Phase 3
N=709
Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality
Non Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00668707 ↗Enrolled (actual)
709
Serious AEs
24.4%
Results posted
Aug 2021
Primary outcome: Primary: Lung Cancer Recurrence or Mortality - 2 Years — 80; 85 Participants — p=0.94
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- melatonin (Dietary_supplement); placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Canadian College of Naturopathic Medicine
- Primary completion
- Mar 2017
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 |
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.
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). 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.