D-MPH in the Treatment of Fatigue and Neurobehavioral Function Related to Chemotherapy in Adult Cancer Patients
This study has been completed.
Sponsor:
Celgene Corporation
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00047476
First received: October 8, 2002
Last updated: June 23, 2005
Last verified: May 2004
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To evaluate the efficacy of dexmethylphenidate (d-MPH) in the treatment of chemotherapy-related fatigue in adult cancer subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Fatigue Neoplasms |
Drug: dexmethylphenidate(d-mph) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of d-MPH in the Treatment of Fatigue and Neurobehavioral Impairment Related to Chemotherapy in Adult Cancer Patients |
Resource links provided by NLM:
Further study details as provided by Celgene Corporation:
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- Diagnosis of cancer, excluding primary or metastatic brain tumors.
- Treated with a minimum of four cycles of a cytotoxic chemotherapy, the last chemotherapy treatment must have been completed at least 2 months prior to study entry.
- Physical/neurological examination consistent with the absence of a focal neurological deficit
- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
- Subjects must be able to adhere to the protocol requirements.
- Subjects must understand and voluntarily sign an informed consent document.
- Subjects must be a native English speaker or fluent in English, and have at least an eighth grade education.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047476
Locations
| United States, Alabama | |
| Cooper Green Hospital, Jefferson Clinic | |
| Birmingham, Alabama, United States, 35233 | |
| University of Alabama Palliative Care Institute | |
| Birmingham, Alabama, United States, 35294-0023 | |
| United States, Arizona | |
| Peak Performance Wellness | |
| Flagstaff, Arizona, United States, 86004 | |
| Arizona Clinical Research Center | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Alta Bates Comprehensive Cancer Center | |
| Berkeley, California, United States, 94704 | |
| California Cancer Care Inc | |
| Greenbrae, California, United States, 94904-2007 | |
| Clinical Trials and Research Associates | |
| Montebello, California, United States, 90640 | |
| Comprehensive Cancer Centers of the Desert | |
| Palm Springs, California, United States, 92262 | |
| United States, Florida | |
| Comprehensive Cancer Center | |
| Boca Raton, Florida, United States, 33428 | |
| Osler Clinical Research/Osler Medical Inc | |
| Melbourne, Florida, United States, 32901 | |
| University of Miami, Sylvester Cancer Research Center | |
| Miami, Florida, United States, 33139 | |
| Cancer Research Network Inc | |
| Plantation, Florida, United States, 33324 | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33162 | |
| United States, Georgia | |
| Piedmont Hospital | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Kentucky | |
| Markey Cancer Center | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Maryland | |
| Sinai Hospital of Baltimore | |
| Baltimore, Maryland, United States, 21215 | |
| United States, New York | |
| Beth Israel Cancer Center | |
| New York, New York, United States, 10003 | |
| United States, South Carolina | |
| Gynecologic Oncology Associates and Development LLC | |
| Greenville, South Carolina, United States, 29604 | |
| United States, Washington | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109-1023 | |
| Northwest Medical Specialists, PLLC | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| UW Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
Sponsors and Collaborators
Celgene Corporation
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00047476 History of Changes |
| Obsolete Identifiers: | NCT00052533 |
| Other Study ID Numbers: | d-MPH-COG-002 |
| Study First Received: | October 8, 2002 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Celgene Corporation:
|
neurobehavioral function chemobrain chemo brain fatigue |
memory loss exhausted trouble concentrating |
Additional relevant MeSH terms:
|
Neoplasms Fatigue Signs and Symptoms 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 |
ClinicalTrials.gov processed this record on June 18, 2013