Clinical trial NCT05041946: Patient Controlled Methylphenidate for Cancer Related Fatigue: A Double Blind, Randomized, Placebo Controlled Trial
Official title: Patient Controlled Methylphenidate for Cancer Related Fatigue: A Double Blind, Randomized, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fatigue
Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: 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.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Eduardo Bruera
role: PRINCIPAL_INVESTIGATOR
References: