Clinical trial NCT00925899: Melatonin for Fatigue and Other Symptoms in Patients With Advanced Cancer
Official title: Melatonin for Fatigue and Other Symptoms in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cancer
Fatigue
Keywords: Melatonin
Palliative care
Advanced cancer
Symptoms
Quality of life
Randomized controlled trial
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: I.M Daehnfeldt Foundation
name: Danish Cancer Society
name: Aase and Ejnar Danielsens Foundation
name: Beckett Foundation
name: The Andersen-Isted Foundation
First posted: 2009-06-22
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


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 \<= 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

Primary outcomes:
measure: 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)
timeFrame: One week
Secondary outcomes:
measure: Insomnia Measured by the Insomnia Item in the Questionnaire EORTC QLQ-C15-PAL
timeFrame: One week
measure: 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)
timeFrame: One week
measure: 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)
timeFrame: One week
measure: 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)
timeFrame: One week
measure: 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)
timeFrame: One week
measure: General Fatigue Measured by the The Multidimensional Fatigue Inventory (MFI)
timeFrame: One week
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Palliative Medicine, Bispebjerg Hospital
Study officials:
affiliation: Department of Palliative Medicine, Bispebjerg Hospital
name: Lise Pedersen, MD, DMSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lund Rasmussen C, Klee Olsen M, Thit Johnsen A, Petersen MA, Lindholm H, Andersen L, Villadsen B, Groenvold M, Pedersen L. Effects of melatonin on physical fatigue and other symptoms in patients with advanced cancer receiving palliative care: A double-blind placebo-controlled crossover trial. Cancer. 2015 Oct 15;121(20):3727-36. doi: 10.1002/cncr.29563. Epub 2015 Jul 15.