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

• 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: The Canadian College of Naturopathic Medicine
• Collaborators: The Ottawa Hospital; Lotte & John Hecht Memorial Foundation; Gateway for Cancer Research
• Information provided by (Responsible Party): The Canadian College of Naturopathic Medicine

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

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

  Study Documents (Full-Text)

Documents provided by The Canadian College of Naturopathic Medicine:

Study Protocol and Statistical Analysis Plan  [PDF] December 8, 2014

More Information

Additional Information:

The Canadian College of Naturopathic Medicine 

Publications:

Mills E, Wu P, Seely D, Guyatt G. Melatonin in the treatment of cancer: a systematic review of randomized controlled trials and meta-analysis. J Pineal Res. 2005 Nov;39(4):360-6. doi: 10.1111/j.1600-079X.2005.00258.x.

Seely D, Wu P, Fritz H, Kennedy DA, Tsui T, Seely AJ, Mills E. Melatonin as adjuvant cancer care with and without chemotherapy: a systematic review and meta-analysis of randomized trials. Integr Cancer Ther. 2012 Dec;11(4):293-303. doi: 10.1177/1534735411425484. Epub 2011 Oct 21.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Seely D, Legacy M, Auer RC, Fazekas A, Delic E, Anstee C, Angka L, Kennedy MA, Tai LH, Zhang T, Maziak DE, Shamji FM, Sundaresan RS, Gilbert S, Villeneuve PJ, Ashrafi AS, Inculet R, Yasufuku K, Waddell TK, Finley C, Shargall Y, Plourde M, Fergusson DA, Ramsay T, Seely AJE. Adjuvant melatonin for the prevention of recurrence and mortality following lung cancer resection (AMPLCaRe): A randomized placebo controlled clinical trial. EClinicalMedicine. 2021 Feb 27;33:100763. doi: 10.1016/j.eclinm.2021.100763. eCollection 2021 Mar.

• Responsible Party: The Canadian College of Naturopathic Medicine
• ClinicalTrials.gov Identifier: NCT00668707
• Other Study ID Numbers: 2007077-01H
• First Posted: April 29, 2008
• 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:

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