Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific, fatigue
Brief summary
RATIONALE: Methylphenidate may relieve some of the side effects of chemotherapy in patients with melanoma. It is not known whether receiving methylphenidate is more effective than receiving no further therapy in treating patients with melanoma. PURPOSE: Randomized phase III trial to determine if methylphenidate is more effective than no further therapy for the relief of fatigue and drowsiness in treating patients with melanoma who have received high-dose interferon alfa for 8-24 weeks.
Detailed description
OBJECTIVES: I. Determine whether methylphenidate decreases fatigue and lethargy in cancer patients receiving interferon alfa. II. Determine whether the use of methylphenidate in this patient population decreases the number of dose reductions of interferon alfa due to toxicities other than myelosuppression or elevated liver function tests. III. Assess whether efficacy or toxicity of methylphenidate in this patient population is concentration dependent. IV. Compare the fatigue subscale and the proposed Brief Fatigue Inventory. OUTLINE: This is a randomized, double-blind, placebo-controlled, two arm study. Patients are stratified according to initial fatigue level (high vs moderate), and treatment with tumor vaccine (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral methylphenidate twice daily. Arm II: Patients receive oral placebo twice daily. Treatment is continued for 21 consecutive days with dose escalations as tolerated and as needed by patient judgement, followed by an additional week to evaluate the effect of drug withdrawal. Patients are contacted by telephone at least twice weekly during the 21 day treatment and 7 day washout phase to assess adverse or rebound effects. Before the study begins and at weekly clinic visits for the 4 week study period, patients complete a series of questionnaires to measure mood, levels of fatigue and lethargy, and sense of well being. Patients also keep a short daily diary of study medication doses and degree of tiredness. Patients are followed every 3 months for 2 years, then every 6 months for the next 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 200 patients will be accrued into this study within 39 months.
Interventions
DRUGmethylphenidate hydrochloride
PROCEDUREquality-of-life assessment
Sponsors
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: On interferon alfa-2b treatment for at least 8 weeks Dose must be stable for 2 weeks prior to and during study Fatigue level at least 4 on the Symptom and Fatigue Self Evaluation Form (0 none, 10 worst possible) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: More than 4 weeks Hematopoietic: Hematocrit at least 30% Hepatic: Not specified Renal: Creatinine no greater than 2.0 mg/dL Other: No history of any of the following: Chronic use of anticonvulsants Seizure disorder Motor tics Glaucoma Family history or diagnosis of Tourette's disorder No allergic reaction or hypersensitivity to methylphenidate Cognitively able to participate Not incarcerated Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics No monoamine oxidase inhibitors within 2 months
Countries
Puerto Rico, South Africa, United States
Outcome results
None listed