Stage II and III Breast Cancer Clinical Trial
— MIQOL-BOfficial title:
Melatonin in Improving the Quality of Life of Breast Cancer Patients and Reduction of Postoperative Pain and Chemotherapy Induced Toxicity
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.
| Status | Active, not recruiting |
| Enrollment | 166 |
| Est. completion date | |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 70 Years |
| Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Srinagarind Hospital | Khon Kaen | |
| Thailand | Maharat Nakorn Ratchasima Hospital | Nakorn Ratchasima |
| Lead Sponsor | Collaborator |
|---|---|
| Khon Kaen University | General Drug House Ltd., Bangkok, Maharat Hospital, Nakhon Ratchasima, National Research Council of Thailand, Srinagarind Hospital, Khon Kaen University |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Pain and amount of pain medication used | Self-reported VAS scale (0-10) | Before and up to 72 hours after surgery. | No |
| Secondary | Number of participants with adverse events | CTCAE Version 4.3 | Baseline and months 2,3,4,5,6,12,18,24 | No |
| Secondary | Sleep quality | Self reported VAS scale (0-10) | Baseline, up to 72 hours after surgery and months 2,3,4,5,6,12,18,24 | No |
| Secondary | Cancer recurrence incidence | participant will be followed for the duration of study, an expected average of 2 years | No | |
| Secondary | Progression-free survival | participant will be followed for the duration of study, an expected average of 2 years | No |