Patient Controlled Methylphenidate for Cancer Related Fatigue: A Double Blind, Randomized, Placebo Controlled Trial
Study Details
Study Description
Brief Summary
To determine the effectiveness of patient controlled methylphenidate as compared to placebo for the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
Primary objective:
-To determine the effectiveness of patient controlled methylphenidate as compared to placebo for the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score
Secondary objective
-
To assess the efficacy of as needed methylphenidate on pain, sedation and quality of life.
-
To assess the potential side effects of methylphenidate on appetite, insomnia and anxiety
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Methylphenidate treatment of attention deficit disorder and narcolepsy (sleep disorder) |
Drug: Methylphenidate
Given PO
Other: Placebo (Sugar Pill)
Given PO
|
Experimental: Placebo Sugar pill |
Drug: Methylphenidate
Given PO
Other: Placebo (Sugar Pill)
Given PO
|
Outcome Measures
Primary Outcome Measures
- To establish the effectiveness of patient the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score: 0-10 numerical scale. [through study completion, an average of 1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Presence of fatigue on a numerical scale during the last 24 hours of more or equal to 4 on a 0 to 10 scale in which 0 equals no fatigue and 10 worst possible fatigue.
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Patients should describe fatigue as being present for a minimum of four days.
-
If patients are on opioids for the treatment of cancer pain, change of opioids is allowed.
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No clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered as normal.
-
Sign written informed consent.
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Patients must be 18 years or older.
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Patient willing to keep a daily diary, engage in daily telephone follow up with a nurse, and after 7 days of treatment patient will return for a follow up visit.
-
Patient must have telephone access to be contacted daily by the research nurse.
-
Hemoglobin of >/=10 g/dl within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the past two weeks, one will be done to determine the eligibility.
Exclusion Criteria:
-
Major contraindication to methylphenidate i.e. hypersensitivity, anxiety, tension, agitation, or motor tics
-
Currently on methylphenidate or has been on methylphenidate within the last 10 days.
-
Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study.
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Pregnant or lactating women.
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Patients taking MAO inhibitors, tricyclic antidepressants and clonidine.
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Patients with glaucoma, history of marked anxiety disorder, or history of substance abuse.
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CAGE questionnaire score for the last 2 years is 2 or above on a 0 to 4 scale
-
History of Tourette's syndrome
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Patients with tachycardia and uncontrolled hypertension.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Eduardo Bruera, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2003-0537
- NCI-2021-10777