Energy Expenditure Assessment in Head and Neck Cancer Patients Treated With Free Flap Surgery

NCT07759193 | Recruiting

• 1 other identifier: 0420-24TLV
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

What is the purpose of this study? Patients with head and neck cancer who undergo surgery with free flap reconstruction often need careful nutritional support during recovery. The purpose of this study is to better understand how much energy (calories) these patients need before and after surgery and whether nutrition is related to recovery, complications, and overall outcomes. Who can participate? Adults (18 years and older) with head and neck cancer who are scheduled to undergo free flap reconstructive surgery at Tel Aviv Sourasky Medical Center may be invited to participate. What will participants do? Participants will undergo several nutrition-related assessments before and after surgery, including: Indirect calorimetry tests, which measure how much energy the body uses. Body composition measurements using a non-invasive device. A questionnaire about food intake. Collection of routine clinical information, laboratory results, and recovery data from medical records. The indirect calorimetry assessments will be performed before surgery, several days after surgery, before hospital discharge, and approximately one month after discharge. What are the possible benefits of the study? The information obtained may help researchers better understand the nutritional needs of patients with head and neck cancer undergoing major surgery. This knowledge may improve nutritional care and recovery for future patients. Will participation affect medical care? Participation in the study will not change the standard medical or nutritional care patients receive. Nutritional follow-up will continue according to routine clinical practice. How will privacy be protected? Study data will be stored in a coded form, and access will be limited to authorized study personnel. Personal identifying information will be kept separate from the research database.

Conditions

Reconstructive Surgical Procedures; Free Tissue Flaps; Head and Neck Cancer; Perioperative Care

Outcome Measures

Primary Outcomes (1)

• Energy expenditure measured by indirect calorimetry.

  Measured energy expenditure compared with ESPEN nutritional recommendations for oncology patients.

  From baseline (pre-surgery) to approximately 1 month after hospital discharge

Study Arms (1)

Free Flap Reconstruction Cohort

EXPERIMENTAL

Device: Indirect Calorimetry (Diagnostic Test)

Interventions

Indirect Calorimetry (Diagnostic Test) DEVICE

indirect calorimetry will be used to measure resting energy expenditure in adult patients with head and neck cancer undergoing free flap reconstruction surgery. Assessments will be performed before surgery, several days after surgery, before hospital discharge, and approximately one month after discharge. The results will be used to characterize patients' energy requirements and nutritional profile throughout the perioperative period.

Free Flap Reconstruction Cohort

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Availability of indirect calorimetry measurements, nutritional data, postoperative complications data, and follow-up information.
• Ability and willingness to provide informed consent.

You may not qualify if:

• Age younger than 18 years. Pregnant women. Children. Individuals unable to provide informed consent. Vulnerable populations as defined by local regulations. Death before completion of study assessments.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Ichilov Hospital

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Calorimetry, Indirect; Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Calorimetry; Chemistry Techniques, Analytical; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Anton Waeshavsky MD

CONTACT

+972505628629; anton.warshavsky@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 12, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)