Methylphenidate and a Nursing Telephone Intervention for Fatigue

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by M.D. Anderson Cancer Center.
Recruitment status was  Active, not recruiting
Sponsor:
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
  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:

  1. Patients will be eligible to participate in this study if they have advanced cancer.
  2. 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
  3. Describe fatigue as being present every day for most of day for a minimum of 2 weeks
  4. Lack clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered normal
  5. Are 18 years or older
  6. 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
  7. 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
  8. 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
  9. Able to understand the description of the study and give written informed consent.
  10. Able to understand the description of assessments, and able to complete baseline assessment
  11. Patients on no erythropoietin or stable dose.

Exclusion Criteria:

  1. Major contraindication to methylphenidate i.e. hypersensitivity, anxiety, tension, agitation, or motor tics, glaucoma, severe angina pectoris, or hypertension, etc.
  2. Currently on methylphenidate or has been on methylphenidate within the last 10 days.
  3. Inability to complete the baseline assessment forms or do understand the recommendations for participation in the study
  4. Major depression according to the SCID DSM IV diagnostic criteria. These patients wil be referred immediately to psychiatry for assessment and management
  5. Pregnant or lactating women
  6. Requirement for MAO inhibitors, tricyclic antidepressants or clonidine
  7. Glaucoma, history of marked anxiety disorders
  8. 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.
  9. Tourette's syndrome
  10. Symptomatic tachycardia and uncontrolled hypertension.
  11. Currently receiving oral anticoagulants (Coumadin/warfarin), anticonvulsants (Phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine).
  12. Patients with pacemakers
  13. Patients with symptomatic cardiac arrhythmias
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014