Cognitive Training and Exercise for Women With Breast Cancer and Cognitive Impairment (CHEMO-CogEx)

Universidad de Extremadura

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Other: Cognitive training; Other: Psychoeducational therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07017530

CEI 044/23

Details and patient eligibility

About

Chemotherapy-related cognitive impairment is a prevalent and distressing condition among breast cancer survivors, adversely affecting memory, attention, and overall cognitive function, thereby diminishing quality of life. Emerging evidence suggests that multimodal interventions combining cognitive training and adapted physical exercise may mitigate these cognitive deficits and associated symptoms. This study aims to evaluate the efficacy of a 12-week structured intervention integrating cognitive training and supervised physical exercise in improving cognitive function, fatigue, sleep quality, psychological distress, and overall well-being in women with breast cancer. Furthermore, it seeks to determine the optimal timing for such interventions to maximize their effectiveness. A randomized controlled trial involving 220 participants will assess subjective and objective cognitive outcomes, brain activity, and physical performance. The findings from this research may contribute to the development of evidence-based rehabilitation strategies, enhancing cognitive health and quality of life in breast cancer patients.

Enrollment: 220 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 18 years or older who were diagnosed with stage 0 to IV breast cancer.
• Women undergoing chemotherapy (at least two cycles) or having completed it at least six months earlier.
• Cognitive impairment must be reported, with scores below 54 on the FACT-Cog scale

Exclusion criteria

• Women with significant neurological conditions.
• Women with psychiatric conditions.
• Women with contraindications for physical exercise.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

220 participants in 4 patient groups

Cognitive training + exercise group during chemotherapy

Experimental group

Description:

Al list two cycles of chemotherapy.

Treatment:

Other: Cognitive training

Cognitive training + exercise group after chemotherapy

Experimental group

Description:

Al list six months after the completion of chemotherapy.

Treatment:

Other: Cognitive training

Psychoeducational therapy during chemotherapy

Active Comparator group

Description:

Al list two cycles of chemotherapy.

Treatment:

Other: Psychoeducational therapy

Psychoeducational therapy after chemotherapy

Active Comparator group

Description:

Al list six months after the completion of chemotherapy.

Treatment:

Other: Psychoeducational therapy