NCT02970500

Brief 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

October 9, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

5.2 years

First QC Date

November 18, 2016

Last Update Submit

March 21, 2023

Conditions

Breast Cancer FemaleCancer-Related Condition

Keywords

Cognitive impairmentMethylphenidateCancer-related cognitive impairmentMixed methodPhase II studyBreast cancer

Outcome Measures

Primary Outcomes (1)

  • Change in cognitive impairment level

    'Perceived Cognitive Impairments' (PCI) subscale of the Functional Assessment of Cancer Therapy-Cognitive Function questionnaire (FACT-Cog) test

    Up to 24 months

Secondary Outcomes (3)

  • Methylphenidate side effects

    Up to 24 months

  • Methylphenidate effect on fatigue

    Up to 24 months

  • Experience of women with cancer-related cognitive impairment in cancer

    Up to 24 months

Study Arms (2)

Methylphenidate HCl 10Mg SR

EXPERIMENTAL

Participants of the intervention group (n=20) will receive 1 capsule of Methylphenidate HCl 10 mg SR each morning during 14 days during phase 1 and 2 capsules of Methylphenidate HCl 10 mg SR each morning during 14 days during phase 2.

Drug: Methylphenidate HCl 10Mg SR

Placebo Group

PLACEBO COMPARATOR

Participants of the control group (n=20) will receive 1 capsule of placebo each morning during 14 days during phase 1 and 2 capsules of placebo each morning during 14 days during phase 2.

Drug: Placebo Group

Interventions

Methylphenidate HCl 10Mg SRDRUG

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

Methylphenidate HCl 10Mg SR
Placebo GroupDRUG

Placebo

Placebo Group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast cancer stage I, II or III
  • Completed chemotherapy and/or radiotherapy at least 6 months before entering the study
  • Being in remission of breast cancer
  • Complaining of cognitive impairment

You may not qualify if:

  • Current or recent use (\<2 years) of psychostimulant drugs
  • Women receiving drugs with a potential of interaction with methylphenidate:
  • i. Anticoagulants; ii. Antidepressants with the exception of: amitriptyline (≤75mg); citalopram (≤40mg); desipramine (≤75mg); duloxetine (≤60mg); escitalopram (≤20mg); fluoxetine (≤60mg); fluvoxamine (≤150mg); mirtazapine (≤60mg); nortriptyline (≤50mg); trazadone (≤50mg); venlafaxine (≤150mg); vortioxetine (≤20mg); iii. Drugs (cocaine); iv. Erythropoietin; v. Drugs acting on the cerebral dopaminergic system, including drugs that inhibit monoamine oxidase; vi. John's wort, natural medicines for depression or supplements for fatigue.
  • Conditions that may increase the risk of cognitive impairment or toxicity of methylphenidate such as:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Hôtel-Dieu de Lévis

Lévis, Quebec, G6V 3Z1, Canada

Location

Centre de recherche du CHU de QUébec

Québec, G1R 2J6, Canada

Location

MeSH Terms

Conditions

Cognitive DysfunctionBreast Neoplasms

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bruno Gagnon

    Laval University, Centre de recherche du CHU de Québec

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 18, 2016

First Posted

November 22, 2016

Study Start

October 9, 2017

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)