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

Phase 3

Completed

• Conditions: Fatigue; Cancer
• Interventions: Drug: Methylphenidate; Other: Placebo (Sugar Pill)

• Registration Number: NCT05041946
• Lead Sponsor: M.D. Anderson Cancer Center

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

Study Timeline

• Study Start: 2003-07-16
• Primary Completion: 2004-12-15
• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-13
• Study Completion: 2021-11-19
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Methylphenidate	Placebo (Sugar Pill)	treatment of attention deficit disorder and narcolepsy (sleep disorder)
Placebo	Placebo (Sugar Pill)	Sugar pill
Placebo	Methylphenidate	Sugar pill
Methylphenidate	Methylphenidate	treatment of attention deficit disorder and narcolepsy (sleep disorder)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States