Melatonin for Fatigue and Other Symptoms in Patients With Advanced Cancer

NCT ID: NCT00925899

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2013-03-31

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.

Conditions

Cancer; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Melatonin

20 mg

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DRUG

20 mg melatonin orally every evening about 1 hour before bedtime for one week. After having participated in the cross-over part of the trial (one week of melatonin followed by one week of placebo, or the other way around), the participant may receive melatonin for 6 weeks.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet orally every evening about one hour before bedtime for one week. After having participated in the cross-over part of the trial (one week of placebo followed by one week of melatonin, or the other way around), the participant may receive melatonin for 6 weeks.

Interventions

Melatonin

20 mg melatonin orally every evening about 1 hour before bedtime for one week. After having participated in the cross-over part of the trial (one week of melatonin followed by one week of placebo, or the other way around), the participant may receive melatonin for 6 weeks.

Intervention Type: DRUG

Placebo

Placebo tablet orally every evening about one hour before bedtime for one week. After having participated in the cross-over part of the trial (one week of placebo followed by one week of melatonin, or the other way around), the participant may receive melatonin for 6 weeks.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.M Daehnfeldt Foundation

UNKNOWN

Sponsor Role: collaborator

Danish Cancer Society

OTHER

Sponsor Role: collaborator

Aase and Ejnar Danielsens Foundation

OTHER

Sponsor Role: collaborator

Beckett Foundation

OTHER

Sponsor Role: collaborator

The Andersen-Isted Foundation

UNKNOWN

Sponsor Role: collaborator

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lise Pedersen

MD, DMSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lise Pedersen, MD, DMSc.

Role: PRINCIPAL_INVESTIGATOR

Department of Palliative Medicine, Bispebjerg Hospital

Locations

Department of Palliative Medicine, Bispebjerg Hospital

Copenhagen, , Denmark

Countries

Denmark

References

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.

Reference Type: RESULT

PMID: 26178160 (View on PubMed)

Other Identifiers

Feldt-01

Identifier Type: -

Identifier Source: org_study_id