Status:
COMPLETED
Methylphenidate in Treating Patients With Fatigue Caused by Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
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 to...
Eligibility Criteria
Inclusion
- ≥ 18 years of age
- Men or women with a history of cancer-related fatigue as defined by a score ≥ 4 on a fatigue numerical analogue scale (0 - 10)
- Fatigue for ≥ 1 month prior to registration
- ECOG Performance Score (PS) 0, 1, or 2
- Life expectancy ≥ 6 months
- Histologic or cytologic proven cancer other than brain cancer or CNS lymphoma
- Laboratory values obtained ≤ 30 days prior to registration:
- Hgb ≥ 10 g/dL
- Willing and able to provide informed consent
- Negative pregnancy test (urine or serum) done ≤ 7 days prior to registration, for women of childbearing potential only
- Ability to complete questionnaire(s) by themselves or with assistance
- Biological therapy (i.e. immunotherapy, biotherapy), chemotherapy or radiation therapy will be allowed
- Use of a stable dose of anti-depressants (except tricyclic anti-depressants) will be allowed
- Erythropoietic agents to treat anemia, and steroids as a part of cancer treatment and for symptom management (except for fatigue) will be allowed
Exclusion
- Hypersensitivity to methylphenidate
- Any prior use of methylphenidate
- Concomitant (≤ 2 weeks) use of prescription stimulants (pemoline, modafinil, amphetamines); other medications, herbal products or dietary supplements for fatigue
- Uncontrolled hypertension \[defined as systolic blood pressure (BP) ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg on 2 separate visits ≤ 2 months prior to randomization\]; or a resting heart rate \> 100
- Moderate or severe pain as defined by an average daily score ≥ 4 on a pain analog scale (0 - 10)
- Known brain metastasis or primary CNS malignancy
- Clinically significant acute or chronic progressive or unstable neurologic (dementia, delirium, or seizure disorder), hepatic, renal, cardiovascular, thyroid, or respiratory disease that would limit participation in the study per MD discretion or judgment
- Psychiatric disorder such as manic depression, anxiety disorder, bipolar disorder, obsessive compulsive disorder, or schizophrenia
- Major surgery \< 4 weeks prior to registration. (Note: Insertion of central venous catheter is not considered major surgery.)
- Using a drug contraindicated when taken concurrently with methylphenidate: coumarin anticoagulants, anticonvulsants, tricyclic antidepressants, antipsychotics, monoamine oxidase inhibitors, clonidine, theophylline, and pseudoephedrine
- Note: use of Compazine prescribed as an antiemetic is permitted for use while participating in this study.
- Additional medical conditions where use of methylphenidate is contraindicated:
- glaucoma, motor tics, family history or diagnosis of Tourette's syndrome, history of drug or alcohol abuse or intestinal obstruction.
- Pregnant women or nursing women. Women of childbearing potential who are unwilling to employ adequate contraception. This study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown.
- Untreated hypothyroidism (TSH ≥ 5)
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00376675
Start Date
February 1 2008
End Date
June 1 2010
Last Update
August 1 2016
Active Locations (238)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
3
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
4
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933