NCT00248235

Brief Summary

The purpose of this study is to investigate the effect of a progressive therapeutic exercise program on specific physical and functional deficits in the neck and shoulder region occurring as a result of head and neck cancer treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

September 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

2.7 years

First QC Date

November 1, 2005

Last Update Submit

November 4, 2024

Conditions

Head and Neck Neoplasms

Keywords

exerciserehabilitationhead and neck neoplasms

Outcome Measures

Primary Outcomes (4)

  • Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months)

    baseline, 12 weeks, 6 months, 12 months

  • Active and passive range of motion (baseline, 12 weeks)

    baseline, 12 weeks

  • Muscular strength and endurance (baseline, 12 weeks)

    baseline, 12 weeks

  • Quality of life (baseline, 12 weeks, 6 months, 12 months)

    baseline, 12 weeks, 6 months, 12 months

Secondary Outcomes (3)

  • Anxiety, depression and fatigue (baseline, 12 weeks, 6 months, 12 months)

    baseline, 12 weeks, 6 months, 12 months

  • Nerve conduction testing (baseline, 12 weeks as indicated)

    Baseline

  • Electromyography (baseline, 12 weeks as indicated)

    Baseline

Study Arms (2)

PRET

EXPERIMENTAL

Progressive Resistance Exercise Training: upper extremity 6-8 exercises

Behavioral: Exercise

Standard Care

ACTIVE COMPARATOR

Standard Care: physical therapy - range of motion, 6-8 strengthening exercises

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL
PRETStandard Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx OR squamous cell carcinoma metastatic to the neck from unknown primary site; probable occult mucosal origin in the head and neck
  • Surgical treatment includes radical neck dissection, modified radical neck dissection and other variants of functional/selective neck dissection
  • Karnofsky Performance Status greater than or equal to 60%
  • No evidence of residual cancer in the neck and no distant (M0) metastasis
  • Participants must have completed their head and neck cancer treatment

You may not qualify if:

  • A history of shoulder or neck pathology unrelated to cancer treatment
  • Serious co-morbid medical illness or psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioral Medicine Laboratory, University of Alberta

Edmonton, Alberta, T6G 2H9, Canada

Location

Related Publications (1)

  • McNeely ML, Parliament M, Courneya KS, Seikaly H, Jha N, Scrimger R, Hanson J. A pilot study of a randomized controlled trial to evaluate the effects of progressive resistance exercise training on shoulder dysfunction caused by spinal accessory neurapraxia/neurectomy in head and neck cancer survivors. Head Neck. 2004 Jun;26(6):518-30. doi: 10.1002/hed.20010.

    PMID: 15162353BACKGROUND

MeSH Terms

Conditions

Head and Neck NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kerry S Courneya, PhD

    Professor, Faculty of Physical Education and Recreation, University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2005

First Posted

November 3, 2005

Study Start

September 1, 2005

Primary Completion

May 1, 2008

Study Completion

January 1, 2009

Last Updated

November 5, 2024

Record last verified: 2024-11

Locations

CA(1)