FeAsibility of a PReoperative, multimodal lifestyle InterventiOn in patients with breast cancer ReceivIng neoadjuvant chemotherapy (APRIORI-study)

Conditions: Breast cancer
mammary cancer
10006291

Registration Number: NL-OMON56667

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 11

Inclusion Criteria

• Patients diagnosed with stage I-III breast cancer eligible for neoadjuvant
intravenous chemotherapy at the Maastricht University Medical Center
• Aged >=18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
grade 0-1 (Table 1) [40,41]
• Enough understanding of the Dutch language

Exclusion Criteria

• Human Epidermal growth factor Receptor 2 (HER2) - positive tumour
• Scalp cooling
• Recurrent breast cancer
• 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 & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is the feasibility of the multimodal<br /><br>lifestyle intervention with respect to recruitment, adherence, drop-out, safety<br /><br>and acceptance.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters are Fatigue (Multidimensional Fatigue Index,<br /><br>MFI-20), cardiorespiratory fitness (WRpeak on modified Steep Ramp Test), Muscle<br /><br>Strength (1-Repetition Maximum on leg press, chest press, abdominal crunch and<br /><br>lateral pulldown strength equipment), and nutritional status (Patient Generated<br /><br>Subjective Global Assessment (PG-SGA) short form, weight (kg), height (cm),<br /><br>energy and protein intake, energy and protein requirements, circumference of<br /><br>upper arm and waist).</p><br>