Exercise during chemotherapy for breast cancer

Physical Exercise During Neoadjuvant Chemotherapy for Breast Cancer as a Means to Increase Pathological Complete Response Rates: the Randomized Neo-ACT Trial

This study tests if a structured exercise program during chemotherapy can help women with breast cancer feel better and improve their treatment results.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 712 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Karolinska Institutet (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 13 sites (Melbourne and 12 other locations)
• Trial ID: NCT05184582 on ClinicalTrials.gov

What this trial studies

This trial investigates the effects of a physical exercise intervention during neoadjuvant chemotherapy for breast cancer. Participants will engage in a structured exercise program tailored to their fitness levels, aiming to enhance their tolerance to treatment and improve oncological outcomes. The primary focus is on increasing the rate of pathological complete response (pCR), while secondary outcomes include assessing residual cancer burden, quality of life, and treatment-related toxicities. The exercise regimen will be supported by a mobile application and local physiotherapists over approximately five months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with primary invasive breast cancer who are about to start neoadjuvant chemotherapy.

Not a fit: Patients with conditions that prevent safe exercise participation or those already meeting high exercise thresholds may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and quality of life for breast cancer patients undergoing chemotherapy.

How similar studies have performed: Other studies have shown promising results with exercise interventions during cancer treatment, suggesting potential benefits in this area.

Eligibility criteria

Inclusion Criteria:

* Patients with primary invasive breast cancer cT1-T3 cN0-2
* Full tumour biology available before initiation of NACT
* Oral and written consent
* Age ≥ 18 years

Exclusion Criteria:

* Pregnancy or breast-feeding
* Bilateral invasive breast cancer
* The presence of musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise demands of the study
* Currently performing equal to or more than 150 mins of moderate to high intensity aerobic exercise and 2 sessions per week of moderate intensity resistance exercise

Where this trial is running

Melbourne and 12 other locations

• Cabrini Health — Melbourne, Australia (Not_yet_recruiting)
• Helsinki University Hospital — Helsinki, Finland (Recruiting)
• Turku University Hospital — Turku, Finland (Not_yet_recruiting)
• Karolinska University Hospital — Stockholm, Stockholm County, Sweden (Recruiting)
• Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
• Skaraborgs sjukhus — Lidköping, Sweden (Recruiting)
• Capio St Görans Hospital — Stockholm, Sweden (Recruiting)
• Southern General Hospital — Stockholm, Sweden (Recruiting)
• Sundsvall Hospital — Sundsvall, Sweden (Recruiting)
• Umeå University Hospital — Umeå, Sweden (Recruiting)
• Västmanlands Hospital — Västerås, Sweden (Recruiting)
• Edinburgh Napier University — Edinburgh, Scotland, United Kingdom (Not_yet_recruiting)
• Royal Marsden — London, United Kingdom (Not_yet_recruiting)

Study contacts

• Principal investigator: Jana de Boniface — Karolinska Institutet
• Study coordinator: Jana de Boniface

Conditions Breast Cancer