Clinical trial NCT06073717: Motor-cognitive Training Effects on Cognition in Breast Cancer Survivors: the BRAINonFIT Study (BRAINonFIT).
Official title: Motor-cognitive Training Effects on Cancer-related Cognitive Impairment and Muscle-brain Crosstalk Biomarkers in Breast Cancer Survivors: the BRAINonFIT Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Survivors
Cognitive Impairment
Executive Dysfunction
Keywords: Cancer-related Cognitive Impairment
Physical exercise
dual motor-cognitive tasks
cognitive stimulation
Neurocognitive disorders
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 108
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study has been designed as a randomised, controlled, longitudinal (20 weeks), three-arm, parallel study with a follow-up phase (12 weeks).
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this interventional study is to assess the effects of either physical exercise program or combined with cognitive training (dual motor and cognitive training program) on breast cancer survivors. The main questions it aims to answer are:

* Analyze the effectiveness of a supervised dual-task training program or a physical exercise program on the executive functions of the participants.
* Evaluate the impact of both interventions on physical function, emotional aspects, and important biomarkers related to muscle-brain crosstalk.

Participants will perform a 20-week supervised and controlled program, three times a week, along with weekly calorie and step challenges.

Researchers will compare the dual-task training group, with the physical exercise group, and with a control group, which will perform the guideline recommendations of physical activity (non-supervised) to see how these intervention approaches can impact cognitive functions, physical functions, emotional aspects, and biomarkers related to muscle-brain crosstalk.

Assessments will take place at three-time points: at baseline, after the intervention (20 weeks post-baseline) and after a 12-week follow-up period (32 weeks post-baseline).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with stage I-IIIA breast cancer
* Completed primary treatment, including surgery, radiotherapy and/or chemotherapy
* Scheduled to receive adjuvant endocrine therapy, or currently receiving adjuvant endocrine therapy
* Without functional limitations or other illnesses that condition and prevent them from practising intense physical exercise
* FACT-Cog questionnaire score ≥ 10th percentile considering age groups
* Fluency in Spanish (spoken and written)

Exclusion Criteria:

* Undergoing radiotherapy and/or chemotherapy
* FACT-Cog questionnaire score ≤ 10th percentile considering age groups
* Congenital heart disease
* Chronic lung disease
* Severe psychiatric disorders
* History of substance abuse, or dependence (other than tobacco)
* Mood disorders require treatment (anxiety or depression)
* Relapses (2-3 months before the study start)

Primary outcomes:
measure: Executive Function (Cognitive Flexibility and Processing Speed)
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary outcomes:
measure: Inhibitory Control and Concentration
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
measure: Verbal Intelligence, Non-verbal Intelligence, Verbal memory, and Non-verbal Memory
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
measure: Learning Ability
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
measure: Perceived Cognitive Functions
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
measure: Max. Oxygen Consumption
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
measure: Muscular Strength of shoulder and knee extensors
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
measure: Range of Movement
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
measure: Forced Vital Capacity (FVC) and Forced Expiratory Volume (FEV)
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
measure: Volume of physical activity
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
measure: Intensity of Physical Activity
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
measure: Weight and Height
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
measure: Brain-Derived Neurotrophic Factor (BDNF), Vascular Endothelial Growth Factor (VEGF), Fibroblast Growth Factor 17 (FDF-17), Soluble Klotho (S-KL)
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
measure: Fatigue
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
measure: Pain Scale
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
measure: Depression
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
measure: Anxiety
timeFrame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: SADUS - Servicio de Actividades Deportivas de la Universidad de Sevilla
city: Sevilla
country: Spain
facility: Laboratorio de Ciencias del Deporte
city: Sevilla
country: Spain
facility: Oncoavanze
Study officials:
affiliation: University of Seville
name: Matilde Mora Fernández, PhD
role: STUDY_DIRECTOR
affiliation: University of Seville
name: Luis Carrasco Páez, PhD
role: STUDY_DIRECTOR
affiliation: University of Seville
name: Jesús Orellana Jaén
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jesus OJ, Luis CP, Matilde MF. Effects of exercise on cancer-related cognitive impairment in breast cancer survivors: a scoping review. Breast Cancer. 2023 Nov;30(6):885-909. doi: 10.1007/s12282-023-01484-z. Epub 2023 Jul 22.