Reconstructive Surgical ProceduresNCT07759193
Energy Expenditure Assessment in Head and Neck Cancer Patients Treated With Free Flap Surgery
A study testing Indirect Calorimetry (Diagnostic Test) in people with Reconstructive Surgical Procedures and Free Tissue Flaps, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Reconstructive Surgical Procedures, Free Tissue Flaps, Head and Neck Cancer
- What is being tested?
- Indirect Calorimetry (Diagnostic Test)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Ichilov Hospital
Tel Aviv
Efrat Haruoch Harouch, +972542212822, efrathe@tlvmc.gov.il
About this study
Official title: Indirect Calorimetry Profile for Surgically Free Flap Treated Head and Neck Oncologic Patients: A Prospective Cohort Study
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.
Read more
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
- Reconstructive Surgical Procedures, Free Tissue Flaps, Head and Neck Cancer, Perioperative Care
- Being tested
- Indirect Calorimetry (Diagnostic Test)
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect Calorimetry (Diagnostic Test)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Free Flap Reconstruction Cohort | Experimental | Not described Receives: Device: Indirect Calorimetry (Diagnostic Test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure measured by indirect calorimetry.
Measured energy expenditure compared with ESPEN nutritional recommendations for oncology patients.
Measured: From baseline (pre-surgery) to approximately 1 month after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Jan 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstructive Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shmuel Kivity, MD, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759193
- Sponsor's protocol ID
- 0420-24TLV
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Calorimetry Profile for Surgically Free Flap Treated Head and Neck Oncologic Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07759193
- Acronym / sponsor ID
- 0420-24TLV
- Conditions
- Reconstructive Surgical Procedures, Free Tissue Flaps, Head and Neck Cancer, Perioperative Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Free Flap Reconstruction Cohort | Experimental | Device: Indirect Calorimetry (Diagnostic Test) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Free Flap Reconstruction Cohort |
Primary outcome
Energy expenditure measured by indirect calorimetry.
Time frame: From baseline (pre-surgery) to approximately 1 month after hospital discharge
Measured energy expenditure compared with ESPEN nutritional recommendations for oncology patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect Calorimetry (Diagnostic Test) in people with Reconstructive Surgical Procedures and Free Tissue Flaps, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anton Waeshavsky MD (+972505628629, anton.warshavsky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure measured by indirect calorimetry. (time frame: From baseline (pre-surgery) to approximately 1 month after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.