Energy Expenditure Assessment in Head and Neck Cancer Patients Treated With Free Flap Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorTel-Aviv Sourasky Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age younger than 18 years.
Pregnant women.
Individuals unable to provide informed consent.
Vulnerable populations as defined by local regulations.
Trial design
Design model
Single group
Treatments tested in this trial
Indirect Calorimetry (Diagnostic Test)
Deviceindirect 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.
Treatment groups
19 Participants
are divided into 1 treatment groupGroup A: Free Flap Reconstruction CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 dischargeSponsors and contacts
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Source ClinicalTrials.gov