NCT04022044CompletedNot Applicable
Postoperative Changes in Head and Neck Cancer Patients Undergoing Surgery
Cliniques universitaires Saint-Luc- Université Catholique de Louvain0 sites24 target enrollmentStarted: December 30, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Primary Endpoint
- Change in functional exercise capacity
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Change in functional exercise capacity
Time Frame: Assessments one day before surgery, 1 and 3 months postoperative
Functional exercise capacity is measured by a 6-minute walk test
Secondary Outcomes
- Change in hand grip strength(Assessments one day before surgery, 1 and 3 months postoperative)
- Change in health-related quality of life(Assessments one day before surgery, 1 and 3 months postoperative)
- Change in upper body strength and endurance(Assessments one day before surgery, 1 and 3 months postoperative)
- Change in muscle fatigability(Assessments one day before surgery, 1 and 3 months postoperative)
- Change in flexibility(Assessments one day before surgery, 1 and 3 months postoperative)
- Change in blood pressure(Assessments one day before surgery, 1 and 3 months postoperative)
- Change in waist circumference(Assessments one day before surgery, 1 and 3 months postoperative)
- Change in common symptom batteries in cancer patients(Assessments one day before surgery, 1 and 3 months postoperative)
- Change in nutritional status(Assessments one day before surgery, 1 and 3 months postoperative)
- Change in weight(Assessments one day before surgery, 1 and 3 months postoperative)
- Change in fat body mass(Assessments one day before surgery, 1 and 3 months postoperative)
Investigators
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