FatiguePhase 2NCT00047476
D-MPH in the Treatment of Fatigue and Neurobehavioral Function Related to Chemotherapy in Adult Cancer Patients
A Phase 2 study testing dexmethylphenidate(d-mph) in people with Fatigue and Neoplasms, run by Celgene Corporation at 21 sites in United States.
Trial summary
To evaluate the efficacy of dexmethylphenidate (d-MPH) in the treatment of chemotherapy-related fatigue in adult cancer subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- dexmethylphenidate(d-mph)
- How many people
- 160 participants
- Where
- 21 sitesUnited States
- Study dates
- Jun 2002to Mar 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Piedmont Hospital
Atlanta, Georgia, 30309
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
Cooper Green Hospital, Jefferson Clinic
Birmingham, Alabama, 35233
University of Alabama Palliative Care Institute
Birmingham, Alabama, 35294-0023
Comprehensive Cancer Center
Boca Raton, Florida, 33428
Peak Performance Wellness
Flagstaff, Arizona, 86004
California Cancer Care Inc
Greenbrae, California, 94904-2007
Gynecologic Oncology Associates and Development LLC
Greenville, South Carolina, 29604
Markey Cancer Center
Lexington, Kentucky, 40536
UW Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
Osler Clinical Research/Osler Medical Inc
Melbourne, Florida, 32901
University of Miami, Sylvester Cancer Research Center
Miami, Florida, 33139
Clinical Trials and Research Associates
Montebello, California, 90640
Beth Israel Cancer Center
New York, New York, 10003
Comprehensive Cancer Centers of the Desert
Palm Springs, California, 92262
Cancer Research Network Inc
Plantation, Florida, 33324
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
Northwest Medical Specialists, PLLC
Tacoma, Washington, 98405
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33162
Arizona Clinical Research Center
Tucson, Arizona, 85712
About this study
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
To evaluate the efficacy of dexmethylphenidate (d-MPH) in the treatment of chemotherapy-related fatigue in adult cancer subjects.
- Being tested
- dexmethylphenidate(d-mph)
- Keywords
- neurobehavioral function, chemobrain, chemo brain, fatigue, memory loss, exhausted, trouble concentrating
- Medical subject headings
- Fatigue, Neoplasms, Chemotherapy-Related Cognitive Impairment, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmethylphenidate(d-mph)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2002 (estimated)
- Study startJun 2002
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Celgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047476
- Sponsor's protocol ID
- d-MPH-COG-002
- Status last verified
- May 2004
- First submitted
- 8 Oct 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00047476
- Acronym / sponsor ID
- d-MPH-COG-002
- Keywords
- neurobehavioral function, chemobrain, chemo brain, fatigue, memory loss, exhausted, trouble concentrating
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- Celgene CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Study completion
- Mar 2004
- First posted
- 9 Oct 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of dexmethylphenidate (d-MPH) in the treatment of chemotherapy-related fatigue in adult cancer subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmethylphenidate(d-mph) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dexmethylphenidate(d-mph) in people with Fatigue and Neoplasms, run by Celgene Corporation at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.