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Melatonin for Fatigue and Other Symptoms in Patients With Advanced Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00925899
First Posted: June 22, 2009
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
I.M Daehnfeldt Foundation
Danish Cancer Society
Aase and Ejnar Danielsens Foundation
Beckett Foundation
The Andersen-Isted Foundation
Information provided by (Responsible Party):
Lise Pedersen, Bispebjerg Hospital
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 Lise Pedersen, 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 ]

    Primary outcome: Change from baseline to week one in intervention group minus change from baseline to week one in control group.

    Because it was a cross-over trial this was calculated the following way:

    Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).

    The physical fatigue scale conists of four item each ranging from one to five. The four item were summed and the scae was converted to 0 to 100, where 100 indicated maximum fatigue.



Secondary Outcome Measures:
  • Insomnia Measured by the Insomnia Item in the Questionnaire EORTC QLQ-C15-PAL [ Time Frame: One week ]

    Primary outcome: Change from baseline to week one in intervention group minus change from baseline to week one in control group.

    Because it was a cross-over trial this was calculated the following way:

    Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).

    Insomnia was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated maximum insomnia.


  • 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) [ Time Frame: One week ]

    Change from baseline to week one in intervention group minus change from baseline to week one in control group.

    Because it was a cross-over trial this was calculated the following way:

    Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).

    Emotional function was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated the best possible emotional function.

    Note outcome reported for complete compliers


  • 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 ]

    Change from baseline to week one in intervention group minus change from baseline to week one in control group.

    Because it was a cross-over trial this was calculated the following way:

    Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).

    Pain was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated maximum pain.

    Note outcome reported for complete compliers


  • 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 ]

    Change from baseline to week one in intervention group minus change from baseline to week one in control group.

    Because it was a cross-over trial this was calculated the following way:

    Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).

    Quality of Life was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated best possible quality of life.

    Note outcome reported for complete compliers


  • 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 ]

    Change from baseline to week one in intervention group minus change from baseline to week one in control group.

    Because it was a cross-over trial this was calculated the following way:

    Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).

    Appetite loss was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated maximum appetite loss (worst possible).

    Note outcome reported for complete compliers


  • General Fatigue Measured by the The Multidimensional Fatigue Inventory (MFI) [ Time Frame: One week ]

    Change from baseline to week one in intervention group minus change from baseline to week one in control group.

    Because it was a cross-over trial this was calculated the following way:

    Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).

    The general fatigue scale that consits of four items was converted to a 0 til 100 scale where 100 indicated maximum (worst possible) fatigue.

    Note outcome reported for complete compliers



Enrollment: 72
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925899


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

Publications:
Responsible Party: Lise Pedersen, MD, DMSc, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00925899     History of Changes
Other Study ID Numbers: Feldt-01
First Submitted: June 19, 2009
First Posted: June 22, 2009
Results First Submitted: October 28, 2016
Results First Posted: April 20, 2017
Last Update Posted: April 20, 2017
Last Verified: March 2017

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

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