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Effect of Methylphenidate on Cancer-related Cognitive Impairment (CogMet)

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ClinicalTrials.gov Identifier: NCT02970500
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
Équipe de Recherche Michel-Sarrazin en Oncologie psychosociale et Soins palliatifs
Purdue Pharma LP
Information provided by (Responsible Party):
Dr Bruno Gagnon, CHU de Quebec-Universite Laval

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Cancer-Related Condition Drug: Methylphenidate HCl 10Mg SR Drug: Placebo Group Phase 2

Detailed Description:

Objectives: The main objective of this study is to determine the parameters for a phase III study to measure the efficacy of MP in improving CRCI in women with breast cancer who received chemotherapy and/or radiotherapy. In addition, the profile of drug side effects will be estimated. A better understanding of CRCI and its impact on the activities and QoL of the study population is targeted.

Population: The sample will consist of 40 women in remission of non-metastatic breast cancer whose profile meets the following criteria:

  1. receiving follow-up at the radio-oncology department of the CHU de Québec-Université Laval or at any other health institutions in Quebec participating in the project;
  2. complaining about cognitive impairment;
  3. not having any contraindications to the taking of MP or any medical condition that may interfere with his taking and/or any medical condition that could explain the cognitive impairment.

Before study inclusion, the eligibility of these women will be validated by questionnaires and medical records.

Study design: This study will follow the design of a randomized, double-blind, placebo-controlled trial that includes a mixed methodology (convergent design).

Procedures: The study will be divided into two phases. The first phase will start at time T0, before any MP is taken, and will last 14 days (T1). Participants will be assigned to the intervention group, where they will receive 10 mg of MP controlled-release (SR) for 14 days, or the control group where they will receive an identical placebo capsule for 14 days. The second phase begins at T1 and ends 14 days later (T2). This phase will explore a higher dosage. Participants from the intervention group during phase 1 will received an increased dose of MP (20 mg - two capsules) during 14 days whereas participants from the control group will receive two placebo capsules during 14 days.

Measures: Quantitative data. Questionnaires and tests will be used. The effect size calculation will be based on the 'Perceived Cognitive Impairments' (PCI) subscale of the Functional Assessment of Cancer Therapy-Cognitive Function questionnaire (FACT-Cog) test and will be used to determine the required power for a phase III study. Other tests will be explored to assess the sensitivity to measure cognitive changes. Descriptive statistical analysis will be performed. Tests such as the T-Test, χ2 and ANOVA will be used to estimate the degree of improvement of cognitive function by comparing data of the different groups. Qualitative data. Interviews will be conducted with the 40 women included in the study. These interviews will focus on their experience of cognitive deficits before and after taking MP/Placebo at T0 and T2. In order to document the experience of these women and to assess the transferability of the resutls, two methods will be combined to analyze these interviews: an intra-case analysis and an inter-case analysis. Each of the components of the study will answer its main questions independently. However, the data will also be matched (triangulation) to provide a global understanding of the issue and convergence of results when possible.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Étude Pilote de Phase II Sur l'Effet du méthylphénidate Sur la Fonction Cognitive Des Patientes en rémission d'un Cancer du Sein
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methylphenidate HCl 10Mg SR
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
Methylphenidate HCl 10Mg SR (Phase 1) and Methylphenidate HCl 20Mg SR (Phase 2)

Placebo Comparator: Placebo Group
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
Placebo




Primary Outcome Measures :
  1. Change in cognitive impairment level [ Time Frame: Up to 24 months ]
    'Perceived Cognitive Impairments' (PCI) subscale of the Functional Assessment of Cancer Therapy-Cognitive Function questionnaire (FACT-Cog) test


Secondary Outcome Measures :
  1. Methylphenidate side effects [ Time Frame: Up to 24 months ]
    Tracking and registration of methylphenidate side effects

  2. Methylphenidate effect on fatigue [ Time Frame: Up to 24 months ]
    Fatigue evaluation with a validated questionnaire: Multidimensional Fatigue Inventory (MFI)

  3. Experience of women with cancer-related cognitive impairment in cancer [ Time Frame: Up to 24 months ]
    Semi-structured interviews



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Current or recent use (<2 years) of psychostimulant drugs
  2. Women receiving drugs with a potential of interaction with methylphenidate:

    i. Anticoagulants ii. Antidepressants with the exception of: amitriptyline at a dose ≤75mg daily, desipramine at a dose ≤75mg daily, nortriptyline at a dose ≤50mg daily, drugs and dosages used to control symptoms other than depression. 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.

  3. Conditions that may increase the risk of cognitive impairment or toxicity of methylphenidate such as:

    i. Pregnancy and breastfeeding ii. Bipolar status iii. Cerebral tumor or any brain injury iv. Metastatic cancer v. Alcohol addiction vi. Active Major depression vii. Parkinson disease viii. Dementia ix. Epilepsia x. Glaucoma xi. Cardiovascular diseases xii. Auto-immunes and chronic inflammatory disease xiii. Cerebrovascular disease xiv. Narcolepsy xv. Pheochromocytoma xvi. Thyrotoxicosis xvii. Motor tic, Tourette syndrome xviii. Anxiety xix. Living under the same roof as people taking Biphentin® 10 mg capsules (this exclusion criteria is necessary because the placebo capsule is identical to the commercial formulation of Biphentin®) xx. Any other medical criteria, according to the clinical judgment of the principal investigator.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970500


Contacts
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Contact: Mauranne Labonté 418-525-4444 ext 21662 mauranne.labonte@crchudequebec.ulaval.ca
Contact: Bruno Gagnon 418-525-4444 ext 21706 Gagnon.Bruno@crchudequebec.ulaval.ca

Locations
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Canada, Quebec
Groupe de médecine de famille universitaire de Saint-Charles-Borromée Not yet recruiting
Saint-Charles-Borromée, Quebec, Canada, J6E 0W6
Contact: Mauranne Labonté, MSc    418-525-4444 ext 21662    mauranne.labonte@crchudequebec.ulaval.ca   
Sub-Investigator: Bruno Gagnon, MD, MSc         
Principal Investigator: Jean-Sébastien Paquette, MD, MSc         
Canada
Centre de recherche du CHU de QUébec Recruiting
Quebec, Canada, G1R 2J6
Contact: Mauranne Labonté, MSc    418-525-4444 ext 21662    mauranne.labonte@crchudequebec.ulaval.ca   
Principal Investigator: Bruno Gagnon, MD, MSc.         
Sub-Investigator: Anne Dagnault, MD, PhD         
Sub-Investigator: Pierre Gagnon, MD, PhD         
Sub-Investigator: Maman J Dogba, MD, PhD         
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Équipe de Recherche Michel-Sarrazin en Oncologie psychosociale et Soins palliatifs
Purdue Pharma LP
Investigators
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Principal Investigator: Bruno Gagnon Laval University, Centre de recherche du CHU de Québec

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Responsible Party: Dr Bruno Gagnon, Associate Professor, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02970500     History of Changes
Other Study ID Numbers: 2016-MPH-02-3006
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Bruno Gagnon, CHU de Quebec-Universite Laval:
Cognitive impairment
Methylphenidate
Cancer-related cognitive impairment
Mixed method
Phase II study
Breast cancer

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents