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

NCT05041946 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: 2003-0537NCI-2021-10777
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Methylphenidate

EXPERIMENTAL

treatment of attention deficit disorder and narcolepsy (sleep disorder)

Drug: Methylphenidate; Other: Placebo (Sugar Pill)

Placebo

EXPERIMENTAL

Sugar pill

Drug: Methylphenidate; Other: Placebo (Sugar Pill)

Interventions

Methylphenidate DRUG

Given PO

Methylphenidate; Placebo

Placebo (Sugar Pill) OTHER

Given PO

Methylphenidate; Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Fatigue; Neoplasms

Interventions

Methylphenidate; Sugars

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; Carbohydrates

Study Officials

• Eduardo Bruera

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: July 16, 2003
• Primary Completion: December 15, 2004
• Study Completion: November 19, 2021
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

US (1)