NCT04022044

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

4.2 years

First QC Date

July 10, 2019

Last Update Submit

July 15, 2019

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • 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 flexibility

    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 hand grip strength

    Assessments one day before surgery, 1 and 3 months postoperative

  • +7 more secondary outcomes

Interventions

Observational groupBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • \- Neurological or orthopedic impairments not suitable for testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 16, 2019

Study Start

December 30, 2014

Primary Completion

March 14, 2019

Study Completion

June 14, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07