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

Khon Kaen University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Stage II and III Breast Cancer

Treatments: Drug: Melatonin; Drug: match placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01557478

MIQOL-B

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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166 participants in 2 patient groups, including a placebo group

Matched placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: match placebo

Melatonin 20mg

Active Comparator group

Description:

20 mg melatonin gelatin capsule

Treatment:

Drug: Melatonin