Phase 3
Completed N=72
Melatonin for Fatigue and Other Symptoms in Patients With Advanced Cancer
Source: ClinicalTrials.gov NCT00925899 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Fatigue as Measured by the Physical Fatigue Scale in the The Multidimensional Fatigue Inventory (MFI) (Smets EM, Garssen B, Bonke B, et al., J Psychosom Res 39:315-325, 1995) — -1.1; -3.9 units on a scale
◆ Published Evidence
Established
49citations · ~4 / year
Effects of melatonin on physical fatigue and other symptoms in patients with advanced cancer receiving palliative care: A double-blind placebo-controlled crossover trial.
Summary
BACKGROUND:
Patients with advanced cancer often suffer from fatigue and other symptoms and problems such as insomnia, appetite loss and pain. Problems that may have great consequences for their quality of life. Several studies suggest that a supplement of the hormone melatonin (MLT) may have a beneficial effect on these symptoms/problems. This needs further investigation.
AIM:
To investigate if a supplement of melatonin have an effect on a) fatigue (the primary outcome of the trial), b) the symptoms insomnia, appetite loss, depression and pain, and c) overall quality of life.
METHODS AND PATIENTS:
The trial takes place in the Department of Palliative Medicine, Bispebjerg Hospital, and 50 patients will participate. The participants have to be 18 years or above, have advanced cancer, and suffer from quite a bit or very much fatigue.
The study consists of two parts. In part I it is investigated if melatonin has a better effect than placebo on the outcomes mentioned above. This part is a consecutive, prospective, double blinded, randomized (MLT vs. placebo), cross-over study where the patients serve as their own control. In part II the effect of melatonin over time is investigated. Part II is a consecutive, prospective, open-label study.
The outcomes are assessed with weekly questionnaires (MFI-20 and EORTC QLQ-C15PAL) and a few daily diary questions.
Melatonin has been used in several studies, and the general conclusion is that it is a safe substance with few adverse drug reactions.
PERSPECTIVES:
If melatonin has the potential to alleviate fatigue and other symptoms in patients with advanced cancer and enhance the quality of life of these patients, this will be of benefit to many future patients. Trials such as this are important both nationally and internationally to develop an evidence-based palliative medicine.
Linked Publications
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Effects of melatonin on physical fatigue and other symptoms in patients with advanced cancer receiving palliative care: A double-blind placebo-controlled crossover trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fatigue as Measured by the Physical Fatigue Scale in the The Multidimensional Fatigue Inventory (MFI) (Smets EM, Garssen B, Bonke B, et al., J Psychosom Res 39:315-325, 1995) |
-1.1; -3.9 | — |
| SECONDARY Insomnia Measured by the Insomnia Item in the Questionnaire EORTC QLQ-C15-PAL |
-9.9; -4.6 | — |
| SECONDARY Emotional Function as Measured by the Questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006) |
-0.6; 3.3 | — |
| SECONDARY Pain as Measured by the Questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006) |
0.8; 1.9 | — |
| SECONDARY Quality of Life as Measured by the Questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006) |
-0.8; -3.2 | — |
| SECONDARY Appetite Loss as Measured by the Questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006) |
-0.8; -3.2 | — |
| SECONDARY General Fatigue Measured by the The Multidimensional Fatigue Inventory (MFI) |
-3.2; -2.1 | — |
Eligibility Criteria
Inclusion Criteria
- Answered "quite a bit" or "very much" to the question "were you tired?" (from EORTC QLQ-C15-PAL)
- Cancer in a palliative phase
- Written informed consent
- Age 18 years or above
Exclusion Criteria
- Not capable of understanding or judging information, or fill out a questionnaire
- Untreated anemia (Hb 5.50 mcL/mL
- Pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT00925899) 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.