Clinical trial NCT01557478: Melatonin as Adjuvant Therapy in Breast Cancer Patients
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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Stage II and III Breast Cancer
Keywords: breast cancer
melatonin
adjuvant therapy
quality of life
pain
sleep
survival
adverse events
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
Collaborators: name: National Research Council of Thailand
name: Srinagarind Hospital, Khon Kaen University
name: Maharat Hospital, Nakhon Ratchasima
name: General Drugs House Co.,LTD.
First posted: 2012-03-19
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Quality of Life (FACT-B Version 4)
timeFrame: Change from baseline in TOI scores at 6 months
Secondary outcomes:
measure: Pain and amount of pain medication used
timeFrame: Before and up to 72 hours after surgery.
measure: Number of participants with adverse events
timeFrame: Baseline and months 2,3,4,5,6,12,18,24
measure: Sleep quality
timeFrame: Baseline, up to 72 hours after surgery and months 2,3,4,5,6,12,18,24
measure: Cancer recurrence incidence
timeFrame: participant will be followed for the duration of study, an expected average of 2 years
measure: Progression-free survival
timeFrame: participant will be followed for the duration of study, an expected average of 2 years
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Nakorn Ratchasima
country: Thailand
facility: Maharat Nakorn Ratchasima Hospital
Study officials:
affiliation: Khon Kaen University
name: Nutjaree P Johns, PharmD,PhD
role: PRINCIPAL_INVESTIGATOR
References: