NCT01706627

Brief Summary

Meta-analysis of previous studies have shown that melatonin is a beneficial adjutant for reducing chemotherapy-induced toxicity; however no randomized, double-blind, placebo controlled trials have been conducted. This study evaluates the effect of melatonin in improving quality of life and reducing chemotherapy-induced toxicity in advanced cancer patients. This is a multi-center, randomized, double-blind, placebo controlled trial conducted in patients with histologically proven advanced non small cell lung, breast, head and neck or sarcoma cancer. Mixed-block randomization, stratified by center and treatment scheme is used to divide eligible patients into three groups: melatonin 20 mg, 10 mg or matched placebo. The patients are required to take the studied drugs at night (after 21.00 pm) on the first day of chemotherapy and continue daily for six months. Standard treatment is chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT), adverse event frequency (CTCAE), oxidative stress status, melatonin level, and survival.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
Last Updated

October 15, 2012

Status Verified

October 1, 2012

Enrollment Period

4.3 years

First QC Date

October 11, 2012

Last Update Submit

October 11, 2012

Conditions

Advanced Stage Cancer

Keywords

cancermelatoninadjuvant therapyquality of lifesurvivaladverse eventsoxidative stress

Outcome Measures

Primary Outcomes (1)

  • Quality of Life (FACT)

    Self-reported questionnaires. FACT-L, FACT-B, FACT-H\&N and FACT-G Thai Version 4 has been previously validated. FACT-L, FACT-B, FACT-H\&N and FACT-G are used in lung, breast, head\&neck and sarcoma cancer patients, respectively. Change from baseline will be evaluated at 1,2,3 and 6 months after treatment.

    Change from baseline in total scores at 6 months after treatment

Secondary Outcomes (4)

  • Number of participants with adverse events

    Baseline and 1,2,3 and 6 months after treatment

  • Oxidative stress status

    Chemotherapy cycles 1,2,3,4

  • Melatonin level

    Chemotherapy cycle 1,2,3 and 4

  • Overall survival

    Over 4 years of the study

Study Arms (3)

Matched placebo

PLACEBO COMPARATOR

Matched placebo (identical formulation and delivery, without active ingredient)

Drug: Matched placebo

Drug: 10 mg Melatonin

ACTIVE COMPARATOR

10 mg melatonin gelatin capsule

Drug: 10 mg Melatonin

Drug: 20 mg Melatonin

ACTIVE COMPARATOR

20 mg melatonin gelatin capsule

Drug: 20 mg Melatonin

Interventions

10 mg MelatoninDRUG

Active Comparator: Drug: Melatonin 10 mg

Drug: 10 mg Melatonin
20 mg MelatoninDRUG

Active Comparator: Drug: Melatonin 20 mg

Drug: 20 mg Melatonin
Matched placeboDRUG

Matched placebo (identical formulation and delivery, without active ingredient)

Matched placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically proven advanced NSCLC, breast, head and neck, sarcoma cancer Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
  • platelet count ≥100,000 cells/mm3
  • white blood cell count ≥ 3,000 cell/mm3
  • hemoglobin ≥ 10 g/dL
  • serum creatinine ≤ 1.5 mg/dL
  • bilirubin ≤ 2 mg/dL
  • AST ≤ 2.5 times upper limit of normal(ULN)for subjects without metastases or AST ≤ 2.5 times UNL for those with liver metastases
  • New York Heart Association grade ≤ 2
  • written consent

You may not qualify if:

  • Patients who receive prior chemotherapy or biotherapy, radiotherapy or surgery within 1 month preceding randomization
  • Patients who have more than one type of cancer or brain metastasis were excluded from the trial.
  • Patients with moderate neuropathy (CTCAE grade ≥ 2)
  • Patients with an active infection, or uncontrolled complications (i.e. blood glucose \> 200 mg/dL, uncontrolled hypertension, unstable angina, history of congestive heart failure or history of myocardial infarction within one year).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Khon Kaen Hospital

Khon Kaen, Changwat Khon Kaen, 40000, Thailand

Location

Srinagarind Hospital

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 11, 2012

First Posted

October 15, 2012

Study Start

August 1, 2007

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

October 15, 2012

Record last verified: 2012-10

Locations

TH(2)