Trial Information
Melatonin for Fatigue and Other Symptoms in Patients With Advanced Cancer
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
Type of Study:
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
Outcome Measure:
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)
Outcome Time Frame:
One week
Safety Issue:
No
Principal Investigator
Lise Pedersen, MD, DMSc.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Palliative Medicine, Bispebjerg Hospital
Authority:
Denmark: Danish Medicines Agency
Study ID:
Feldt-01
NCT ID:
NCT00925899
Start Date:
October 2009
Completion Date:
March 2013
Related Keywords:
- Cancer
- Fatigue
- Melatonin
- Palliative care
- Advanced cancer
- Symptoms
- Quality of life
- Randomized controlled trial
- Fatigue
- Neoplasms