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NCT Number: NCT04022044

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational group

Behavioral

Primary outcomes

  1. 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

  1. Change in muscle fatigability

    Time frame: Assessments one day before surgery, 1 and 3 months postoperative

    Muscle fatigability is measured using a Cybex dynamometer

  2. Change in flexibility

    Time frame: Assessments one day before surgery, 1 and 3 months postoperative

    Flexibility is measured by Toe touch test

  3. Change in flexibility

    Time frame: Assessments one day before surgery, 1 and 3 months postoperative

    Flexibility is measured by sit and reach test

  4. Change in upper body strength and endurance

    Time frame: Assessments one day before surgery, 1 and 3 months postoperative

    Upper body strength and endurance are measured by the 30-second arm curl test

  5. Change in hand grip strength

    Time frame: Assessments one day before surgery, 1 and 3 months postoperative

    Hand grip strength test is performed using a Jamar® dynamometer

  6. Change in health-related quality of life

    Time frame: Assessments one day before surgery, 1 and 3 months postoperative

    Health-related quality of life is evaluated with the version 4 of the University of Washington head and neck cancer questionnaire

  7. Change in common symptom batteries in cancer patients

    Time frame: Assessments one day before surgery, 1 and 3 months postoperative

    Common symptom batteries is measured by the Edmonton Symptom Assessment System (revised version) questionnaire

  8. Change in nutritional status

    Time frame: Assessments one day before surgery, 1 and 3 months postoperative

    Nutritional status is measured with the Short Nutritional Assessment Questionnaire

  9. Change in blood pressure

    Time frame: Assessments one day before surgery, 1 and 3 months postoperative

    Resting blood pressure is measured using the M6 Comfort automatic blood pressure monitor

  10. Change in weight

    Time frame: Assessments one day before surgery, 1 and 3 months postoperative

    Weight (kg) is measured by using a bioelectrical impedance analysis

  11. Change in fat body mass

    Time frame: Assessments one day before surgery, 1 and 3 months postoperative

    Fat body mass (%) is measured by using a bioelectrical impedance analysis

  12. Change in waist circumference

    Time frame: Assessments one day before surgery, 1 and 3 months postoperative

    Waist circumference is measured with a non-elastic tape measure

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 16, 2019
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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