Recruiting

Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients With Breastcancer

The primary objective of this study is to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer with respect to recruitment, adherence, dropout, safety and acceptance. The secondary objective is to provide a preliminary evaluation of participant…

ClinicalTrials.gov IDNCT06266312

PhaseNA

Enrollment11

SponsorMaastricht University Medical Center

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer, Breast Neoplasms

About this study

Interventions

Behavioral: A multimodal prehabilitation programme — 1. During the weekly chemotherapy infusion (week 10-20), a supervised moderate-intensity endurance training (MIET) on a cycle ergometer is performed (11x): * 5 min. warm-up * 35 min. cycling at 40-60% of (HR reserve + resting HR) * 5-10 min. cool-down 2. \+ strength training During week 17-22 a supervised high-intensity interval training + strength training programme is performed (8x): HITT: * 3 min warm-up (20W) * 14 intervals (30sec. work intervals at 60% of WRpeak alternates with 60-sec. rest intervals at 20W) --1 min. cool-down Muscle strength: 4 exercises (leg press, chest press, abdominal crunch, lateral pulldown), 3 sets, 8-12 repetitions at 60% of 1-RM. 3\) During 4 consultations with a dietician (week 9, 15, 20, 22) nutritional intake is evaluated and advice is given on energy and protein requirements. Patients are advised to use a digital food diary to record their intake for ≥3 days a week.

Primary outcomes

Recruitment rate (%) (Week 0)
Characteristics of included participants (Week 0)
Attendance rate for MIET sessions (%) (Week 10-20)
Adherence rate, exercise relative dose intensity (ExRDI) MIET (%) (Week 10-20)
Reasons for not having executed a training session as intended (Week 10-20)
Attendance rate HIIT + strength sessions (%) (Week 17-22)
Adherence rate, ExRDI HIIT training (%) (Week 17-22)
Adherence rate, ErXDI strength training (%) (Week 17-22)

Eligibility information

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.

Study locations

Maastricht University Medical Center, Maastricht, Limburg 6229HX Netherlands

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.