolute Quantification	Melatonin	Pre-Treatment	0.018	Full Range 0.0030 to 0.142	Picogram/microliter
Change in Expression of HIF-1⍺ as Measured by qRT-PCR Absolute Quantification	Placebo	Pre-Treatment	0.0048	Full Range 0.0005 to 0.254	Picogram/microliter
Change in Expression of HIF-1⍺ as Measured by qRT-PCR Absolute Quantification	Melatonin	Post-Treatment	0.012	Full Range 0.0014 to 0.139	Picogram/microliter
Change in Expression of HIF-1⍺ as Measured by qRT-PCR Absolute Quantification	Placebo	Post-Treatment	0.0087	Full Range 0.0004 to 0.060	Picogram/microliter
Change in Expression of HIF-1⍺ as Measured by qRT-PCR Absolute Quantification	Melatonin	Change (Posttreatment - Pretreatment)	-0.008	Full Range -0.131 to 0.085	Picogram/microliter
Change in Expression of HIF-1⍺ as Measured by qRT-PCR Absolute Quantification	Placebo	Change (Posttreatment - Pretreatment)	0.0027	Full Range -0.238 to 0.053	Picogram/microliter

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Melatonin	25
Overall Study	STARTED	Placebo	25
Overall Study	COMPLETED	Melatonin	13
Overall Study	COMPLETED	Placebo	12
Overall Study	NOT COMPLETED	Melatonin	12
Overall Study	NOT COMPLETED	Placebo	13

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Sleep Pattern Disturbance	Nervous system disorders	Melatonin	2	13
other	Sleep Pattern Disturbance	Nervous system disorders	Placebo	2	12
other	Fatigue	General disorders	Melatonin	2	13
other	Fatigue	General disorders	Placebo	3	12
other	Headache	Nervous system disorders	Melatonin	3	13
other	Headache	Nervous system disorders	Placebo	1	12
other	Decreased Alertness	Nervous system disorders	Melatonin	2	13
other	Decreased Alertness	Nervous system disorders	Placebo	0	12
other	Sleepiness	Nervous system disorders	Melatonin	4	13
other	Sleepiness	Nervous system disorders	Placebo	3	12

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Melatonin	0	13
Total, all-cause mortality	Placebo	0	12
Total, other adverse events	Melatonin	13	13
Total, other adverse events	Placebo	12	12
Total, serious adverse events	Melatonin	0	13
Total, serious adverse events	Placebo	0	12

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32372215	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Melatonin vs Placebo: deaths from any cause	Trial comparisons
Melatonin vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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