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Food and Exercise before oral cancer surgery

Nutritional and physical prehabilitation in patients with oral cancer scheduled for combined approach resection: a pilot study - Prehabilitation in patients with planned surgery for oral cancer; a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON61364
Enrollment
20
Registered
2025-05-16
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral cancer Oral cancer

Interventions

Prehabilitation by a personalized nutritional treatment including the use of two daily portions of Fortifit Energy®&nbsp
combined with moderate to high-intensity personalized physical exercises 3 to 5 weeks before OSCC combined approach resection. The physical exercise program will be supervised three times per week by

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subject must undergo major combined approach surgery for oral cancerLow skeletal muscle mass (SMM), based on CT or MRI scans of the head and neck area at level C3Karnofsky Performance status >60Able to walk =60 m without a mobility aid18 years or olderSufficient Dutch writing and reading skills

Exclusion criteria

Exclusion criteria: Patients exercising more than in the prescribed physical exercise intervention of this studyFor patients participating in the physical exercise and nutritional intervention: <2 weeks to participate in the study interventionPatients unwilling to undergo a CT scan following the physical exercise and nutritional prehabilitation intervention.

Design outcomes

Primary

MeasureTime frame
Skeletal muscle mass measurement 

Secondary

MeasureTime frame
Physical fitness6-minutes walking test (6MWT)Steep Ramp Test (SRT) Physical muscle strengthGrip strength will be assessed by the JAMAR grip strength dynamometer®Lower and upper muscle strength – assessed by microFET® hand held dynamometer according to standardized procedures30s chair stand test, i.e. the number of completed stand ups on the patients’ fastest pace over a 30-second period8-RM testing of the major muscle groups (arms, legs, shoulders and core) Physical activityPhysical activity will be measured using the Activ8 and SQUASH questionnaire: The Activ8 is an accelerometer to measure physical activity objectively The SQUASH is a survey that assesses physical activity in relation to commuting, leisure time, household chores, and activity at work and school. Body compositionFat-Free Mass (FFM) will be calculated with the Kyle equation using Resistance and Reactance at 50kHz measured by Bioelectrical Impedance Analysis (BIA).35Both methods assess body composition by measuring resistance (R) and reactance (Xc) through capacitance of a current through cells. The impedance of the body is largely determined by the low-impedance lean tissues. The Kyle equation showed reasonable validity in patients with HNSCC.36 BIA will be performed at UMC Utrecht using the Bodystat® QuadScan 4000, a multifrequency BIA device. Air Displacement Plethysmography (BODPOD®); whole body density is based on the determination of body mass and body volume. The BODPOD® provides information about the amount of FM and FFM, in percentage and absolute amounts. In the BODPOD®, the system’s electronic scale is used to measure the subject’s mass. Subject’s volume is measured in the BOD POD® by air displacement plethysmography. Once the subject’s mass (Mb) and volume (Vb) are measured, body density (Db) can be calculated as follows: Db =  Mb/ Vb. The determination of body composition by densitometry is based on modeling the body into two compartments

Countries

Netherlands

Contacts

Public ContactC.M. Speksnijder

Universitair Medisch Centrum Utrecht

c.m.speksnijder@umcutrecht.nl0887568040

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 10, 2026