Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors

Phase 3

Terminated

• Conditions: Fatigue; Brain and Central Nervous System Tumors; Cognitive/Functional Effects; Depression; Quality of Life

• Registration Number: NCT00031798
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

RATIONALE: Methylphenidate may decrease side effects of radiation therapy. It is not yet known if methylphenidate is effective in improving quality of life in patients with primary or metastatic brain tumors.

PURPOSE: Randomized phase III trial to determine the effectiveness of methylphenidate in improving quality of life in patients who have brain tumors and are undergoing radiation therapy.

Detailed Description

OBJECTIVES:

* Determine the effect of d-methylphenidate on fatigue in patients receiving radiotherapy for primary or metastatic brain tumors.

* Determine the effect of this drug on the quality of life of these patients.

* Determine the effect of this drug on depression in these patients.

* Determine the effect of this drug on global neurocognitive function, including attention and concentration, memory, language, visuospatial skills, and executive function, in these patients.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified by tumor type (primary vs metastatic), treatment (radiotherapy vs radiotherapy and chemotherapy), and Karnofsky performance status (70% or 80% vs 90% or 100%). Patients are randomized to one of two treatment arms.

All patients undergo radiotherapy over weeks 1-4.

* Arm I: Patients receive oral d-methylphenidate twice daily on weeks 1-12.

* Arm II: Patients receive oral placebo twice daily on weeks 1-12. In both arms, quality of life is assessed at baseline, at the end of radiotherapy, and at 4, 8, and 12 weeks after radiotherapy.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study within 18 months.

Study Timeline

• Study First Submitted: 2002-03-08
• Study Start: 2002-04-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-03-01
• Study Completion: 2006-05-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (7)

CCOP - Western Regional, Arizona; 🇺🇸 Phoenix, Arizona, United States

CCOP - Upstate Carolina; 🇺🇸 Spartanburg, South Carolina, United States

CCOP - Central Illinois; 🇺🇸 Decatur, Illinois, United States

CCOP - Columbus; 🇺🇸 Columbus, Ohio, United States

CCOP - Southeast Cancer Control Consortium; 🇺🇸 Goldsboro, North Carolina, United States

MBCCOP - LSU Health Sciences Center; 🇺🇸 New Orleans, Louisiana, United States

Comprehensive Cancer Center at Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States