Clinical trial · Interventional
Effect of Methylphenidate on Cancer-related Cognitive Impairment
Étude Pilote de Phase II Sur l'Effet du méthylphénidate Sur la Fonction Cognitive Des Patientes en rémission d'un Cancer du Sein
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Cancer-Related Condition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methylphenidate HCl 10Mg SR | Drug | — | UNRESOLVED |
| Placebo Group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Methylphenidate HCl 10Mg SR
- description
- 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.
- interventionNames
- Drug: Methylphenidate HCl 10Mg SR
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- description
- 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.
- interventionNames
- Drug: Placebo Group
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available