Methylphenidate in Treating Patients With Fatigue Caused by Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT00376675

Run by

Alliance for Clinical Trials in Oncology

People needed

148

Starts

2008-02-01

Expected to finish

2010-06-01

Last updated by the study team

2016-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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)

Where it is running

• Aurora Presbyterian Hospital — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
• St. Anthony Central Hospital — Denver, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
• St. Joseph Hospital — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• CCOP - Colorado Cancer Research Program — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center — Grand Junction, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Hope Cancer Care Center at Longmont United Hospital — Longmont, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• St. Mary - Corwin Regional Medical Center — Pueblo, Colorado, United States
• North Suburban Medical Center — Thornton, Colorado, United States
• Exempla Lutheran Medical Center — Wheat Ridge, Colorado, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• MBCCOP - Medical College of Georgia Cancer Center — Augusta, Georgia, United States
• Rush-Copley Cancer Care Center — Aurora, Illinois, United States
• St. Joseph Medical Center — Bloomington, Illinois, United States
• Graham Hospital — Canton, Illinois, United States
• Memorial Hospital — Carthage, Illinois, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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