Preoperative lifestyle intervention for breast cancer patients
Official title: FeAsibility of a PReoperative, Multimodal Lifestyle InterventiOn in Patients With Breast Cancer ReceivIng Neoadjuvant Chemotherapy
Run by Maastricht University Medical Center · NCT06266312 · Data updated 2026-11-12
This study is testing a new program that combines exercise and nutrition to see if it helps breast cancer patients feel stronger and healthier before their surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 11 (estimated) |
| Sponsor | Maastricht University Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Maastricht, Limburg) |
| Status | Recruiting |
| Started | May 27, 2024 |
| Main results expected | November 1, 2025 |
| Study ends | November 1, 2025 |
| Registry record updated | February 20, 2025 |
| Trial ID | NCT06266312 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older diagnosed with stage I-III breast cancer eligible for neoadjuvant chemotherapy.
✕Probably not a fit
Patients with HER2-positive tumors or conditions that severely limit physical exercise may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the feasibility of a multimodal prehabilitation program for patients with breast cancer undergoing neoadjuvant chemotherapy. The program includes moderate-intensity endurance training during chemotherapy, high-intensity interval training, and strength training in the weeks leading up to surgery, along with nutritional guidance. The study aims to assess recruitment, adherence, safety, and participant acceptance, as well as evaluate preliminary effects on fitness, muscle strength, nutritional status, and fatigue. The goal is to optimize health outcomes during the preoperative period.
Why it matters
Potential benefit: If successful, this intervention could enhance physical fitness and overall health outcomes for breast cancer patients before surgery.
How similar studies have gone: Other studies have shown promising results with multimodal prehabilitation approaches in cancer care, suggesting potential for success in this intervention.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with stage I-III breast cancer eligible for neoadjuvant intravenous chemotherapy at the MUMC+ * Aged ≥18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status Scale grade 0-1 (Table 1) * Enough understanding of the Dutch language Exclusion Criteria: * Human Epidermal growth factor Receptor 2 (HER2) - positive tumour * Scalp cooling * Conditions that seriously hamper physical exercise * Incapacitated subjects as reported by the attending medical specialist in the medical record. When any doubt arises, the patient will not be considered eligible.
Where it's running
-
Maastricht University Medical Center
Maastricht, Limburg, Netherlands Recruiting
Study contacts
- Principal investigator: Hanneke Dijk - Huisman, PhD — Maastricht University Medical Center
- Study coordinator: Hanneke van Dijk - Huisman, PhD
- Email: hanneke.huisman@mumc.nl
- Phone: +31 43 3877146
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.