Breast Cancer FemalePhase 2CogMetNCT02970500
Effect of Methylphenidate on Cancer-related Cognitive Impairment
A Phase 2 study testing Methylphenidate HCl 10Mg SR in people with Breast Cancer Female and Cancer-Related Condition, run by CHU de Quebec-Universite Laval at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer Female, Cancer-Related Condition
- What is being tested?
- Methylphenidate HCl 10Mg SR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- 9 Oct 2017to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current or recent use (<2 years) of psychostimulant drugs
- Women receiving drugs with a potential of interaction with methylphenidate:
- 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:
- 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. Generalized anxiety disorder or panic attacks 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hôpital Hôtel-Dieu de Lévis
Lévis, Quebec, G6V 3Z1
Centre de recherche du CHU de QUébec
Québec, G1R 2J6
About this study
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
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.
Read the 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:
- 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;
- complaining about cognitive impairment;
- 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.
- Conditions
- Breast Cancer Female, Cancer-Related Condition
- Being tested
- Methylphenidate HCl 10Mg SR, Placebo Group
- Keywords
- Cognitive impairment, Methylphenidate, Cancer-related cognitive impairment, Mixed method, Phase II study, Breast cancer
- Medical subject headings
- Cognitive Dysfunction, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylphenidate HCl 10Mg SRDrug
Methylphenidate HCl 10Mg SR (Phase 1) and Methylphenidate HCl 20Mg SR (Phase 2)
Placebo GroupDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive impairment level
'Perceived Cognitive Impairments' (PCI) subscale of the Functional Assessment of Cancer Therapy-Cognitive Function questionnaire (FACT-Cog) test
Measured: Up to 24 months
Secondary outcomes (3)
Methylphenidate side effects
Tracking and registration of methylphenidate side effects
Measured: Up to 24 months
Methylphenidate effect on fatigue
Fatigue evaluation with a validated questionnaire: Multidimensional Fatigue Inventory (MFI)
Measured: Up to 24 months
Experience of women with cancer-related cognitive impairment in cancer
Semi-structured interviews
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start9 Oct 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: We decided to close recruitment in December 2022 as we were having trouble recruiting participants who met our inclusion criteria and the study funding was coming to an end.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Équipe de Recherche Michel-Sarrazin en Oncologie psychosociale et Soins palliatifs, Purdue Pharma LP, Fondation de l'Hôtel-Dieu de Lévis
- Responsible party
- Principal investigator, Dr Bruno Gagnon, CHU de Quebec-Universite Laval
- Investigators
- Bruno Gagnon, Principal investigator, Laval University, Centre de recherche du CHU de Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970500
- Sponsor's protocol ID
- 2016-MPH-02-3006
- Acronym
- CogMet
- Status last verified
- Mar 2023
- First submitted
- 18 Nov 2016
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02970500
- Acronym / sponsor ID
- CogMet / 2016-MPH-02-3006
- Conditions
- Breast Cancer Female, Cancer-Related Condition
- Keywords
- Cognitive impairment, Methylphenidate, Cancer-related cognitive impairment, Mixed method, Phase II study, Breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We decided to close recruitment in December 2022 as we were having trouble recruiting participants who met our inclusion criteria and the study funding was coming to an end.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Équipe de Recherche Michel-Sarrazin en Oncologie psychosociale et Soins palliatifs, Purdue Pharma LP, Fondation de l'Hôtel-Dieu de Lévis
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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;
- complaining about cognitive impairment;
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate HCl 10Mg SR | Experimental | Drug: Methylphenidate HCl 10Mg SRParticipants 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. |
| Placebo Group | Placebo comparator | Drug: Placebo GroupParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Current or recent use (<2 years) of psychostimulant drugs
- Women receiving drugs with a potential of interaction with methylphenidate:
- Conditions that may increase the risk of cognitive impairment or toxicity of methylphenidate such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylphenidate HCl 10Mg SRMethylphenidate HCl 10Mg SR (Phase 1) and Methylphenidate HCl 20Mg SR (Phase 2) | Drug | Methylphenidate HCl 10Mg SR |
| Placebo GroupPlacebo | Drug | Placebo Group |
Primary outcome
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
3 secondary outcomes
Methylphenidate side effects
Time frame: Up to 24 months
Methylphenidate effect on fatigue
Time frame: Up to 24 months
Experience of women with cancer-related cognitive impairment in cancer
Time frame: Up to 24 months
Results and safety
The study was stopped early (reason given: We decided to close recruitment in December 2022 as we were having trouble recruiting participants who met our inclusion criteria and the study funding was coming to an end.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Gagnon principal investigator
Laval University, Centre de recherche du CHU de Québec
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylphenidate HCl 10Mg SR in people with Breast Cancer Female and Cancer-Related Condition, run by CHU de Quebec-Universite Laval at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: We decided to close recruitment in December 2022 as we were having trouble recruiting participants who met our inclusion criteria and the study funding was coming to an end.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive impairment level (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.