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

NCT00516269 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: ID00-372
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Fatigue; Gastrointestinal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean Difference Between Post-Methylphenidate and Post-Placebo Measurement

  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.

  At end of two 2-week treatment cycles (4 weeks total)

Study Arms (2)

Methylphenidate then Placebo

EXPERIMENTAL

Methylphenidate 18 mg oral daily for 2 weeks then Placebo oral daily for 2 weeks

Drug: Methylphenidate; Drug: Placebo

Placebo then Methylphenidate

EXPERIMENTAL

Placebo oral daily for 2 weeks then Methylphenidate 18 mg oral daily for 2 weeks

Drug: Methylphenidate; Drug: Placebo

Interventions

Methylphenidate DRUG

18 mg by mouth daily for 2 weeks

Also known as: Concerta, Ritalin, Methylphenidate Hydrochloride

Methylphenidate then Placebo; Placebo then Methylphenidate

Placebo DRUG

Capsule by mouth daily for 2 weeks

Methylphenidate then Placebo; Placebo then Methylphenidate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Gastrointestinal Neoplasms

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination due to slow accrual.

Results Point of Contact

• Title: Carmen Escalante, MD / Professor
• Organization: UT MD Anderson Cancer Center

RABaker@mdanderson.org

Study Officials

• Carmen Escalante, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2007
• First Posted: August 15, 2007
• Study Start: August 1, 2004
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 3, 2018
• Results First Posted: April 26, 2013

Record last verified: 2017-12

Locations

US (1)