Effect of Methylphenidate on Cancer-related Cognitive Impairment

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Québec, CHU de Québec; CHU de Quebec-Universite Laval
• Collaborators: Équipe de Recherche Michel-Sarrazin en Oncologie psychosociale et Soins palliatifs; Fondation Hôtel-Dieu de Lévis; Purdue Pharma LP
• Treatments: Methylphenidate

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 (≤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.