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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Ortho-McNeil Janssen Scientific Affairs, LLC |
| Information provided by: | 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. 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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| 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 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Methylphenidate then Placebo: Experimental |
Drug: Methylphenidate
18 mg By Mouth Daily x 2 Weeks
Drug: Placebo
Capsule By Mouth Daily x 2 Weeks
|
| Placebo then Methylphenidate: Experimental |
Drug: Methylphenidate
18 mg By Mouth Daily x 2 Weeks
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| Contact: Carmen Escalante, MD | 713-745-4516 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Carmen Escalante, MD | |
| Principal Investigator: | Carmen Escalante, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Carmen Escalante, MD/Professor ) |
| Study ID Numbers: | ID00-372 |
| Study First Received: | August 14, 2007 |
| Last Updated: | November 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00516269 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Breast Cancer Gastrointestinal Cancer GI Cancer Fatigue OROS Methylphenidate HCl |
Methylphenidate Methylphenidate Hydrochloride Concerta Ritalin Placebo |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Fatigue Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Skin Diseases Gastrointestinal Diseases Physiological Effects of Drugs Breast Neoplasms Methylphenidate |
Central Nervous System Stimulants Pharmacologic Actions Signs and Symptoms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Dopamine Agents Central Nervous System Agents Breast Diseases |