Exercise for breast cancer patients undergoing neoadjuvant chemotherapy: the BENEFIT study

Recruiting

Conditions: Breast cancer mamma carcinoma
10006291

Registration Number: NL-OMON52607

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 9

Inclusion Criteria

• Unilateral or bilateral primary carcinoma of the breast, confirmed
histologically by core biopsy
• Scheduled for neoadjuvant chemotherapy (but not yet started)
• Confirmed hormone receptor (HR) and Her2 status
• Women >= 18 years of age
• Sufficient Dutch language skills
• Willing to be randomly assigned to one of the three study arms
• Signed informed consent

Exclusion Criteria

• Any physical or mental conditions that would hamper the performance of the
training programs or the completion of the study procedures
• Engaging in systematic intense exercise training (at least 1h twice per week)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>• % change in tumor size </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>• Clinical-pathologic stage (CPS-EG) score<br /><br>• Pathologic Complete Response (pCR)<br /><br>• Chemotherapy compliance (reduced, delayed or permanently stopped therapy)<br /><br>• Quality of life (EORTC QLQ-C30, -CIPN20 and -BR23), overall, functions and<br /><br>symptoms<br /><br>• Fatigue (EORTC-FA13), total and subscores<br /><br>• Sleep problems (PSQI)<br /><br>• Depression and anxiety (PHQ-4)<br /><br>• Return to work<br /><br>• Endurance (VO2peak)<br /><br>• Body weight, hip and waist circumference, and BMI<br /><br>• Tumor markers, e.g. ki-67 (from clinical routine measures)<br /><br>• Biomarkers of cancer risk and progression (e.g. angiogeneic factors,<br /><br>inflammatory parameters)<br /><br>• Hb value</p><br>