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Melatonin for Fatigue and Other Symptoms in Patients With Advanced Cancer


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Cancer, Fatigue

Thank you

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

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