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

NCT ID: NCT05041946

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-16
• Study Completion Date: 2021-11-19

Brief Summary

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.

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

Conditions

Fatigue; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Methylphenidate

treatment of attention deficit disorder and narcolepsy (sleep disorder)

Group Type: EXPERIMENTAL

Methylphenidate

Intervention Type: DRUG

Given PO

Placebo (Sugar Pill)

Intervention Type: OTHER

Given PO

Placebo

Sugar pill

Group Type: EXPERIMENTAL

Methylphenidate

Intervention Type: DRUG

Given PO

Placebo (Sugar Pill)

Intervention Type: OTHER

Given PO

Interventions

Methylphenidate

Given PO

Intervention Type: DRUG

Placebo (Sugar Pill)

Given PO

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduardo Bruera

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

2003-0537

Identifier Type: -

Identifier Source: org_study_id

NCI-2021-10777

Identifier Type: OTHER

Identifier Source: secondary_id