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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00424099 |
Purpose
The goal of this clinical research study is to learn if methylphenidate (Ritalin) can help to control fatigue caused by cancer. Its effect on other symptoms such as drowsiness, depression, sleeplessness, physical activity, and anxiety will also be studied. Another goal of this study is to learn if receiving a phone call by a nurse improves fatigue in patients.
| Condition | Intervention |
|---|---|
|
Advanced Cancer Fatigue |
Drug: Methylphenidate Behavioral: Nursing Telephone Intervention Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | A Randomized Controlled Trial of Methylphenidate and a Nursing Telephone Intervention (NTI) for Fatigue in Advanced Cancer Patients |
| Estimated Enrollment: | 212 |
| Study Start Date: | January 2007 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Methylphenidate + Nursing Telephone Intervention
|
Drug: Methylphenidate
5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days.
Other Name: Ritalin
Behavioral: Nursing Telephone Intervention
Call from study nurse 3 times weekly to ask about side effects and other symptoms.
Other Name: NTI
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Placebo Comparator: Group 2
Placebo + Nursing Telephone Intervention
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Behavioral: Nursing Telephone Intervention
Call from study nurse 3 times weekly to ask about side effects and other symptoms.
Other Name: NTI
Drug: Placebo
One capsule, orally every two hours as needed up to a maximum of 4 capsules per day for a period of 14 days.
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Experimental: Group 3
Methylphenidate
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Drug: Methylphenidate
5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days.
Other Name: Ritalin
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Experimental: Group 4
Placebo
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Drug: Placebo
One capsule, orally every two hours as needed up to a maximum of 4 capsules per day for a period of 14 days.
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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 | |
| Lyndon Baines Johnson (LBJ) Hospital | |
| Houston, Texas, United States, 77026 | |
| Principal Investigator: | Eduardo Bruera, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00424099 History of Changes |
| Other Study ID Numbers: | 2005-0613 |
| Study First Received: | January 16, 2007 |
| Last Updated: | December 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Advanced Cancer Fatigue Nursing Telephone Intervention NTI |
Methylphenidate Placebo Ritalin |
|
Fatigue Neoplasms 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 |