Postoperative Changes in Head and Neck Cancer Patients Undergoing Surgery

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 Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Behavioral: Observational group

• Study Type: Observational
• Enrollment (Actual): 24

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults with head and neck cancer planned for an elective major surgery

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in muscle fatigability	Muscle fatigability is measured using a Cybex dynamometer	Assessments one day before surgery, 1 and 3 months postoperative
Change in flexibility	Flexibility is measured by Toe touch test	Assessments one day before surgery, 1 and 3 months postoperative
Change in flexibility	Flexibility is measured by sit and reach test	Assessments one day before surgery, 1 and 3 months postoperative
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
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
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
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
Change in nutritional status	Nutritional status is measured with the Short Nutritional Assessment Questionnaire	Assessments one day before surgery, 1 and 3 months postoperative
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
Change in weight	Weight (kg) is measured by using a bioelectrical impedance analysis	Assessments one day before surgery, 1 and 3 months postoperative
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
Change in waist circumference	Waist circumference is measured with a non-elastic tape measure	Assessments one day before surgery, 1 and 3 months postoperative

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2014
• Primary Completion (Actual): March 14, 2019
• Study Completion (Actual): June 14, 2019

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: Postoperative changes H&N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No