Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04137627
Recruitment Status : Completed
First Posted : October 24, 2019
Results First Posted : December 9, 2019
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
dr. Diani Kartini,SpB(K)Onk, Indonesia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Oral Squamous Cell Carcinoma
Neoadjuvant Chemotherapy
Interventions Drug: Melatonin 20 MG Oral Capsule
Drug: Placebo oral capsule
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Melatonin Placebo
Hide Arm/Group Description

The group received standard treatment with the oral administration of Melatonin

Melatonin 20 MG Oral Capsule: The administration of Melatonin 20 mg in addition to neoadjuvant chemotherapy to observe the antioxidant and onco-static effect.

The group received standard treatment with the oral administration of Placebo

Placebo oral capsule: The administration of placebo capsule in addition to neoadjuvant chemotherapy

Period Title: Overall Study
Started 25 25
Completed 13 12
Not Completed 12 13
Arm/Group Title Melatonin Group Placebo Group Total
Hide Arm/Group Description Participants who received Melatonin (treatment arm) who finished study protocol Participants who received Placebo (control arm) who finished study protocol Total of all reporting groups
Overall Number of Baseline Participants 13 12 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Less than or equal to 50 years
5
  38.5%
7
  58.3%
12
  48.0%
Greater than 50 years
8
  61.5%
5
  41.7%
13
  52.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Female
5
  38.5%
5
  41.7%
10
  40.0%
Male
8
  61.5%
7
  58.3%
15
  60.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Indonesia Number Analyzed 13 participants 12 participants 25 participants
13
 100.0%
12
 100.0%
25
 100.0%
Tumor Location  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Tongue
10
  76.9%
9
  75.0%
19
  76.0%
Buccal
1
   7.7%
1
   8.3%
2
   8.0%
Palate
0
   0.0%
1
   8.3%
1
   4.0%
Mandible
1
   7.7%
1
   8.3%
2
   8.0%
Gingiva (Gum)
1
   7.7%
0
   0.0%
1
   4.0%
Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Stage IV A
12
  92.3%
10
  83.3%
22
  88.0%
Stage IV B
1
   7.7%
2
  16.7%
3
  12.0%
[1]
Measure Description: Stage of patients is performed referring to 8th edition 2017 American Joint Committee on Cancer (AJCC) Staging based on TNM (Primary tumor, Regional lymph nodes, Distant metastasis). Patients with Stage IVa is in general considered to have a better outcome than those of having Stage IVb.
Keratinized/non-keratinized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Keratinized
12
  92.3%
6
  50.0%
18
  72.0%
Non-keratinized
1
   7.7%
6
  50.0%
7
  28.0%
Differentiation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Well Differentiated
5
  38.5%
4
  33.3%
9
  36.0%
Moderately Differentiated
5
  38.5%
3
  25.0%
8
  32.0%
Poorly Differentiated
3
  23.1%
5
  41.7%
8
  32.0%
Grade  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
High Grade
6
  46.2%
11
  91.7%
17
  68.0%
Low Grade
7
  53.8%
1
   8.3%
8
  32.0%
Medication adherence  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Strict adherence
10
  76.9%
9
  75.0%
19
  76.0%
Poor adherence
3
  23.1%
3
  25.0%
6
  24.0%
1.Primary Outcome
Title Clinical Response as Measured by RECIST 1.1. Criteria
Hide Description 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.
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melatonin Placebo
Hide Arm/Group Description:

The group received standard treatment with the oral administration of Melatonin

Melatonin 20 MG Oral Capsule: The administration of Melatonin 20 mg in addition to neoadjuvant chemotherapy to observe the antioxidant and onco-static effect.

The group received standard treatment with the oral administration of Placebo

Placebo oral capsule: The administration of placebo capsule in addition to neoadjuvant chemotherapy

Overall Number of Participants Analyzed 13 12
Measure Type: Count of Participants
Unit of Measure: Participants
Positive Response
5
  38.5%
5
  41.7%
Negative Response
8
  61.5%
7
  58.3%
2.Secondary Outcome
Title Change in Expression of HIF-1⍺ as Measured by qRT-PCR Absolute Quantification
Hide Description 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.
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melatonin Placebo
Hide Arm/Group Description:

The group received standard treatment with the oral administration of Melatonin

Melatonin 20 MG Oral Capsule: The administration of Melatonin 20 mg in addition to neoadjuvant chemotherapy to observe the antioxidant and onco-static effect.

The group received standard treatment with the oral administration of Placebo

Placebo oral capsule: The administration of placebo capsule in addition to neoadjuvant chemotherapy

Overall Number of Participants Analyzed 13 12
Median (Full Range)
Unit of Measure: Picogram/microliter
Pre-Treatment
0.018
(0.0030 to 0.142)
0.0048
(0.0005 to 0.254)
Post-Treatment
0.012
(0.0014 to 0.139)
0.0087
(0.0004 to 0.060)
Change (Posttreatment - Pretreatment)
-0.008
(-0.131 to 0.085)
0.0027
(-0.238 to 0.053)
3.Secondary Outcome
Title Change in Expression of miR-210 as Measured by qRT-PCR Absolute Quantification
Hide Description 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.
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melatonin Placebo
Hide Arm/Group Description:

The group received standard treatment with the oral administration of Melatonin

Melatonin 20 MG Oral Capsule: The administration of Melatonin 20 mg in addition to neoadjuvant chemotherapy to observe the antioxidant and onco-static effect.

The group received standard treatment with the oral administration of Placebo

Placebo oral capsule: The administration of placebo capsule in addition to neoadjuvant chemotherapy

Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: Picogram/microliter
Pre-Treatment 162.8  (54.92) 175.2  (34.3)
Post-Treatment 53.8  (16.65) 53.5  (14.28)
Change (Posttreatment - Pretreatment) -109.09  (51.62) -103.71  (36.24)
4.Secondary Outcome
Title Change in Expression of CD44 as Measured by qRT-PCR Absolute Quantification
Hide Description 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.
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melatonin Placebo
Hide Arm/Group Description:

The group received standard treatment with the oral administration of Melatonin

Melatonin 20 MG Oral Capsule: The administration of Melatonin 20 mg in addition to neoadjuvant chemotherapy to observe the antioxidant and onco-static effect.

The group received standard treatment with the oral administration of Placebo

Placebo oral capsule: The administration of placebo capsule in addition to neoadjuvant chemotherapy

Overall Number of Participants Analyzed 13 12
Median (Full Range)
Unit of Measure: Picogram/microliter
Pre-Treatment
0.0349
(0.0048 to 0.1440)
0.0095
(0.0002 to 0.1170)
Post-Treatment
0.0115
(0.0003 to 0.2040)
0.0187
(0.0012 to 0.2780)
Change (Posttreatment - Pretreatment)
-0.0114
(-0.0994 to 0.1736)
0.0082
(-0.1109 to 0.2773)
5.Secondary Outcome
Title Change in Expression of CD133 as Measured by qRT-PCR Absolute Quantification
Hide Description 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.
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melatonin Placebo
Hide Arm/Group Description:

The group received standard treatment with the oral administration of Melatonin

Melatonin 20 MG Oral Capsule: The administration of Melatonin 20 mg in addition to neoadjuvant chemotherapy to observe the antioxidant and onco-static effect.

The group received standard treatment with the oral administration of Placebo

Placebo oral capsule: The administration of placebo capsule in addition to neoadjuvant chemotherapy

Overall Number of Participants Analyzed 13 12
Median (Full Range)
Unit of Measure: Picogram/microliter
Pre-Treatment
1.13
(0.14 to 4.73)
1.07
(0.04 to 5.64)
Post-Treatment
1.42
(0.11 to 2.85)
1.88
(0.22 to 20.90)
Change (Posttreatment - Pretreatment)
0.43
(-3.50 to 1.37)
0.55
(-2.33 to 18.20)
Time Frame 56 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Melatonin Placebo
Hide Arm/Group Description

The group received standard treatment with the oral administration of Melatonin

Melatonin 20 MG Oral Capsule: The administration of Melatonin 20 mg in addition to neoadjuvant chemotherapy to observe the antioxidant and onco-static effect.

The group received standard treatment with the oral administration of Placebo

Placebo oral capsule: The administration of placebo capsule in addition to neoadjuvant chemotherapy

All-Cause Mortality
Melatonin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/12 (0.00%) 
Hide Serious Adverse Events
Melatonin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Melatonin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   13/13 (100.00%)   12/12 (100.00%) 
General disorders     
Fatigue   2/13 (15.38%)  3/12 (25.00%) 
Nervous system disorders     
Sleep Pattern Disturbance   2/13 (15.38%)  2/12 (16.67%) 
Headache   3/13 (23.08%)  1/12 (8.33%) 
Decreased Alertness   2/13 (15.38%)  0/12 (0.00%) 
Sleepiness   4/13 (30.77%)  3/12 (25.00%) 
Hallucination   1/13 (7.69%)  0/12 (0.00%) 
Psychiatric disorders     
Emotional Changes   2/13 (15.38%)  3/12 (25.00%) 
Indicates events were collected by systematic assessment
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. dr. Diani Kartini, Sp.B-K(Onk)
Organization: Universitas Indonesia
Phone: +628122684919
EMail: d.kartini@gmail.com
Layout table for additonal information
Responsible Party: dr. Diani Kartini,SpB(K)Onk, Indonesia University
ClinicalTrials.gov Identifier: NCT04137627    
Other Study ID Numbers: MLTOSCC
First Submitted: October 22, 2019
First Posted: October 24, 2019
Results First Submitted: October 29, 2019
Results First Posted: December 9, 2019
Last Update Posted: December 9, 2019