Methylphenidate and a Nursing Telephone Intervention for Fatigue

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Institute of Nursing Research (NINR)
• Treatments: Methylphenidate

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 Edmonton Symptom Assessment System (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 Structured Clinical Interview (SCID) Diagnostic and Statistical Manual of Mental Disorders (DSM) IV diagnostic criteria. These patients wil be referred immediately to psychiatry for assessment and management

5. Pregnant or lactating women

6. Requirement for Monoamine oxidase inhibitors (MAOIs), 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