utritional assessment and prehabilitation in gynaecological cancers

Not Applicable

• Conditions: Health Condition 1: C51-C58- Malignant neoplasms of female genital organs

• Registration Number: CTRI/2023/06/053552
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Women with advanced epithelial ovarian cancer receiving neoadjuvant therapy.

2. Able to give informed written consent.

3. Eastern Cooperative Oncology Group Performance Score 0-3

Exclusion Criteria

1. Pre-existing inflammatory disorder: major infections, burns, decubitus, open wounds, or fistula; acute trauma; chronic organ diseases, like congestive heart failure, rheumatoid arthritis, chronic kidney, or liver disease, AIIDS

2. Pre diagnosed myopathy

3. Pre diagnosed malabsorption syndromes

4. Patients who have received pulse steroid therapy in last 30 days

5. History of major surgery in the past 30 days

6. Patients with a final pathological diagnosis of benign disease will be excluded during data analysis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Number of patients with stage 1 and stage 2 malnutrition by GLIM criteria <br/ ><br>2. Number of patients with stage B and stage C malnutrition by PG-SGA Globalmassessment categories <br/ ><br>3. Number of patients with stage 1, 2 malnutrition GLIM criteria at the time of Interval debulking surgery, after prehabilitation <br/ ><br>4. Correlation of GLIM criteria with short term surgical outcomes, and postoperative complications using Clavien-Dindo classification within 30 days of surgeryTimepoint: 1. At baseline <br/ ><br>2. At baseline <br/ ><br>3. At 8 weeks <br/ ><br>4. At 12 weeks

Secondary Outcome Measures

Name	Time	Method
Correlation of GLIM criteria with short term surgical outcomes, including <br/ ><br>duration of hospital stay; estimated blood loss; requirement for blood transfusion; <br/ ><br>intraoperative complications (including unintended bladder, bowel, ureteric or <br/ ><br>vascular injury); postoperative complications using Clavien-Dindo classification within 30 days of surgeryTimepoint: 1 month after surgery