Stage II and III Breast Cancer
Conditions
Keywords
breast cancer, melatonin, adjuvant therapy, quality of life, pain, sleep, survival, adverse events
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.
Interventions
DRUGMelatonin
20 mg melatonin gelatin capsule (1) taken orally after 21:00 hours each night throughout the study
DRUGmatch placebo
placebo gelatin capsule (1) taken orally after 21:00 hours each night throughout the study
Sponsors
National Research Council of Thailand
Srinagarind Hospital, Khon Kaen University
Maharat Hospital, Nakhon Ratchasima
General Drugs House Co.,LTD.
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (FACT-B Version 4) | Change from baseline in TOI scores at 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain and amount of pain medication used | Before and up to 72 hours after surgery. | Self-reported VAS scale (0-10) |
| Number of participants with adverse events | Baseline and months 2,3,4,5,6,12,18,24 | CTCAE Version 4.3 |
| Sleep quality | Baseline, up to 72 hours after surgery and months 2,3,4,5,6,12,18,24 | Self reported VAS scale (0-10) |
| 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 | — |
Countries
Thailand
Outcome results
None listed