Melatonin for Fatigue and Other Symptoms in Patients With Advanced Cancer

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bispebjerg Hospital
• Collaborators: Aase and Ejnar Danielsens Foundation; Beckett Foundation; Danish Cancer Society; I.M Daehnfeldt Foundation; The Andersen-Isted Foundation
• Treatments: Melatonin

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 <= 6,0 mmol/L)

• Untreated hypocalcaemia

• Systolic blood pressure < 100

• In treatment with coumadin

• Receiving unstable doses of methylphenidate, corticosteroids or sleeping medicine the past two weeks

• TSH < 0.50 or > 5.50 mcL/mL

• Pregnant or breast feeding