Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Melatonin for Fatigue and Other Symptoms in Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborators:
I.M Daehnfeldt Foundation
Danish Cancer Society
The Aase and Ejnar Danielsens Foundation
The Beckett Foundation
The Andersen-Isted Foundation
Information provided by (Responsible Party):
Lise Pedersen, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00925899
First received: June 19, 2009
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Cancer
Fatigue
Drug: Melatonin
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Melatonin for Fatigue and Other Symptoms in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • 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) [ Time Frame: One week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: One week ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: One week ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: One week ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: One week ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: One week ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: One week ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: October 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melatonin
20 mg
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 Comparator: Placebo 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925899

Locations
Denmark
Department of Palliative Medicine, Bispebjerg Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
I.M Daehnfeldt Foundation
Danish Cancer Society
The Aase and Ejnar Danielsens Foundation
The Beckett Foundation
The Andersen-Isted Foundation
Investigators
Principal Investigator: Lise Pedersen, MD, DMSc. Department of Palliative Medicine, Bispebjerg Hospital
  More Information

No publications provided

Responsible Party: Lise Pedersen, MD, DMSc, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00925899     History of Changes
Other Study ID Numbers: Feldt-01
Study First Received: June 19, 2009
Last Updated: May 15, 2013
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Bispebjerg Hospital:
Melatonin
Palliative care
Advanced cancer
Symptoms
Quality of life
Randomized controlled trial

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Melatonin
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014