Preoperative lifestyle intervention for breast cancer patients
FeAsibility of a PReoperative, Multimodal Lifestyle InterventiOn in Patients With Breast Cancer ReceivIng Neoadjuvant Chemotherapy
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 11 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT06266312 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with stage I-III breast cancer eligible for neoadjuvant chemotherapy.
Not a fit: Patients with HER2-positive tumors or conditions that severely limit physical exercise may not benefit from this intervention.
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 performed: Other studies have shown promising results with multimodal prehabilitation approaches in cancer care, suggesting potential for success in this intervention.
Eligibility criteria
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 this trial is running
Maastricht, Limburg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.