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Non Small Cell Lung CancerPhase 3AMPLCaReNCT00668707

Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality

A Phase 3 study testing melatonin in people with Non Small Cell Lung Cancer, run by The Canadian College of Naturopathic Medicine at 8 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
melatonin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
709 participants
Where
8 sitesCanada
Study dates
Sep 2007to 30 Nov 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Taking exogenous melatonin

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Canada8 sites

  • QEII Health Sciences Centre/Capital Health

    Halifax, Nova Scotia, B3H 2Y9

  • St. Joseph's/ McMaster University

    Hamilton, Ontario, L8N 4A6

  • Kelowna General Hospital

    Kelowna, British Columbia, V1Y 4N7

  • London Health Sciences Centre

    London, Ontario, N6A 5C1

  • Ottawa General Hospital

    Ottawa, Ontario, K1Y 1J7

  • Institut universitaire de cardiologie et de pneumologie de Québec

    Québec, G1V 4G5

  • Fraser Health

    Surrey, British Columbia, V3R 7P8

  • University Health Network

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
melatonin, placebo
Keywords
melatonin, natural health product (NHP), lung cancer, complementary and alternative medicine (CAM), randomized clinical trial
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • melatoninDietary supplement

    20 mgs ingested nightly

  • placeboDietary supplement

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

Study groups in NCT00668707
Study groupRoleWhat they receive
MelatoninExperimentalTo receive 20 mg of melatonin nightly for 1 year post-surgery
Receives: Dietary Supplement: melatonin
PlaceboPlacebo comparatorTo receive 20 mg placebo nightly for 1 year post-surgery
Receives: Dietary Supplement: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (11)

  1. 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

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. 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.

    Measured: 2 years

  4. 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.

    Measured: 3 months

  5. Anxiety

    Measured using the Beck Anxiety Inventory. Scored range from 0-63, where 0 is no anxiety and 63 is the worst possible anxiety.

    Measured: 2 years

  6. 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.

    Measured: 2 years

  7. Adverse Events (Chemotherapy)

    Number of participants who experienced an adverse event related to their adjuvant chemotherapy

    Measured: 2 years

  8. 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.

    Measured: up to 5 years

  9. Blood Tests to Examine the Effects of Melatonin on the Immune System (Raw Values)

    NK cell cytotoxicity changes from baseline to 6 months

    Measured: 6 months

  10. Adverse Events (Radiation)

    Number of participants who experienced an adverse event related to their adjuvant radiation therapy

    Measured: 2 years

  11. Blood Tests to Examine the Effects of Melatonin on the Immune System (Comparison Between Groups)

    Differences in NK cell cytotoxicity between both arms

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2008 (estimated)
  2. Study startSep 2007
  3. Primary completion9 Mar 2017
  4. Study completion30 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
709 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00668707
Sponsor's protocol ID
2007077-01H
Acronym
AMPLCaRe
Status last verified
Jul 2021
First submitted
25 Apr 2008
Last updated
3 Aug 2021
Data monitoring committee
Yes

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.

    PubMed 16207291

  • 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.

    PubMed 22019490

  • 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.

    PubMed 33681747

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing melatonin in people with Non Small Cell Lung Cancer, run by The Canadian College of Naturopathic Medicine at 8 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lung Cancer Recurrence or Mortality - 2 Years (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00668707, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.

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