Methylphenidate in Treating Patients With Fatigue Caused by Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00376675
First received: September 13, 2006
Last updated: September 11, 2012
Last verified: November 2008
  Purpose

RATIONALE: Methylphenidate may help relieve fatigue caused by cancer. It is not yet known whether methylphenidate is more effective than a placebo in relieving fatigue and improving quality of life in patients with cancer.

PURPOSE: This randomized phase III trial is studying methylphenidate to see how well it works in treating patients with fatigue caused by cancer.


Condition Intervention Phase
Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Drug: methylphenidate hydrochloride
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: Long Acting Methylphenidate (Concerta™) for Cancer-Related Fatigue: A Phase III, Randomized, Double-Blind Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Total fatigue as measured by the Brief Fatigue Inventory at baseline and at weeks 1-4 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events and tolerability as measured by the Symptom Experience Diary and the CTCAE [ Designated as safety issue: Yes ]
  • Sleep quality as measured by the Pittsburgh Sleep Quality Index [ Designated as safety issue: No ]
  • Vitality as measured by the Short Form-36 Vitality Subscale [ Designated as safety issue: No ]
  • Overall quality of life (QOL) and QOL domains as measured by the Linear Analogue Self Assessment [ Designated as safety issue: No ]
  • Perceived treatment efficacy as measured by the Subject Global Impression of Change [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: February 2008
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral methylphenidate daily on days 1-28.
Drug: methylphenidate hydrochloride
Given orally
Placebo Comparator: Arm II
Patients receive oral placebo daily on days 1-28.
Other: placebo
Given orally

Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • Evaluate the tolerability and adverse events associated with this drug in these patients.
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

  • 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 contraindicated:

    • 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)

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376675

  Show 240 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Investigator: Amit Sood, MD Mayo Clinic
Investigator: Shaker R. Dakhil, MD, FACP Cancer Center of Kansas, PA - Wichita
Investigator: Charles L. Loprinzi, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Charles L. Loprinzi, North Central Cancer Treatment Group
ClinicalTrials.gov Identifier: NCT00376675     History of Changes
Other Study ID Numbers: CDR0000495148, NCCTG-N05C7
Study First Received: September 13, 2006
Last Updated: September 11, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
fatigue
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014