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Melatonin in Improving the Quality of Life of Breast Cancer Patients and Reduction of Postoperative Pain and Chemotherapy Induced Toxicity


Phase 2/Phase 3
18 Years
70 Years
Open (Enrolling)
Female
Stage II and III Breast Cancer

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Trial Information

Melatonin in Improving the Quality of Life of Breast Cancer Patients and Reduction of Postoperative Pain and Chemotherapy Induced Toxicity


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Quality of Life (FACT-B Version 4)

Outcome Description:

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.

Outcome Time Frame:

Change from baseline in TOI scores at 6 months

Safety Issue:

No

Principal Investigator

Nutjaree P Johns, PharmD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Khon Kaen University

Authority:

Thailand: Khon Kaen University Ethics Committee for Human Research

Study ID:

MIQOL-B

NCT ID:

NCT01557478

Start Date:

March 2012

Completion Date:

Related Keywords:

  • Stage II and III Breast Cancer
  • breast cancer
  • melatonin
  • adjuvant therapy
  • quality of life
  • pain
  • sleep
  • survival
  • adverse events
  • Breast Neoplasms

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