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NCT04022044 Clinical Trial

Postoperative Changes in Head and Neck Cancer Patients Undergoing Surgery

Head and Neck Cancer Clinical Trial

Official title:
Postoperative Changes in Head and Neck Cancer Patients Undergoing Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04022044
Other study ID # Postoperative changes H&N
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 30, 2014
Est. completion date June 14, 2019

Study information
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

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Observational group

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Outcome
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 Jamar® 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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