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Octreotide drug compared with diet Restriction in treating Chyle Leak in Head and Neck Cancer Patients

Randomized controlled trial comparing Octreotide with standard treatment diet restriction versus standard treatment for chyle leak in head and neck cancer patients - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063582
Enrollment
40
Registered
2024-03-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Health Condition 1: C760- Malignant neoplasm of head, face and neck

Interventions

Intervention1: Octreotide with diet restriction standard of care: Once Chyle leak identified Octreotide 100mcg injection in 1 ml ampule is give thrice daily TDS subcutaneously in lateral arm or abdome

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Head and neck cancer patients with neck dissection developing chyle leak in postoperative period as per clinical assessment milky white drain fluid or biochemical analysis -Eastern Cooperation Oncology Group performance status 0 to 2

Exclusion criteria

Exclusion criteria: -Those patients who are considered unfit for the surgery in view of -Abnormal Renal Liver function -Uncontrolled DM, HTN more than or equal to 140 by 90 mmHg after appropriate medication -Cardiac abnormality- Ischemic heart disease Ejection fraction less than 50 percent -Any past history of gastric or duodenal ulcer -Allergic to Octreotide

Design outcomes

Primary

MeasureTime frame
Duration of chyle fistula closure Date of randomization to drain output less or equal to 10 mlTimepoint: 7 days

Secondary

MeasureTime frame
-Mean drain output in the two groups -Neck infection -Other intervention if needed Surgery IR TPN Timepoint: 60 months

Countries

India

Contacts

Public ContactPoonam Joshi

Tata Memorial Centre

drpoonamjoshitmh@gmail.com9769143523

Outcome results

None listed

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