A Randomized, Double-Blind, Two-Period, Placebo-Controlled Crossover Trial of Sustained-Release Methylphenidate in the Treatment of Fatigue in Breast Cancer Patients
Principal Investigator: Carmen Escalante, M.D.
Disabling fatigue is the most frequently reported symptom of cancer patients. This protocol is testing the effectiveness of sustained release methylphenidate in the treatment of fatigue in breast cancer patients undergoing chemotherapy.
- To assess the efficacy of OROS® Methylphenidate as compared to placebo for improvement of fatigue in patients with metastatic breast cancer who are undergoing chemotherapy with taxotere
- To examine cytokine levels and their correlation with fatigue and cognitive function
Outpatients currently undergoing chemotherapy for solid tumors will be recruited for this study and randomly assigned to one of the following treatment arms:
- Patients randomized to Arm 1 will take 18 mg of OROS® Methylphenidate every morning for the first 14 day treatment period.
- Patients randomized to Arm 2 take a placebo every morning for the first 14-day treatment period.
Once patients complete week 2 of the first assigned treatment they will crossover to the other treatment arm. At the end of the second treatment period of the study, patients will be asked if they prefer the first (first two weeks of study) or second (second two weeks of study) treatment phase. Those patients who want to continue taking the OROS® Methylphenidate will be allowed to do so off-study if they desire and if there are no medical contraindications.
Measures include the Beck Depression Inventory, Brief Fatigue Inventory, Brief Sleep Disturbance Scale, ECOG Performance Status, MD Anderson Symptom Inventory, Profile of Mood States, electrocardiogram, lab draws for CBC and cytokines and neurocognitive testing.
For more information
Contact Beth Johnson, R.N., at firstname.lastname@example.org