An interventional study of Indirect Calorimetry (Diagnostic Test) in Reconstructive Surgical Procedures, Free Tissue Flaps and Head and Neck Cancer, sponsored by Tel-Aviv Sourasky Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Supportive care
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 19 is below the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 554 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Indirect Calorimetry (Diagnostic Test)
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.
Energy expenditure measured by indirect calorimetry.
Measured energy expenditure compared with ESPEN nutritional recommendations for oncology patients.
Time frame: From baseline (pre-surgery) to approximately 1 month after hospital discharge
Plan to share: No
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