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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05041946
Other study ID # 2003-0537
Secondary ID NCI-2021-10777
Status Completed
Phase Phase 3
First received
Last updated
Start date July 16, 2003
Est. completion date November 19, 2021

Study information

Verified date September 2022
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date November 19, 2021
Est. primary completion date December 15, 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Methylphenidate
Given PO
Other:
Placebo (Sugar Pill)
Given PO

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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