Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality

NCT00668707 | Completed Phase 3 Results DMC

• 1 other identifier: 2007077-01H
• Study Type: interventional
• Target: 709
• Locations: 1 country
• Sites: 8

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.

Conditions

Non Small Cell Lung Cancer

Keywords

melatonin; natural health product (NHP); lung cancer; complementary and alternative medicine (CAM); randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Quality of Life

  2 years

• Fatigue

  2 years

• Sleep

  2 years

• Pain Levels

  3 months

• Anxiety

  2 years

Study Arms (2)

Melatonin

EXPERIMENTAL

To receive 20 mg of melatonin nightly for 1 year post-surgery

Dietary Supplement: melatonin

Placebo

PLACEBO COMPARATOR

To receive 20 mg placebo nightly for 1 year post-surgery

Dietary Supplement: placebo

Interventions

melatonin DIETARY_SUPPLEMENT

20 mgs ingested nightly

Melatonin

placebo DIETARY_SUPPLEMENT

similar to experimental in all ways except for lack of active ingredient

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Taking exogenous melatonin

Sponsors & Collaborators

• The Canadian College of Naturopathic Medicine: lead
• The Ottawa Hospital: collaborator
• Lotte & John Hecht Memorial Foundation: collaborator
• Gateway for Cancer Research: collaborator

Study Sites (8)

Kelowna General Hospital

Kelowna, British Columbia, V1Y 4N7, Canada

Location

Fraser Health

Surrey, British Columbia, V3R 7P8, Canada

Location

QEII Health Sciences Centre/Capital Health

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

St. Joseph's/ McMaster University

Hamilton, Ontario, L8N 4A6, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5C1, Canada

Location

Ottawa General Hospital

Ottawa, Ontario, K1Y 1J7, Canada

Location

University Health Network

Toronto, Ontario, M5G 1Z5, Canada

Location

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, G1V 4G5, Canada

Location

Related Publications (3)

• 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.

  PMID: 16207291 BACKGROUND

• 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.

  PMID: 22019490 BACKGROUND

• 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.

  PMID: 33681747 DERIVED

Related Links

• The Canadian College of Naturopathic Medicine

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Mark Legacy, Clinical Trial Coordinator
• Organization: The Centre for Health Innovation

mlegacy@thechi.ca

613-792-1222

Study Officials

• Dugald MR Seely, ND, MSc

  The Canadian College of Naturopathic Medicine

  PRINCIPAL INVESTIGATOR

• Andrew JE Seely, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: April 29, 2008
• Study Start: September 1, 2007
• Primary Completion: March 9, 2017
• Study Completion: November 30, 2017
• Last Updated: August 3, 2021
• Results First Posted: August 3, 2021

Record last verified: 2021-07

Locations

CA (8)