Head & Neck Cancer Survivorship: Physical and Functional Status

Head and Neck Cancer Clinical Trial

Official title:

Head & Neck Cancer Survivorship: Physical and Functional Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751816
• Other study ID #: CDR0000613863
• Secondary ID: VU-VICC-SUPP-084
• Status: Completed
• Phase: Phase 1
• First received: September 11, 2008
• Last updated: December 8, 2015
• Start date: June 2008
• Est. completion date: January 2009

Study information

• Verified date: December 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• systemic chemotherapy
Not specified

Other:
• survey administration
will be administered before, during, and after medical intent-to-cure treatment to describe head and neck cancer survivors' physical and functional well-being.

Procedure:
• adjuvant therapy
not specified
• management of therapy complications
not specified
• musculoskeletal complications management/prevention
Not specified
• physical therapy
weekly visits coordinated with adjuvant treatment as part of standard care

Radiation:
• radiation therapy
not specified

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical and functional well-being during adjuvant chemoradiotherapy		2 weeks after completing treatment	No
Primary	Range of motion for the cervical spine and shoulder during adjuvant chemoradiotherapy		2 weeks after completing treatment	No
Primary	Feasibility of an early physical therapy intervention		2 weeks after completing treatment	No