Melatonin as Adjuvant Therapy in Breast Cancer Patients

NCT01557478 | Unknown Phase 2

• 1 other identifier: MIQOL-B
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 2

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.

Conditions

Stage II and III Breast Cancer

Keywords

breast cancer; melatonin; adjuvant therapy; quality of life; pain; sleep; survival; adverse events

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline in TOI scores at 6 months

Secondary Outcomes (5)

• Pain and amount of pain medication used

  Before and up to 72 hours after surgery.

• Number of participants with adverse events

  Baseline and months 2,3,4,5,6,12,18,24

• Sleep quality

  Baseline, up to 72 hours after surgery and months 2,3,4,5,6,12,18,24

• Cancer recurrence incidence

  participant will be followed for the duration of study, an expected average of 2 years

• Progression-free survival

  participant will be followed for the duration of study, an expected average of 2 years

Study Arms (2)

Matched placebo

PLACEBO COMPARATOR

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

Drug: match placebo

Melatonin 20mg

ACTIVE COMPARATOR

20 mg melatonin gelatin capsule

Drug: Melatonin

Interventions

Melatonin DRUG

20 mg melatonin gelatin capsule (1) taken orally after 21:00 hours each night throughout the study

Melatonin 20mg

match placebo DRUG

placebo gelatin capsule (1) taken orally after 21:00 hours each night throughout the study

Matched placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Khon Kaen University: lead
• National Research Council of Thailand: collaborator
• Srinagarind Hospital, Khon Kaen University: collaborator
• Maharat Hospital, Nakhon Ratchasima: collaborator
• General Drugs House Co.,LTD.: collaborator

Study Sites (2)

Srinagarind Hospital

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Maharat Nakorn Ratchasima Hospital

Nakorn Ratchasima, Nakorn Ratchasima, Thailand

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Nutjaree P Johns, PharmD,PhD

  Khon Kaen University

  PRINCIPAL INVESTIGATOR

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: March 13, 2012
• First Posted: March 19, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2016
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

TH (2)