Physical Activity and Dietary intervention in OVArian cancer (PADOVA): a RCT evaluating effects on body composition, physical function, and fatigue

Completed

Conditions: Ovarian cancer
10038594

Registration Number: NL-OMON55552

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 122

Inclusion Criteria

Women (aged >= 18 years) who are scheduled for (neo)adjuvant first-line
chemotherapy treatment for histologically confirmed primary epithelial
ovarian-, fallopian tube or extra-ovarian cancer.

Exclusion Criteria

- not being able to perform basic activities of daily living
- cognitive disorder or severe emotional instability (e.g. schizophrenia,
Alzheimer)
- contraindications of exercise (e.g. heart failure)
- inability to read and write Dutch
- life expectancy < 3 months
- participating in another exercise and/or dietary intervention study
- have had any other type of cancer within the last 5 years.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcomes are body composition, physical function and fatigue.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include physical activity and fitness, body mass index,<br /><br>dietary intake, health-related quality of life and symptoms related to ovarian<br /><br>cancer and its treatment (pain, fatigue, nausea/vomiting, neuropathy), anxiety<br /><br>and depression, blood samples, sleep disturbances and chemotherapy completion<br /><br>rates.<br /><br>Additionally, an extensive process evaluation will be conducted to examine how<br /><br>and why the intervention was (un)successful. Clinical parameters (e.g. FIGO<br /><br>stage, comorbidities and survival) will be collected from medical records.<br /><br>Blood will be drawn for future analyses to examine biological mechanisms<br /><br>linking exercise to clinical outcomes, such as reduced inflammation, improved<br /><br>immune function, vascularization and perfusion, and insulin-like growth<br /><br>factor-axis.</p><br>