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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT05041946
Collaborator
(none)
112
1
2
220.2
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Patient Controlled Methylphenidate for Cancer Related Fatigue: A Double Blind, Randomized, Placebo Controlled Trial
Actual Study Start Date :
Jul 16, 2003
Actual Primary Completion Date :
Nov 19, 2021
Actual Study Completion Date :
Nov 19, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Methylphenidate

treatment of attention deficit disorder and narcolepsy (sleep disorder)

Drug: Methylphenidate
Given PO

Other: Placebo (Sugar Pill)
Given PO

Experimental: Placebo

Sugar pill

Drug: Methylphenidate
Given PO

Other: Placebo (Sugar Pill)
Given PO

Outcome Measures

Primary Outcome Measures

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 M D Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Eduardo Bruera, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT05041946
Other Study ID Numbers:
  • 2003-0537
  • NCI-2021-10777
First Posted:
Sep 13, 2021
Last Update Posted:
Dec 17, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 17, 2021