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NCT Number: NCT00668707

Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality

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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kelowna General Hospital, Kelowna, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

melatonin

Dietary Supplement

20 mgs ingested nightly

Placebo

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Canadian College of Naturopathic Medicine

Other

Collaborators

  • Gateway for Cancer Research
  • Lotte & John Hecht Memorial Foundation
  • The Ottawa Hospital

Registry information

Official study title

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

Acronym: AMPLCaRe

Important dates

Study start
2007
Primary completion
2017
Study completion
2017
First posted
Apr 29, 2008
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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