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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 1, 2026 → Dec 1, 2026
See other at-risk trials from Tel-Aviv Sourasky Medical Center

Record History

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  1. Primary completion pushed from Sep 1, 2026 to Dec 1, 2026
    • Study completion pushed from Sep 30, 2026 to Dec 30, 2026
    • Eligibility criteria expanded, about 10 words
  2. Eligibility criteria shortened, about 1 wordv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07759193
Lead Sponsor Tel-Aviv Sourasky Medical Center
Conditions
(from sponsor)		 Reconstructive Surgical Procedures, Free Tissue Flaps, Head and Neck Cancer, Perioperative Care
Related terms Head and Neck Neoplasms
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov