Methylphenidate in Treating Patients With Fatigue Caused by Cancer - Full Text View

Sponsors and Collaborators:	North Central Cancer Treatment Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00376675

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 Drug: placebo	Phase III

MedlinePlus related topics: Cancer

Drug Information available for: Methylphenidate hydrochloride Methylphenidate

U.S. FDA Resources

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

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
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive oral methylphenidate daily on days 1-28.	Drug: methylphenidate hydrochloride Given orally
Arm II: Placebo Comparator Patients receive oral placebo daily on days 1-28.	Drug: 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

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

Show 244 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

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

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000495148, NCCTG-N05C7
Study First Received:	September 13, 2006
Last Updated:	December 25, 2008
ClinicalTrials.gov Identifier:	NCT00376675
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

fatigue
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Signs and Symptoms
Dopamine
Fatigue
Methylphenidate

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Physiological Effects of Drugs
Central Nervous System Stimulants
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009