ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00668707
Recruitment Status : Active, not recruiting
First Posted : April 29, 2008
Last Update Posted : June 9, 2017
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

Brief Summary:
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 or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Dietary Supplement: melatonin Dietary Supplement: placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 711 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality: A Randomized Placebo Controlled Clinical Trial
Study Start Date : September 2007
Actual Primary Completion Date : May 2017
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Melatonin

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Lung Cancer Recurrence or mortality [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 2 years ]
  2. Fatigue [ Time Frame: 2 years ]
  3. Sleep [ Time Frame: 2 years ]
  4. Pain [ Time Frame: 3 months ]
  5. Anxiety [ Time Frame: 2 years ]
  6. Depression [ Time Frame: 2 years ]
  7. Adverse events [ Time Frame: 2 years ]
  8. lung cancer recurrence or mortality [ Time Frame: up to 5 years ]
  9. blood tests to examine the effects of melatonin on the immune system [ Time Frame: baseline (before starting melatonin) and 6 months post-op ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668707


Locations
Canada, British Columbia
Kelowna General Hospital
Kelowna, British Columbia, Canada, V1Y 4N7
Fraser Health
Surrey, British Columbia, Canada, V3R 7P8
Canada, Nova Scotia
QEII Health Sciences Centre/Capital Health
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
St. Joseph's/ McMaster University
Hamilton, Ontario, Canada, L8N 4A6
London Health Sciences Centre
London, Ontario, Canada, N6A 5C1
Ottawa General Hospital
Ottawa, Ontario, Canada, K1Y 1J7
University Health Network
Toronto, Ontario, Canada, M5G 1Z5
Canada
Institut universitaire de cardiologie et de pneumologie de Québec
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

Additional Information:
Publications:
Responsible Party: The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT00668707     History of Changes
Other Study ID Numbers: 2007077-01H
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017

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