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Methylphenidate Study in Breast or Gastrointestinal Cancer Patients

This study has been terminated.
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00516269
First received: August 14, 2007
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Breast Cancer
Fatigue
Gastrointestinal Cancer
Drug: Methylphenidate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 Breast or Gastrointestinal Cancer Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Mean Difference Between Post-Methylphenidate and Post-Placebo Measurement [ Time Frame: At end of two 2-week treatment cycles (4 weeks total) ] [ Designated as safety issue: No ]
    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.


Enrollment: 42
Study Start Date: August 2004
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516269

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00516269     History of Changes
Other Study ID Numbers: ID00-372
Study First Received: August 14, 2007
Results First Received: September 18, 2012
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

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:
Breast Neoplasms
Fatigue
Gastrointestinal Neoplasms
Breast Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Neoplasms
Neoplasms by Site
Signs and Symptoms
Skin Diseases
Methylphenidate
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014