Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients With Breastcancer
Recruiting · NCT06266312 · Interventional (participants receive a specific treatment) · Lead sponsor: Maastricht University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 responses to a preoperative multimodal lifestyle intervention, on cardiorespiratory fitness, muscle strength, nutritional status, and fatigue in patients with breast cancer receiving neoadjuvant chemotherapy.
Who can take part
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 is running
1 location listed.
- Maastricht University Medical Center - Maastricht, Limburg, Netherlands