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NCT Number: NCT07759193

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

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 18 years or older. Diagnosis of head and neck cancer. Scheduled to undergo or have undergone free flap reconstruction surgery at Tel Aviv Sourasky Medical Center.

Availability of indirect calorimetry measurements, nutritional data, postoperative complications data, and follow-up information.

Ability and willingness to provide informed consent.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

  1. Energy expenditure measured by indirect calorimetry.

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Anton Waeshavsky MD

CONTACT

[email protected]

+972505628629

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Official study title

Indirect Calorimetry Profile for Surgically Free Flap Treated Head and Neck Oncologic Patients: A Prospective Cohort Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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