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Effect of Methylphenidate on Cancer-related Cognitive Impairment

NCT02970500 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-03-23

No results posted yet for this study

Summary

Cancer-related cognitive Impairment (CRCI), commonly referred to as "chemo brain" or "brain fog"-impact severely on the Quality of Life (QoL) of cancer survivors. However, it still remains underdiagnosed and challenging to treat. One of the treatment options is the use of psychostimulants such as Methylphenidate (MP), but well-designed clinical trials to test its efficacy are limited. We will conduct a phase II study with a mixed method design to explore the preliminary efficacy of MP to improve cognitive function and QoL in breast cancer patients after treatment with chemotherapy and/or radiotherapy and determine the parameters needed for designing a phase III study.

Conditions

  • Breast Cancer Female
  • Cancer-Related Condition

Interventions

DRUG

Methylphenidate HCl 10Mg SR

Methylphenidate HCl 10Mg SR (Phase 1) and Methylphenidate HCl 20Mg SR (Phase 2)

DRUG

Placebo Group

Placebo

Sponsors & Collaborators

  • Équipe de Recherche Michel-Sarrazin en Oncologie psychosociale et Soins palliatifs

    collaborator UNKNOWN

  • Purdue Pharma LP

    collaborator INDUSTRY

  • Fondation de l'Hôtel-Dieu de Lévis

    collaborator UNKNOWN

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Bruno Gagnon · Laval University, Centre de recherche du CHU de Québec

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-09
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02970500 on ClinicalTrials.gov