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.
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.
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.