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Nutritional assessment and prehabilitation in gynaecological cancers

Nutritional assessment of women with gynaecological cancers and impact of focused prehabilitation protocol on nutrition and perioperative outcomes after interval debulking surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053552
Enrollment
160
Registered
2023-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

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

Interventions

Intervention1: Multimodal prehabilitation program: In the study, a subset of 30 women with advanced epithelial ovarian cancer receiving neoadjuvant therapy will receive a multimodal prehabilitation pr

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Number of patients with stage 1 and stage 2 malnutrition by GLIM criteria 2. Number of patients with stage B and stage C malnutrition by PG-SGA Globalmassessment categories 3. Number of patients with stage 1, 2 malnutrition GLIM criteria at the time of Interval debulking surgery, after prehabilitation 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 2. At baseline 3. At 8 weeks 4. At 12 weeks

Secondary

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

Countries

India

Contacts

Public ContactSaroj Rajan

All India Institute of Medical Sciences, New Delhi

drseemasinghal@gmail.com9818291001

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026