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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 April 2023 |
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Main ID: |
NCT02970500 |
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Date of registration:
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18/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Methylphenidate on Cancer-related Cognitive Impairment
CogMet |
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Scientific title:
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Étude Pilote de Phase II Sur l'Effet du méthylphénidate Sur la Fonction Cognitive Des Patientes en rémission d'un Cancer du Sein |
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Date of first enrolment:
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October 9, 2017 |
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Target sample size:
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20 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02970500 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Bruno Gagnon |
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Address:
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Telephone:
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Email:
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Affiliation:
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Laval University, Centre de recherche du CHU de Québec |
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Key inclusion & exclusion criteria
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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 (=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.
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. 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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer Female
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Cancer-Related Condition
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Intervention(s)
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Drug: Placebo Group
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Drug: Methylphenidate HCl 10Mg SR
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Primary Outcome(s)
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Change in cognitive impairment level
[Time Frame: Up to 24 months]
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Secondary Outcome(s)
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Experience of women with cancer-related cognitive impairment in cancer
[Time Frame: Up to 24 months]
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Methylphenidate effect on fatigue
[Time Frame: Up to 24 months]
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Methylphenidate side effects
[Time Frame: Up to 24 months]
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Secondary ID(s)
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2016-MPH-02-3006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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