Changes in body composition during and after external beam radiotherapy for gynaecologic cancer

Changes in body composition during and after external beam radiotherapy for gynaecologic cancer - Changes in body composition during and after pelvic radiotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54998

Enrollment

Registered

2019-08-21

Start date

2020-05-14

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dietary deficiency Malnutrition

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: * Inability to read and write Dutch

Design outcomes

Primary

Measure	Time frame
Fat free mass index (FFMI) derived from CT-scan.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results