Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Cancer Patients
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ClinicalTrials.gov Identifier: NCT00516269 |
Recruitment Status :
Terminated
(Slow Accrual)
First Posted : August 15, 2007
Results First Posted : April 26, 2013
Last Update Posted : January 3, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Fatigue Gastrointestinal Cancer | Drug: Methylphenidate Drug: Placebo | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double Blind, Two Period, Placebo-Controlled Crossover Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Cancer Patients |
Study Start Date : | August 2004 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Methylphenidate then Placebo
Methylphenidate 18 mg oral daily for 2 weeks then Placebo oral daily for 2 weeks
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Drug: Methylphenidate
18 mg by mouth daily for 2 weeks
Other Names:
Drug: Placebo Capsule by mouth daily for 2 weeks |
Experimental: Placebo then Methylphenidate
Placebo oral daily for 2 weeks then Methylphenidate 18 mg oral daily for 2 weeks
|
Drug: Methylphenidate
18 mg by mouth daily for 2 weeks
Other Names:
Drug: Placebo Capsule by mouth daily for 2 weeks |
- Mean Difference Between Post-Methylphenidate and Post-Placebo Measurement [ Time Frame: At end of two 2-week treatment cycles (4 weeks total) ]The primary endpoint is the "fatigue worst" score (range: 0 - 10) on the Brief Fatigue Inventory (BFI) at the end of two-week treatment (either Methylphenidate or placebo). "Worst fatigue" is defined as participants' rating of worst fatigue on a scale of 0 (no fatigue) to 10 (as bad as can imagine). Since each participant is expected to receive both 2-week of Methylphenidate or 2-week placebo at different times, they serve as their own control. The outcome is the difference in "fatigue worst" score between post-Methylphenidate measurement and post-Placebo measurement.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient diagnosed with breast, gastrointestinal, lymphoma, myeloma or lung cancer undergoing chemotherapy or hormonal treatment
- Patient is > or = 18 years of age
- Patient has Brief Fatigue Inventory "fatigue worst" score of > or = 4 at baseline
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of < or = 2 at baseline
- Patient has a life expectancy > or = 6 months from the start of the study
- 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
- Patient must speak and understand English
- Patient has provided written informed consent to participate in the study prior to enrollment to the study
Exclusion Criteria:
- History of hypersensitivity reaction to methylphenidate
- History of or current seizure disorder, glaucoma, major psychiatric diagnosis, narcolepsy, Tourette's syndrome, tension or agitation
- History of clinically significant cardiac disease.
- 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
- History of fibromyalgia
- Use of alcohol while participating in the study
- Current use of illicit drugs or history of alcohol or drug abuse and/or abuse potential (see protocol for criteria)
- Moderate to severe depression (> or = 20 on Beck Depression Index II)
- If taking antidepressants, no changes in dose and/or no start of new course of treatment in the last 30 days
- Currently taking psychostimulants (including appetite suppressants), monoamine oxidase (MAO) inhibitors, anticoagulant or anticonvulsant therapy
- Current use of corticosteroids, medications, or stimulants (i.e., vivarin) used to improve fatigue symptoms
- Use of an investigational medication within the past month
- 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)
- Any coexisting medical condition or are taking any concomitant medication that is likely to interfere with the safe administration of methylphenidate
- Patients who start epoetin within 30 days prior to enrollment
- Patients who start taking epoetin during the first week of the study
- Hemoglobin < 8.0 gm/dl
- Patients with a thyroid-stimulating hormone (TSH) value > or = 1.5 times the upper limit of normal (ULN)
- Albumin value 50% lower than the lower limit of normal
- 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)]
- Evidence of renal impairment (serum creatinine > 2.5 times ULN, normal range of 0.8 - 1.5 mg/dl)
- A severe narrowing (pathological or iatrogenic), obstruction of the gastrointestinal tract, or gastrointestinal malabsorption
- If taking anxiolytics, and/or hypnotics, no changes in dose and/or no start of new course of treatment in the last 30 days
- Patients with nausea, vomiting, or diarrhea of Common Toxicity Criteria for Adverse Effects (CTCAE) grade III or higher
- 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
- History of severe headaches within 30 days prior to enrollment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516269
United States, Texas | |
UT MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Carmen Escalante, MD | M.D. Anderson Cancer Center |
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00516269 |
Other Study ID Numbers: |
ID00-372 |
First Posted: | August 15, 2007 Key Record Dates |
Results First Posted: | April 26, 2013 |
Last Update Posted: | January 3, 2018 |
Last Verified: | December 2017 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Breast Cancer Gastrointestinal Cancer GI Cancer Fatigue OROS Methylphenidate HCl |
Methylphenidate Methylphenidate Hydrochloride Concerta Ritalin Placebo |
Gastrointestinal Neoplasms Fatigue Neoplasms by Site Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Methylphenidate |
Central Nervous System Stimulants Physiological Effects of Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents |