Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00668707
Previous Study | Return to List | Next Study

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 : Completed
First Posted : April 29, 2008
Results First Posted : August 3, 2021
Last Update Posted : August 3, 2021
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 709 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 : March 9, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Melatonin
To receive 20 mg of melatonin nightly for 1 year post-surgery
Dietary Supplement: melatonin
20 mgs ingested nightly

Placebo Comparator: Placebo
To receive 20 mg placebo nightly for 1 year post-surgery
Dietary Supplement: placebo
similar to experimental in all ways except for lack of active ingredient




Primary Outcome Measures :
  1. Lung Cancer Recurrence or Mortality - 2 Years [ Time Frame: 2 years ]
    Disease-Free survival (DFS) at 2 years post-surgery. DFS is measured by the number of participants in both arms who have experienced a recurrence OR mortality at 2 years.


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 2 years ]
    Participant-reported quality of life using the European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire C-30 (EORTC QLQ C-30) and Lung Cancer 13 (EORTC QLQ LC13) questionnaires. Scores represent a value from 0-100. Symptom and LC13 scale: 0 represents best health, 100 worst health. Global and functional scales: 100 represents best health, 0 represents worst health. Full scoring algorithms available here: https://www.eortc.org/app/uploads/sites/2/2018/02/SCmanual.pdf

  2. Fatigue [ Time Frame: 2 years ]
    Measured using the Multidimensional Fatigue Inventory 20 (MFI-20) questionnaire. Scores are on a scale of 0-100, where 100 is the best health and 0 is the worst health.

  3. Sleep [ Time Frame: 2 years ]
    Measured using the Medical Outcomes Study (MOS) Sleep Survey. Scales used were Sleep Adequacy and Sleep problems Index II. Scores are on a scale of 0-100. Sleep Adequacy: 100 represents best health; 0 represents worst health. Problems index: 0 represents best health; 100 represents worst health.

  4. Pain Levels [ Time Frame: 3 months ]
    Calculated using the Brief Pain Inventory. Each scale ranges from 0-10, where 0 is no pain and 10 is the worst possible pain.

  5. Anxiety [ Time Frame: 2 years ]
    Measured using the Beck Anxiety Inventory. Scored range from 0-63, where 0 is no anxiety and 63 is the worst possible anxiety.

  6. Depression [ Time Frame: 2 years ]
    Measured using the Beck Depression Inventory II. Scores range from 0-63, where 0 is no depression and 63 is the worst possible depression.

  7. Adverse Events (Chemotherapy) [ Time Frame: 2 years ]
    Number of participants who experienced an adverse event related to their adjuvant chemotherapy

  8. Lung Cancer Recurrence or Mortality - 5 Years [ Time Frame: up to 5 years ]
    Measured as disease-free survival (DFS) at 5 years. DFS was measured by the incidence of a recurrence OR mortality up to 5 years post-surgery.

  9. Blood Tests to Examine the Effects of Melatonin on the Immune System (Raw Values) [ Time Frame: 6 months ]
    NK cell cytotoxicity changes from baseline to 6 months

  10. Adverse Events (Radiation) [ Time Frame: 2 years ]
    Number of participants who experienced an adverse event related to their adjuvant radiation therapy

  11. Blood Tests to Examine the Effects of Melatonin on the Immune System (Comparison Between Groups) [ Time Frame: 6 months ]
    Differences in NK cell cytotoxicity between both arms



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.


Layout table for eligibility information
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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Dugald MR Seely, ND, MSc The Canadian College of Naturopathic Medicine
Principal Investigator: Andrew JE Seely, MD The Ottawa Hospital
  Study Documents (Full-Text)

Documents provided by The Canadian College of Naturopathic Medicine:
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT00668707    
Other Study ID Numbers: 2007077-01H
First Posted: April 29, 2008    Key Record Dates
Results First Posted: August 3, 2021
Last Update Posted: August 3, 2021
Last Verified: July 2021
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:
Layout table for MeSH terms
Lung Neoplasms
Recurrence
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants