Clinical trial · Interventional
Energy Expenditure Assessment in Head and Neck Cancer Patients Treated With Free Flap Surgery
Indirect Calorimetry Profile for Surgically Free Flap Treated Head and Neck Oncologic Patients: A Prospective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Free Tissue Flaps | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Perioperative Care | — | UNRESOLVED | — |
| Reconstructive Surgical Procedures | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indirect Calorimetry (Diagnostic Test) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Free Flap Reconstruction Cohort
- interventionNames
- Device: Indirect Calorimetry (Diagnostic Test)
Primary outcomes (1)
- measure
- Energy expenditure measured by indirect calorimetry.
- timeFrame
- From baseline (pre-surgery) to approximately 1 month after hospital discharge
- description
- Measured energy expenditure compared with ESPEN nutritional recommendations for oncology patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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. * Individuals unable to provide informed consent. * Vulnerable populations as defined by local regulations. * Death before completion of study assessments.
References
Publications (0)
Data not yet available