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Clinical Trials/NCT00751816
NCT00751816CompletedNot Applicable

Head & Neck Cancer Survivorship: Physical and Functional Status

Vanderbilt University3 sites in 1 country23 target enrollmentStarted: June 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
23
Locations
3
Primary Endpoint
Physical and functional well-being during adjuvant chemoradiotherapy

Study Overview

Brief Summary

RATIONALE: Early physical therapy may be effective in improving range of motion of the neck and shoulders in head and neck cancer survivors who are undergoing chemotherapy and radiation therapy.

PURPOSE: This phase I trial is studying how well early physical therapy works in improving physical and functional well-being in head and neck cancer survivors receiving chemoradiotherapy.

Detailed Description

OBJECTIVES:

  • Describe the physical and functional well-being of head and neck cancer (HNC) survivors undergoing physical therapy during adjuvant chemoradiotherapy.
  • Describe clinical measure of range of motion for the cervical spine and shoulder of HNC survivors undergoing physical therapy during adjuvant chemoradiotherapy.
  • Determine the feasibility of an early physical therapy intervention (prior to and during adjuvant treatment) targeting the physical needs of HNC survivors.

OUTLINE: Patients undergo physical therapy weekly for 10 weeks beginning 1 week prior to initiating adjuvant chemoradiotherapy and continuing until 2 weeks after the completion of adjuvant chemoradiotherapy.

Patients undergo range of motion assessment and complete a Cancer Survivorship Survey (CSS) at baseline and in weeks 4, 8, 9, and 10 of physical therapy.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • DISEASE CHARACTERISTICS:
  • Head and neck cancer survivor
  • Planning to receive adjuvant chemoradiotherapy for head and neck cancer
  • Has not yet initiated adjuvant therapy
  • Referred to rehabilitation oncology physical therapy program

Exclusion Criteria

  • No metastatic disease
  • No CNS cancer
  • PATIENT CHARACTERISTICS:
  • Speaks English
  • No significant history of cardiovascular or neurovascular disease involving disability
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Not currently in hospice care

Arms & Interventions

Supportive Care

head and neck cancer survivors who are undergoing chemotherapy and radiation therapy

Intervention: systemic chemotherapy (Drug)

Supportive Care

head and neck cancer survivors who are undergoing chemotherapy and radiation therapy

Intervention: survey administration (Other)

Supportive Care

head and neck cancer survivors who are undergoing chemotherapy and radiation therapy

Intervention: adjuvant therapy (Procedure)

Supportive Care

head and neck cancer survivors who are undergoing chemotherapy and radiation therapy

Intervention: management of therapy complications (Procedure)

Supportive Care

head and neck cancer survivors who are undergoing chemotherapy and radiation therapy

Intervention: musculoskeletal complications management/prevention (Procedure)

Supportive Care

head and neck cancer survivors who are undergoing chemotherapy and radiation therapy

Intervention: physical therapy (Procedure)

Supportive Care

head and neck cancer survivors who are undergoing chemotherapy and radiation therapy

Intervention: radiation therapy (Radiation)

Outcomes

Primary Outcomes

Physical and functional well-being during adjuvant chemoradiotherapy

Time Frame: 2 weeks after completing treatment

Range of motion for the cervical spine and shoulder during adjuvant chemoradiotherapy

Time Frame: 2 weeks after completing treatment

Feasibility of an early physical therapy intervention

Time Frame: 2 weeks after completing treatment

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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