Phase 3
Completed N=709
Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality
Source: ClinicalTrials.gov NCT00668707 ↗Enrolled (actual)
709
Serious AEs
24.4%
Results posted
Aug 2021
Primary outcomePrimary: Lung Cancer Recurrence or Mortality - 2 Years — 80; 85 Participants — p=0.94
◆ Published Evidence
Established
48citations · ~10 / year
Adjuvant melatonin for the prevention of recurrence and mortality following lung cancer resection (AMPLCaRe): A randomized placebo controlled 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.
Linked Publications
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Adjuvant melatonin for the prevention of recurrence and mortality following lung cancer resection (AMPLCaRe): A randomized placebo controlled clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lung Cancer Recurrence or Mortality - 2 Years |
80; 85 | 0.94 |
| SECONDARY Quality of Life |
21.4; 20.3; 18.2; 17.0; 17.3; 15.8 | 0.36 |
| SECONDARY Fatigue |
59.8; 57.0; 61.4; 62.4; 62.7; 63.1 | 0.13 |
| SECONDARY Sleep |
56.7; 53.8; 60.9; 61.5; 59.4; 60.5 | 0.18 |
| SECONDARY Pain Levels |
2.4; 2.3; 2.3; 2.4 | — |
| SECONDARY Anxiety |
8.2; 8.3; 6.2; 6.4 | — |
| SECONDARY Depression |
8.1; 8.6; 6.6; 7.7 | — |
| SECONDARY Adverse Events (Chemotherapy) |
44; 48 | 0.62 |
| SECONDARY Lung Cancer Recurrence or Mortality - 5 Years |
133; 130; 109; 99; 23; 31 | 0.41 |
| SECONDARY Blood Tests to Examine the Effects of Melatonin on the Immune System (Raw Values) |
49.8; 42.7; 49.2; 46.4 | 0.95 |
| SECONDARY Adverse Events (Radiation) |
8; 5 | 0.37 |
| SECONDARY Blood Tests to Examine the Effects of Melatonin on the Immune System (Comparison Between Groups) |
1.1; 1.16 | 0.34 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00668707) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.