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Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality: A Randomized Placebo Controlled Clinical Trial


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality: A Randomized Placebo Controlled Clinical Trial


The trial employs a two-armed parallel placebo controlled trial design whereby patients with
a diagnosis of non small cell lung cancer are randomized to receive either 20 mg of
melatonin nightly or an identically matched placebo. All patients will be followed for two
years with primary outcomes assessed at a two year time point and secondary outcomes
evaluated throughout the course of the trial.


Inclusion Criteria:



- Clinical diagnosis of non small cell lung cancer

- Eligible for surgical resection

- Willingness to adhere to randomized treatment

- Availability for follow-up schedule of visits

Exclusion Criteria:

- Taking exogenous melatonin

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Lung Cancer Recurrence or mortality

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Dugald MR Seely, ND, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Canadian College of Naturopathic Medicine

Authority:

Canada: Health Canada

Study ID:

2007077-01H

NCT ID:

NCT00668707

Start Date:

September 2007

Completion Date:

March 2017

Related Keywords:

  • Non Small Cell Lung Cancer
  • melatonin
  • natural health product (NHP)
  • lung cancer
  • complementary and alternative medicine (CAM)
  • randomized clinical trial
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Recurrence

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