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Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality (AMPLCaRe)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by The Canadian College of Naturopathic Medicine
Sponsor:
Collaborators:
The Ottawa Hospital
Lotte & John Hecht Memorial Foundation
Gateway for Cancer Research
Information provided by (Responsible Party):
The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier:
NCT00668707
First received: April 25, 2008
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

There is evidence to support the use of melatonin, a natural health product, as an additional treatment aid for cancer patients. This study is designed to see if the daily ingestion of 20 milligrams of melatonin for one year can lower the incidence of developing lung cancer recurrence and/or death. Only patients with a diagnosis of non small cell lung cancer who are eligible for surgical resection can participate in the trial. The study will also be assessing for changes in quality of life, pain, fatigue, anxiety, sleep, and depression amongst the participants.


Condition Intervention Phase
Non Small Cell Lung Cancer
Dietary Supplement: melatonin
Dietary Supplement: placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by The Canadian College of Naturopathic Medicine:

Primary Outcome Measures:
  • Lung Cancer Recurrence or mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Fatigue [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Sleep [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Anxiety [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • lung cancer recurrence or mortality [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • blood tests to examine the effects of melatonin on the immune system [ Time Frame: baseline (before starting melatonin) and 6 months post-op ] [ Designated as safety issue: No ]

Estimated Enrollment: 711
Study Start Date: September 2007
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
To receive 20 mg of melatonin nightly for 1 year
Dietary Supplement: melatonin
20 mgs ingested nightly
Placebo Comparator: 2
To receive matched supplement to the experimental arm in same schedule
Dietary Supplement: placebo
similar to experimental in all ways except for lack of active ingredient

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668707

Contacts
Contact: Andrew JE Seely, MD, PhD 613-737-8899 ext 74892 aseely@ottawahospital.on.ca
Contact: Dugald Seely, ND, MSc 613-792-1222 ext 211 dseely@oicc.edu

Locations
Canada, British Columbia
Kelowna General Hospital Active, not recruiting
Kelowna, British Columbia, Canada, V1Y 4N7
Fraser Health Active, not recruiting
Surrey, British Columbia, Canada, V3R 7P8
Canada, Nova Scotia
QEII Health Sciences Centre/Capital Health Active, not recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
St. Joseph's/ McMaster University Active, not recruiting
Hamilton, Ontario, Canada, L8N 4A6
London Health Sciences Centre Active, not recruiting
London, Ontario, Canada, N6A 5C1
Ottawa General Hospital Recruiting
Ottawa, Ontario, Canada, K1Y 1J7
Principal Investigator: Andrew JE Seely, MD         
Sub-Investigator: Donna Maziak, MD         
Sub-Investigator: Farid Shamji, MD         
Sub-Investigator: Sudhir Sundaresan, MD         
Sub-Investigator: Scott Laurie, MD         
Sub-Investigator: Rob McRae, MD         
Sub-Investigator: Sebastien Gilbert, MD         
Sub-Investigator: P James Villeneuve, MD         
University Health Network Active, not recruiting
Toronto, Ontario, Canada, M5G 1Z5
Canada
Institut universitaire de cardiologie et de pneumologie de Québec Active, not recruiting
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
The Canadian College of Naturopathic Medicine
The Ottawa Hospital
Lotte & John Hecht Memorial Foundation
Gateway for Cancer Research
Investigators
Principal Investigator: Dugald MR Seely, ND, MSc The Canadian College of Naturopathic Medicine
Principal Investigator: Andrew JE Seely, MD The Ottawa Hospital
  More Information

Additional Information:
Publications:
Responsible Party: The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT00668707     History of Changes
Other Study ID Numbers: 2007077-01H
Study First Received: April 25, 2008
Last Updated: October 28, 2014
Health Authority: Canada: Health Canada

Keywords provided by The Canadian College of Naturopathic Medicine:
melatonin
natural health product (NHP)
lung cancer
complementary and alternative medicine (CAM)
randomized clinical trial

Additional relevant MeSH terms:
Lung Neoplasms
Bronchial Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Neoplasms
Thoracic Neoplasms
Physiological Effects of Drugs
Carcinoma, Non-Small-Cell Lung
Recurrence
Carcinoma, Bronchogenic
Disease Attributes
Lung Diseases
Pathologic Processes
Respiratory Tract Diseases
Melatonin
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014