Changes in body composition during and after pelvic radiotherapy

Conditions: Female genital neoplasms: cervical-, vulvar-, endometrial- or vaginal cancer MalnutritionSarcopenia

Registration Number: NL-OMON26194

Lead Sponsor: Amsterdam UMC, location AMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 33

Inclusion Criteria

•Aged = 18 years
•Scheduled for EBRT with curative intent for histologically confirmed cervical-, endometrial-, vulvar-, or vaginal cancer
•Written informed consent

Exclusion Criteria

•Inability to read and write Dutch

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference fat free mass percentage point as measured by CT-scan between baseline and the six-month of follow up.

Secondary Outcome Measures

Name	Time	Method
•Social participation (recovery) measured by PROMIS questionnaire: ability to participate in social roles and activities v2.0 Short form 8a.<br>•Nutritional status and gastrointestinal symptoms will be assessed by:<br>Data collection part of standard of care:<br>-Body mass index (BMI)<br>-Short Nutritional Assessment Questionnaire (SNAQ)-score<br>-Gastro-intestinal symptoms (EORTC-C30 and CX-24)<br>-Gastro-intestinal morbidity (CTCAE v5.0 rectum/sigmoid and colon/bowel)<br>Data collection part of study procedures:<br>-Fat free mass and fat mass (Bio-elektrische Impedantie Analyse; BIA)<br>-Mid-arm muscle circumference incl. skinfold measurement (muscle mass and percentage)<br>•Dietetic care will be evaluated by:<br>-Referral rates to dietary care.<br>-Waiting time for dietary care.<br>-Percentage of patients who withdraw from nutritional care.<br>-Reasons for withdraw from dietetic care by qualitative assessment of reasons for withdraw from nutritional care will be performed. <br>