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Melatonin In Cancer Patients Receiving Chemotherapy: A Randomized, Double Blind, Placebo, Controlled Trial

Phase 2/Phase 3
18 Years
70 Years
Not Enrolling
Advanced Stage Cancer

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Trial Information

Melatonin In Cancer Patients Receiving Chemotherapy: A Randomized, Double Blind, Placebo, Controlled Trial

Inclusion Criteria:

- histologically proven advanced NSCLC, breast, head and neck, sarcoma 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)for subjects without metastases or AST ≤
2.5 times UNL for those with liver metastases

- New York Heart Association grade ≤ 2

- written consent

Exclusion Criteria:

- Patients who receive prior chemotherapy or biotherapy, radiotherapy or surgery within
1 month preceding randomization

- Patients who have more than one type of cancer or brain metastasis were excluded from
the trial.

- Patients with moderate neuropathy (CTCAE grade ≥ 2)

- Patients with an active infection, or 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:


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)

Outcome Description:

Self-reported questionnaires. FACT-L, FACT-B, FACT-H&N and FACT-G Thai Version 4 has been previously validated. FACT-L, FACT-B, FACT-H&N and FACT-G are used in lung, breast, head&neck and sarcoma cancer patients, respectively. Change from baseline will be evaluated at 1,2,3 and 6 months after treatment.

Outcome Time Frame:

Change from baseline in total scores at 6 months after treatment

Safety Issue:



Thailand: Khon Kaen University Ethics Committee for Human Research

Study ID:




Start Date:

August 2007

Completion Date:

June 2012

Related Keywords:

  • Advanced Stage Cancer
  • cancer
  • melatonin
  • adjuvant therapy
  • quality of life
  • survival
  • adverse events
  • oxidative stress