Patient Controlled Methylphenidate for Cancer Related Fatigue: A Double Blind, Randomized, Placebo Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Fatigue
• Intervention / Treatment: Drug: Methylphenidate; Other: Placebo (Sugar Pill)

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• 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.
• 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.
• Patients must be 18 years or older.
• 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.
• Pregnant or lactating women.
• Patients taking MAO inhibitors, tricyclic antidepressants and clonidine.
• Patients with glaucoma, history of marked anxiety disorder, or history of substance abuse.
• CAGE questionnaire score for the last 2 years is 2 or above on a 0 to 4 scale
• History of Tourette's syndrome
• Patients with tachycardia and uncontrolled hypertension.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Eduardo Bruera, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2003
• Primary Completion (Actual): December 15, 2004
• Study Completion (Actual): November 19, 2021

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: 2003-0537; NCI-2021-10777 (Other Identifier: NCI ID)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No