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Long Acting Methylphenidate (Concerta™) for Cancer-Related Fatigue: A Phase III, Randomized, Double-Blind Placebo Controlled Study

Phase 3
18 Years
Not Enrolling
Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

Long Acting Methylphenidate (Concerta™) for Cancer-Related Fatigue: A Phase III, Randomized, Double-Blind Placebo Controlled Study



- Test the efficacy of long-acting methylphenidate in patients with cancer-related
fatigue as measured using an item of the Brief Fatigue Inventory.


- Evaluate the tolerability and adverse events associated with this drug in these

- Study the effect of this drug on quality of life (QOL)-related variables (vitality,
sleep quality, overall QOL, QOL domains, other fatigue measures, and perceived
treatment efficacy) in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to disease stage (0, I, or II vs III or IV), level of fatigue at
baseline (4-7 vs 8-10), concurrent biological therapy (yes vs no), concurrent chemotherapy
(yes vs no), and concurrent radiotherapy (yes vs no). Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive oral methylphenidate daily on days 1-28.

- Arm II: Patients receive oral placebo daily on days 1-28. Patients in both arms
complete questionnaires to assess their symptoms of fatigue, overall mood, quality of
life, sleep quality, and adverse effects from treatment at baseline and once weekly for
4 weeks. Patients also complete a Symptom Experience Diary.

PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed cancer, except for any of the following:

- Brain cancer, including primary CNS malignancy or brain metastases

- CNS lymphoma

- History of cancer-related fatigue, as defined by a score of ≥ 4 on a fatigue
numerical analogue scale (0-10)

- Has had fatigue for ≥ 1 month

- No moderate or severe pain, as defined by an average daily score ≥ 4 on a pain analog
scale (0-10)


- ECOG performance status 0-2

- Life expectancy ≥ 6 months

- Hemoglobin ≥ 10 g/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No hypersensitivity to methylphenidate

- No uncontrolled hypertension, defined as systolic blood pressure (BP) ≥ 160 mm Hg
and/or diastolic BP ≥ 100 mm Hg on 2 separate visits ≤ 2 months apart

- No resting heart rate > 100

- No clinically significant acute or chronic progressive or unstable neurologic
(dementia, delirium, or seizure disorder), hepatic, renal, cardiovascular, thyroid,
or respiratory disease that would preclude study participation

- No psychiatric disorder, including any of the following:

- Manic depression

- Anxiety disorder

- Bipolar disorder

- Obsessive compulsive disorder

- Schizophrenia

- None of the following medical conditions for which the use of methylphenidate is

- Glaucoma

- Motor tics

- Family history or diagnosis of Tourette's syndrome

- History of drug or alcohol abuse

- Intestinal obstruction

- No untreated hypothyroidism (i.e., thyroid-stimulating hormone ≥ 5)


- No prior methylphenidate

- More than 4 weeks since prior major surgery

- Insertion of a central venous catheter is not considered major surgery

- More than 2 weeks since prior and no concurrent prescription stimulants (e.g.,
pemoline, modafinil, or amphetamines) or other medications, herbal products, or
dietary supplements for fatigue

- No concurrent administration of any of the following:

- Coumarin anticoagulants

- Anticonvulsants

- Tricyclic antidepressants

- A stable dose of other antidepressants allowed

- Antipsychotics

- Monoamine oxidase inhibitors

- Clonidine

- Theophylline

- Pseudoephedrine

- Compazine prescribed as an antiemetic allowed

- Concurrent biological therapy, chemotherapy, or radiotherapy allowed

- Concurrent erythropoietic agents to treat anemia allowed

- Concurrent steroids as a part of cancer treatment and for symptom management (except
for fatigue) allowed

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Total fatigue as measured by the Brief Fatigue Inventory at baseline and at weeks 1-4

Safety Issue:


Principal Investigator

Amit Sood, MD

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

February 2008

Completion Date:

Related Keywords:

  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific
  • fatigue
  • unspecified adult solid tumor, protocol specific
  • Fatigue



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