Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue - PRN Methylphenidate

• Status: Active, not recruiting
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to evaluate the effectiveness of ritalin (methylphenidate) taken on an as needed basis for the management of cancer related fatigue. The effects of methylphenidate on pain, mood, and sedation will be evaluated. Researchers will also evaluate the level of fatigue throughout the day and any possible causes of fatigue.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

1. Patients seen in the outpatient palliative care clinic or inpatients seen by the palliative care consult team or the fatigue clinic.

2. Presence of fatigue on a numerical scale during the last 24 hours of more or equal to 4 on a 0 to 10 scale on which 0 equals no fatigue and 10 worst possible fatigue.

3. Patient should describe fatigue as being present for a minimum of four days.

4. If patients are on opioids for the treatment of cancer pain, they must have had no dose changes (>25%) for at least 48 hours prior to study entry. Change in opioid dose after study entry is allowed.

5. Presence of relatively intact cognition defined by normal Mini Mental State Questionnaire according to age and education level. A score of 24 or above is usually considered normal.

6. Signed written informed consent.

7. Patient must be 18 years or older.The questionnaires used in this study have been validated only in the adult population.

8. Patient willing to keep a daily fatigue diary, engage in daily telephone follow up with a nurse and after 7 days of treatment either return for a follow up visit or this can be done over the telephone.

9. 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:

1. Major contraindication to methylphenidate i.e. hypersensitivity

2. Currently on methylphenidate or has been on methylphenidate within the last 10 days.

3. Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study.

4. Pregnant or lactating women. Childbearing age women are not on birth control.

5. Patients taking MAO inhibitors, tricyclic antidepressants, clonidine, psychostimulants, concurrent steroids or other medications specifically for fatigue

6. Patients with glaucoma, history of marked anxiety disorder, or history of substance abuse.

7. CAGE questionnaire score is 2 or above on a 0 to 4 scale.

8. Patients with history of seizures or uncontrolled CNS disease, significant hepatic or renal dysfunction.