Ichilov Hospital
Tel Aviv, Israel
Location status: Recruiting
NCT Number: NCT07759193
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.
Interested in participating?
Request Info18 year–120 year
All sexes
Interventional
Not applicable
Tel Aviv, Israel
Location status: Recruiting
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.
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.
Time frame: From baseline (pre-surgery) to approximately 1 month after hospital discharge
Measured energy expenditure compared with ESPEN nutritional recommendations for oncology patients.
Contact information is provided by the study sponsor or research team.
Tel-Aviv Sourasky Medical Center
Other Gov
Indirect Calorimetry Profile for Surgically Free Flap Treated Head and Neck Oncologic Patients: A Prospective Cohort Study
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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