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Postoperative Changes in Head and Neck Cancer Patients Undergoing Surgery

Postoperative Changes in Head and Neck Cancer Patients Undergoing Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04022044
Enrollment
24
Registered
2019-07-16
Start date
2014-12-30
Completion date
2019-06-14
Last updated
2019-07-16

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

Conditions

Head and Neck Cancer

Brief summary

The aim of this study is to evaluate the postoperative changes after a major surgery in head and neck cancer patients. Each participant will be evaluated three times: (1) One day before surgery; (2) one month postoperative and (3) three months postoperative. Assessments included blood pressure, anthropometric measurements, physical measurements and questionnaires on quality of life, nutritional status and cancer symptoms.

Interventions

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of head and neck cancer patients planned for an elective major surgery * More than 18 years of age * Able to read, write and understand French

Exclusion criteria

\- Neurological or orthopedic impairments not suitable for testing

Design outcomes

Primary

MeasureTime frameDescription
Change in functional exercise capacityAssessments one day before surgery, 1 and 3 months postoperativeFunctional exercise capacity is measured by a 6-minute walk test

Secondary

MeasureTime frameDescription
Change in flexibilityAssessments one day before surgery, 1 and 3 months postoperativeFlexibility is measured by Toe touch test
Change in upper body strength and enduranceAssessments one day before surgery, 1 and 3 months postoperativeUpper body strength and endurance are measured by the 30-second arm curl test
Change in hand grip strengthAssessments one day before surgery, 1 and 3 months postoperativeHand grip strength test is performed using a Jamar® dynamometer
Change in health-related quality of lifeAssessments one day before surgery, 1 and 3 months postoperativeHealth-related quality of life is evaluated with the version 4 of the University of Washington head and neck cancer questionnaire
Change in common symptom batteries in cancer patientsAssessments one day before surgery, 1 and 3 months postoperativeCommon symptom batteries is measured by the Edmonton Symptom Assessment System (revised version) questionnaire
Change in muscle fatigabilityAssessments one day before surgery, 1 and 3 months postoperativeMuscle fatigability is measured using a Cybex dynamometer
Change in blood pressureAssessments one day before surgery, 1 and 3 months postoperativeResting blood pressure is measured using the M6 Comfort automatic blood pressure monitor
Change in weightAssessments one day before surgery, 1 and 3 months postoperativeWeight (kg) is measured by using a bioelectrical impedance analysis
Change in fat body massAssessments one day before surgery, 1 and 3 months postoperativeFat body mass (%) is measured by using a bioelectrical impedance analysis
Change in waist circumferenceAssessments one day before surgery, 1 and 3 months postoperativeWaist circumference is measured with a non-elastic tape measure
Change in nutritional statusAssessments one day before surgery, 1 and 3 months postoperativeNutritional status is measured with the Short Nutritional Assessment Questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026