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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Ortho-McNeil Janssen Scientific Affairs, LLC |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00516269 |
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 III |
| 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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2004 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Methylphenidate then Placebo |
Drug: Methylphenidate
18 mg By Mouth Daily x 2 Weeks
Other Names:
Drug: Placebo
Capsule By Mouth Daily x 2 Weeks
|
| Experimental: Placebo then Methylphenidate |
Drug: Methylphenidate
18 mg By Mouth Daily x 2 Weeks
Other Names:
Drug: Placebo
Capsule By Mouth Daily x 2 Weeks
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Carmen Escalante, MD | M.D. Anderson Cancer Center |
More Information
| 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 |
| Last Updated: | September 26, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Breast Cancer Gastrointestinal Cancer GI Cancer Fatigue OROS Methylphenidate HCl |
Methylphenidate Methylphenidate Hydrochloride Concerta Ritalin Placebo |
|
Breast Neoplasms Fatigue Gastrointestinal Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Signs and Symptoms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Methylphenidate Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |