Melatonin for Fatigue and Other Symptoms in Patients With Advanced Cancer

Cancer Clinical Trial

Official title:

Melatonin for Fatigue and Other Symptoms in Patients With Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925899
• Other study ID #: Feldt-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 19, 2009
• Last updated: May 15, 2013
• Start date: October 2009
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Fatigue

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Denmark	Department of Palliative Medicine, Bispebjerg Hospital	Copenhagen

Sponsors (6)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Aase and Ejnar Danielsens Foundation, Beckett Foundation, Danish Cancer Society, I.M Daehnfeldt Foundation, The Andersen-Isted Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)		One week	No
Secondary	Insomnia as measured by the insomnia item in the questionnaire EORTC QLQ-C15-PAL and as measured by an item developed specifically for this study		One week	No
Secondary	Depression as measured by the questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006)		One week	No
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)		One week	No
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)		One week	No
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)		One week	No
Secondary	Fatigue measured by the four other scales in the The Multidimensional Fatigue Inventory (MFI): the general and mental fatigue scale, the reduced activity and reduced motivation scale, and as measured by an item developed specifically for this study		One week	No