Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Cancer Patients

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Fatigue; Gastrointestinal Cancer	Drug: Methylphenidate; Drug: Placebo	Phase 3

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Study Design

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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

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Methylphenidate then Placebo; Methylphenidate 18 mg oral daily for 2 weeks then Placebo oral daily for 2 weeks	Drug: Methylphenidate; 18 mg by mouth daily for 2 weeks; Other Names: Concerta; Ritalin; Methylphenidate Hydrochloride 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: Concerta; Ritalin; Methylphenidate Hydrochloride Drug: Placebo; Capsule by mouth daily for 2 weeks

Outcome Measures

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Primary Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Ortho-McNeil Janssen Scientific Affairs, LLC

Investigators

Principal Investigator:	Carmen Escalante, MD	M.D. Anderson Cancer Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

The University of Texas M.D.Anderson Cancer Center 

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00516269 History of Changes
Other Study ID Numbers:	ID00-372
First Posted:	August 15, 2007
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

Keywords provided by M.D. Anderson Cancer Center:

Breast Cancer; Gastrointestinal Cancer; GI Cancer; Fatigue; OROS Methylphenidate HCl	Methylphenidate; Methylphenidate Hydrochloride; Concerta; Ritalin; Placebo

Additional relevant MeSH terms:

Fatigue; Gastrointestinal Neoplasms; Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; 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