Melatonin for Fatigue and Other Symptoms in Patients With Advanced Cancer

NCT00925899 | Completed Phase 2 Results DMC

• 1 other identifier: Feldt-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

Melatonin; Palliative care; Advanced cancer; Symptoms; Quality of life; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  One week

Secondary Outcomes (6)

• Insomnia Measured by the Insomnia Item in the Questionnaire EORTC QLQ-C15-PAL

  One week

• 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)

  One week

• 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

• 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

• 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

Study Arms (2)

Melatonin

EXPERIMENTAL

20 mg

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Melatonin 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.

Melatonin

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• I.M Daehnfeldt Foundation: collaborator
• Danish Cancer Society: collaborator
• Aase and Ejnar Danielsens Foundation: collaborator
• Beckett Foundation: collaborator
• The Andersen-Isted Foundation: collaborator

Study Sites (1)

Department of Palliative Medicine, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (1)

• 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.

  PMID: 26178160 RESULT

MeSH Terms

Conditions

Neoplasms; Fatigue

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Lise Pedersen
• Organization: Bispebjerg Hospital

lise.pedersen.01@regionh.dk

004535312305

Study Officials

• Lise Pedersen, MD, DMSc.

  Department of Palliative Medicine, Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DMSc

Study Record Dates

• First Submitted: June 19, 2009
• First Posted: June 22, 2009
• Study Start: October 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 20, 2017
• Results First Posted: April 20, 2017

Record last verified: 2017-03

Locations

DK (1)