Head and Neck Cancer Clinical Trial
Official title:
Postoperative Changes in Head and Neck Cancer Patients Undergoing Surgery
Verified date | July 2019 |
Source | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 14, 2019 |
Est. primary completion date | March 14, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in functional exercise capacity | Functional exercise capacity is measured by a 6-minute walk test | Assessments one day before surgery, 1 and 3 months postoperative | |
Secondary | Change in muscle fatigability | Muscle fatigability is measured using a Cybex dynamometer | Assessments one day before surgery, 1 and 3 months postoperative | |
Secondary | Change in flexibility | Flexibility is measured by Toe touch test | Assessments one day before surgery, 1 and 3 months postoperative | |
Secondary | Change in flexibility | Flexibility is measured by sit and reach test | Assessments one day before surgery, 1 and 3 months postoperative | |
Secondary | Change in upper body strength and endurance | Upper body strength and endurance are measured by the 30-second arm curl test | Assessments one day before surgery, 1 and 3 months postoperative | |
Secondary | Change in hand grip strength | Hand grip strength test is performed using a JamarĀ® dynamometer | Assessments one day before surgery, 1 and 3 months postoperative | |
Secondary | Change in health-related quality of life | Health-related quality of life is evaluated with the version 4 of the University of Washington head and neck cancer questionnaire | Assessments one day before surgery, 1 and 3 months postoperative | |
Secondary | Change in common symptom batteries in cancer patients | Common symptom batteries is measured by the Edmonton Symptom Assessment System (revised version) questionnaire | Assessments one day before surgery, 1 and 3 months postoperative | |
Secondary | Change in nutritional status | Nutritional status is measured with the Short Nutritional Assessment Questionnaire | Assessments one day before surgery, 1 and 3 months postoperative | |
Secondary | Change in blood pressure | Resting blood pressure is measured using the M6 Comfort automatic blood pressure monitor | Assessments one day before surgery, 1 and 3 months postoperative | |
Secondary | Change in weight | Weight (kg) is measured by using a bioelectrical impedance analysis | Assessments one day before surgery, 1 and 3 months postoperative | |
Secondary | Change in fat body mass | Fat body mass (%) is measured by using a bioelectrical impedance analysis | Assessments one day before surgery, 1 and 3 months postoperative | |
Secondary | Change in waist circumference | Waist circumference is measured with a non-elastic tape measure | Assessments one day before surgery, 1 and 3 months postoperative |
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