Methylphenidate and a Nursing Telephone Intervention for Fatigue
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00424099
First received: January 16, 2007
Last updated: December 6, 2011
Last verified: December 2011
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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 |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Difference between Patient FACIT-F Fatigue Sub Score Baseline and 15 Days Later [ Time Frame: 15 days after Baseline ] [ Designated as safety issue: No ]
| 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
|
|
Placebo Comparator: Group 2
Placebo + Nursing Telephone Intervention
|
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.
|
|
Experimental: Group 3
Methylphenidate
|
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
|
|
Experimental: Group 4
Placebo
|
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.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients will be eligible to participate in this study if they have advanced cancer.
- Patients will be eligible to participate in this study if they rate fatigue on the ESAS during the last 24 hours as greater than or equal to 4 on a 0-10 scale, in which 0= no fatigue and 10=worst possible fatigue
- Describe fatigue as being present every day for most of day for a minimum of 2 weeks
- Lack clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered normal
- Are 18 years or older
- Are willing to keep a daily diary, engage in telephone follow up with a nurse every other day, and return for follow-up visit after 14 days of treatment
- Have telephone access to be contacted by the research nurse. If patient is relocating within 5 weeks, patient will be asked to provide a new telephone number
- Hemoglobin of greater than or equal to 8 g/dl within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the past 2 weeks, one will be done to determine the eligibility. Patients with a hemoglobin of less than 8 will be referred for treatment of their anemia
- Able to understand the description of the study and give written informed consent.
- Able to understand the description of assessments, and able to complete baseline assessment
- Patients on no erythropoietin or stable dose.
Exclusion Criteria:
- Major contraindication to methylphenidate i.e. hypersensitivity, anxiety, tension, agitation, or motor tics, glaucoma, severe angina pectoris, or hypertension, etc.
- Currently on methylphenidate or has been on methylphenidate within the last 10 days.
- Inability to complete the baseline assessment forms or do understand the recommendations for participation in the study
- Major depression according to the SCID DSM IV diagnostic criteria. These patients wil be referred immediately to psychiatry for assessment and management
- Pregnant or lactating women
- Requirement for MAO inhibitors, tricyclic antidepressants or clonidine
- Glaucoma, history of marked anxiety disorders
- History of alcohol (CAGE questionnaire score for the last 2 years is 2 or above on a 0 to 4 scale) or substance abuse including illegal drugs and/or medications.
- Tourette's syndrome
- Symptomatic tachycardia and uncontrolled hypertension.
- Currently receiving oral anticoagulants (Coumadin/warfarin), anticonvulsants (Phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine).
- Patients with pacemakers
- Patients with symptomatic cardiac arrhythmias
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424099
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Lyndon Baines Johnson (LBJ) Hospital | |
| Houston, Texas, United States, 77026 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Eduardo Bruera, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| 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 |
Keywords provided by M.D. Anderson Cancer Center:
|
Advanced Cancer Fatigue Nursing Telephone Intervention NTI |
Methylphenidate Placebo Ritalin |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 19, 2013