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

NCT02361125 | Completed Phase 1 FDA Drug

• 2 other identifiers: ID02-166NCI-2015-00623
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fatigue

Keywords

Fatigue; Cancer related fatigue; Methylphenidate; Methylphenidate Hydrochloride; Ritalin; Concerta; Fatigue evaluations

Outcome Measures

Primary Outcomes (1)

• Fatigue Measurement on a 10-point scale

  Primary endpoint is fatigue as measured on a 10-point scale. An average 2-point reduction in fatigue from before to 2 hours after taking methylphenidate considered a clinical success.

  7 days

Study Arms (1)

Methylphenidate

EXPERIMENTAL

Participants given a 7 day supply of 5 mg methylphenidate tablets (to take a maximum of 20 mg/day, for total of 28 tablets). Directions for use are to take one 5 mg tablet by mouth as needed every 2 hours for participant described significant fatigue (maximum of 4 tablets/day). Evaluation of fatigue, ability to sleep, and general symptom questions at baseline visit, daily while on study drug, and on seventh day of treatment.

Drug: Methylphenidate; Behavioral: Fatigue Evaluations

Interventions

Methylphenidate DRUG

5 mg tablet by mouth as needed every 2 hours for participant described significant fatigue. Participants to take a maximum of 20 mg/day, for total of 28 tablets for 7 days.

Also known as: Methylphenidate Hydrochloride, Ritalin, Concerta

Methylphenidate

Fatigue Evaluations BEHAVIORAL

Participants to have evaluation of their fatigue, ability to sleep, and will answer a set of general symptom questions at baseline visit, daily while on study drug, and on seventh day of treatment.

Methylphenidate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients seen in the outpatient palliative care clinic or inpatients seen by the palliative care consult team or the fatigue clinic.
• 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.
• Patient should describe fatigue as being present for a minimum of four days.
• 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.
• 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.
• Signed written informed consent.
• Patient must be 18 years or older.The questionnaires used in this study have been validated only in the adult population.
• 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.
• 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.

You may not qualify if:

• Major contraindication to methylphenidate i.e. hypersensitivity
• 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.
• Pregnant or lactating women. Childbearing age women are not on birth control.
• Patients taking MAO inhibitors, tricyclic antidepressants, clonidine, psychostimulants, concurrent steroids or other medications specifically for fatigue
• Patients with glaucoma, history of marked anxiety disorder, or history of substance abuse.
• CAGE questionnaire score is 2 or above on a 0 to 4 scale.
• Patients with history of seizures or uncontrolled CNS disease, significant hepatic or renal dysfunction.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Fatigue

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eduardo Bruera, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 11, 2015
• Study Start: August 1, 2002
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: January 4, 2022

Record last verified: 2022-01

Locations

US (1)