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Melatonin as Adjuvant Therapy in Breast Cancer Patients (MIQOL-B)

Primary Purpose

Stage II and III Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Melatonin
match placebo
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage II and III Breast Cancer focused on measuring breast cancer, melatonin, adjuvant therapy, quality of life, pain, sleep, survival, adverse events

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • histologically proven stage II or III breast 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)
  • New York Heart Association grade ≤ 2
  • written consent

Exclusion Criteria:

  • received prior chemotherapy or biotherapy, radiotherapy or surgery within 1 month preceding randomization,
  • had more than one type of cancer or brain metastasis
  • moderate neuropathy (CTCAE grade ≥ 2)
  • active infection
  • 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).

Sites / Locations

  • Srinagarind Hospital
  • Maharat Nakorn Ratchasima Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Matched placebo

Melatonin 20mg

Arm Description

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

20 mg melatonin gelatin capsule

Outcomes

Primary Outcome Measures

Quality of Life (FACT-B Version 4)
Self-reported questionnaire. FACT-B Thai Version 4 has been previously validated. Change from baseline will be evaluated at months 2,4,6,12,18,24.

Secondary Outcome Measures

Pain and amount of pain medication used
Self-reported VAS scale (0-10)
Number of participants with adverse events
CTCAE Version 4.3
Sleep quality
Self reported VAS scale (0-10)
Cancer recurrence incidence
Progression-free survival

Full Information

First Posted
March 13, 2012
Last Updated
January 6, 2015
Sponsor
Khon Kaen University
Collaborators
National Research Council of Thailand, Srinagarind Hospital, Khon Kaen University, Maharat Hospital, Nakhon Ratchasima, General Drugs House Co.,LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT01557478
Brief Title
Melatonin as Adjuvant Therapy in Breast Cancer Patients
Acronym
MIQOL-B
Official Title
Melatonin in Improving the Quality of Life of Breast Cancer Patients and Reduction of Postoperative Pain and Chemotherapy Induced Toxicity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
Collaborators
National Research Council of Thailand, Srinagarind Hospital, Khon Kaen University, Maharat Hospital, Nakhon Ratchasima, General Drugs House Co.,LTD.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study evaluate the effect of melatonin in improving quality of life and reducing post operative pain and chemotherapy-induced toxicity in breast cancer patients. This is a multi-center, randomized, double-blind, placebo controlled trial conducted in stage II or III breast cancer patients. Mixed-block randomization, stratified by center and treatment scheme is used to divide eligible patients into two groups: melatonin 20 mg or matched placebo. The patients are required to take the studied drugs at night (after 21.00 pm) on the first night prior to surgery and continue for 24 months. Standard treatment is surgery followed by chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT-B), pain (VAS 0-10), adverse event frequency, sleep quality (VAS 0-10), recurrence rate and progression-free survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage II and III Breast Cancer
Keywords
breast cancer, melatonin, adjuvant therapy, quality of life, pain, sleep, survival, adverse events

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Matched placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo (identical formulation and delivery, without active ingredient)
Arm Title
Melatonin 20mg
Arm Type
Active Comparator
Arm Description
20 mg melatonin gelatin capsule
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
20 mg melatonin gelatin capsule (1) taken orally after 21:00 hours each night throughout the study
Intervention Type
Drug
Intervention Name(s)
match placebo
Intervention Description
placebo gelatin capsule (1) taken orally after 21:00 hours each night throughout the study
Primary Outcome Measure Information:
Title
Quality of Life (FACT-B Version 4)
Description
Self-reported questionnaire. FACT-B Thai Version 4 has been previously validated. Change from baseline will be evaluated at months 2,4,6,12,18,24.
Time Frame
Change from baseline in TOI scores at 6 months
Secondary Outcome Measure Information:
Title
Pain and amount of pain medication used
Description
Self-reported VAS scale (0-10)
Time Frame
Before and up to 72 hours after surgery.
Title
Number of participants with adverse events
Description
CTCAE Version 4.3
Time Frame
Baseline and months 2,3,4,5,6,12,18,24
Title
Sleep quality
Description
Self reported VAS scale (0-10)
Time Frame
Baseline, up to 72 hours after surgery and months 2,3,4,5,6,12,18,24
Title
Cancer recurrence incidence
Time Frame
participant will be followed for the duration of study, an expected average of 2 years
Title
Progression-free survival
Time Frame
participant will be followed for the duration of study, an expected average of 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histologically proven stage II or III breast 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) New York Heart Association grade ≤ 2 written consent Exclusion Criteria: received prior chemotherapy or biotherapy, radiotherapy or surgery within 1 month preceding randomization, had more than one type of cancer or brain metastasis moderate neuropathy (CTCAE grade ≥ 2) active infection 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nutjaree P Johns, PharmD,PhD
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Maharat Nakorn Ratchasima Hospital
City
Nakorn Ratchasima
Country
Thailand

12. IPD Sharing Statement

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Melatonin as Adjuvant Therapy in Breast Cancer Patients

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