Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Cancer Patients
Condition: Breast Cancer; Fatigue; Gastrointestinal Cancer
MeSH terms: Gastrointestinal Neoplasms; Fatigue
Intervention: Methylphenidate; Placebo
Intervention description: 18 mg by mouth daily for 2 weeks; Capsule by mouth daily for 2 weeks
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Gastrointestinal Cancer; GI Cancer; Fatigue; OROS Methylphenidate HCl; Methylphenidate; Methylphenidate Hydrochloride; Concerta; Ritalin; Placebo

Summary:

      The goal of this clinical research study is to see if the drug OROS Methylphenidate HCl
      (Concerta) can help to control fatigue in patients with breast, gastrointestinal, lymphoma,
      myeloma or lung cancer who are going through chemotherapy or hormonal treatment or have
      completed chemotherapy or hormonal treatment in the last 12 months. The safety of this drug
      will also be studied. Another goal of the study is to see how certain cytokines change while
      patients undergo chemotherapy or hormonal treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient diagnosed with breast, gastrointestinal, lymphoma, myeloma or lung cancer
             undergoing chemotherapy or hormonal treatment

          2. Patient is > or = 18 years of age

          3. Patient has Brief Fatigue Inventory "fatigue worst" score of > or = 4 at baseline

          4. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of < or =
             2 at baseline

          5. Patient has a life expectancy > or = 6 months from the start of the study

          6. Patient is using acceptable birth control methods. Female participants (if of child
             bearing potential and sexually active) and male participants (if sexually active with
             a partner of child-bearing potential) must use medically acceptable methods of birth
             control. Medically acceptable methods of contraception include abstinence, birth
             control pills, diaphragm with spermicide, condom with foam or spermicide, vaginal
             spermicidal suppository or surgical sterilization

          7. Patient must speak and understand English

          8. Patient has provided written informed consent to participate in the study prior to
             enrollment to the study

        Exclusion Criteria:

          1. History of hypersensitivity reaction to methylphenidate

          2. History of or current seizure disorder, glaucoma, major psychiatric diagnosis,
             narcolepsy, Tourette's syndrome, tension or agitation

          3. History of clinically significant cardiac disease.

          4. Uncontrolled hypertension: has not been on a stable treatment dose for the past month,
             or has a systolic pressure consistently (defined as 3 consecutive blood pressure
             readings within the last 30 days) greater than 150 mm Hg or diastolic pressure
             consistently greater than 85 mm Hg

          5. History of fibromyalgia

          6. Use of alcohol while participating in the study

          7. Current use of illicit drugs or history of alcohol or drug abuse and/or abuse
             potential (see protocol for criteria)

          8. Moderate to severe depression (> or = 20 on Beck Depression Index II)

          9. If taking antidepressants, no changes in dose and/or no start of new course of
             treatment in the last 30 days

         10. Currently taking psychostimulants (including appetite suppressants), monoamine oxidase
             (MAO) inhibitors, anticoagulant or anticonvulsant therapy

         11. Current use of corticosteroids, medications, or stimulants (i.e., vivarin) used to
             improve fatigue symptoms

         12. Use of an investigational medication within the past month

         13. Current use of the following herbals or supplements for fatigue relief (DHEA, SAME,
             ginkgo, ginseng, St. John's Wort (including DHEA, SAME, ginkgo, ginseng, St. John's
             Wort, metabolite, effedrin, basil, citronella, fennel, horseradish roots, lavender
             flowers, lemon verbena, marjoram, mint, nettle, pine needles, rosemary, sage, savory,
             thyme, bay, cayenne pepper, cinnamon, eucalyptus, hyssop, myrrh, oregano, peppermint,
             ginseng, green, black or Chinese tea, ephedra (aka - ma-huang), popotillo, and Mormon
             tea)

         14. Any coexisting medical condition or are taking any concomitant medication that is
             likely to interfere with the safe administration of methylphenidate

         15. Patients who start epoetin within 30 days prior to enrollment

         16. Patients who start taking epoetin during the first week of the study

         17. Hemoglobin < 8.0 gm/dl

         18. Patients with a thyroid-stimulating hormone (TSH) value > or = 1.5 times the upper
             limit of normal (ULN)

         19. Albumin value 50% lower than the lower limit of normal

         20. Evidence of hepatic impairment [total bilirubin > or = 2.5 times ULN (normal range of
             0 - 1.0 mg/dl, serum glutamate pyruvate transaminase (SGPT) > or = 2.5 times ULN)]

         21. Evidence of renal impairment (serum creatinine > 2.5 times ULN, normal range of 0.8 -
             1.5 mg/dl)

         22. A severe narrowing (pathological or iatrogenic), obstruction of the gastrointestinal
             tract, or gastrointestinal malabsorption

         23. If taking anxiolytics, and/or hypnotics, no changes in dose and/or no start of new
             course of treatment in the last 30 days

         24. Patients with nausea, vomiting, or diarrhea of Common Toxicity Criteria for Adverse
             Effects (CTCAE) grade III or higher

         25. If taking anticonvulsants for sensory neuropathy (Gabapentin or Pregabalin), no
             changes in dose and/or no start of new course of treatment in the last 30 days

         26. History of severe headaches within 30 days prior to enrollment