Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality

Non Small Cell Lung Cancer Clinical Trial

— AMPLCaRe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668707
• Other study ID #: 2007077-01H
• Status: Completed
• Phase: Phase 3
• Start date: September 2007
• Est. completion date: November 30, 2017

Study information

• Verified date: July 2021
• Source: The Canadian College of Naturopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 709
• Est. completion date: November 30, 2017
• Est. primary completion date: March 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Non Small Cell Lung Cancer
• Recurrence

Intervention

Dietary Supplement:
• melatonin
20 mgs ingested nightly
• placebo
similar to experimental in all ways except for lack of active ingredient

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre/Capital Health	Halifax	Nova Scotia
Canada	St. Joseph's/ McMaster University	Hamilton	Ontario
Canada	Kelowna General Hospital	Kelowna	British Columbia
Canada	London Health Sciences Centre	London	Ontario
Canada	Ottawa General Hospital	Ottawa	Ontario
Canada	Institut universitaire de cardiologie et de pneumologie de Québec	Quebec
Canada	Fraser Health	Surrey	British Columbia
Canada	University Health Network	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
The Canadian College of Naturopathic Medicine	Gateway for Cancer Research, Lotte & John Hecht Memorial Foundation, The Ottawa Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Cancer Recurrence or Mortality - 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.	2 years
Secondary	Quality of Life	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 years
Secondary	Fatigue	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.	2 years
Secondary	Sleep	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.	2 years
Secondary	Pain Levels	Calculated using the Brief Pain Inventory. Each scale ranges from 0-10, where 0 is no pain and 10 is the worst possible pain.	3 months
Secondary	Anxiety	Measured using the Beck Anxiety Inventory. Scored range from 0-63, where 0 is no anxiety and 63 is the worst possible anxiety.	2 years
Secondary	Depression	Measured using the Beck Depression Inventory II. Scores range from 0-63, where 0 is no depression and 63 is the worst possible depression.	2 years
Secondary	Adverse Events (Chemotherapy)	Number of participants who experienced an adverse event related to their adjuvant chemotherapy	2 years
Secondary	Lung Cancer Recurrence or Mortality - 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.	up to 5 years
Secondary	Blood Tests to Examine the Effects of Melatonin on the Immune System (Raw Values)	NK cell cytotoxicity changes from baseline to 6 months	6 months
Secondary	Adverse Events (Radiation)	Number of participants who experienced an adverse event related to their adjuvant radiation therapy	2 years
Secondary	Blood Tests to Examine the Effects of Melatonin on the Immune System (Comparison Between Groups)	Differences in NK cell cytotoxicity between both arms	6 months

External Links

•   The Canadian College of Naturopathic Medicine