deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT00668707

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

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

Sponsor: Gateway for Cancer Research

Updated 12 times since 2017 Last updated: Jul 12, 2021 Started: Sep 30, 2007 Primary completion: Mar 9, 2017 Completion: Nov 30, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Non Small Cell Lung Cancer, this trial is completed. The trial is conducted by Gateway for Cancer Research and has accumulated 12 data snapshots since 2007. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshotActive Not Recruiting~Jun 2017 – ~Jun 2018 · 12 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Apr 2019 · 10 months · monthly snapshotActive Not Recruiting~Apr 2019 – ~May 2020 · 13 months · monthly snapshotCompleted~May 2020 – ~Jan 2021 · 8 months · monthly snapshotCompleted~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotCompleted~Sep 2021 – ~Jul 2024 · 34 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

12 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Present [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Sep 2021 — Jul 2024 [monthly]

    Completed PHASE3

Show 7 earlier versions
  1. Jan 2021 — Sep 2021 [monthly]

    Completed PHASE3

  2. May 2020 — Jan 2021 [monthly]

    Completed PHASE3

  3. Apr 2019 — May 2020 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  4. Jun 2018 — Apr 2019 [monthly]

    Active Not Recruiting PHASE3

  5. Jun 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  6. Feb 2017 — Jun 2017 [monthly]

    Active Not Recruiting PHASE3

  7. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Sep 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Gateway for Cancer Research
  • Lotte & John Hecht Memorial Foundation
  • The Canadian College of Naturopathic Medicine
  • The Ottawa Hospital
Data source: The Canadian College of Naturopathic Medicine

For direct contact, visit the study record on ClinicalTrials.gov .