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Head & Neck Cancer Survivorship: Physical and Functional Status

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00751816
First received: September 11, 2008
Last updated: January 3, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
 Drug: systemic chemotherapy
Other: survey administration
Procedure: adjuvant therapy
Procedure: management of therapy complications
Procedure: musculoskeletal complications management/prevention
Procedure: physical therapy
Radiation: radiation therapy
 Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Head & Neck Cancer Survivorship: Physical and Functional Status

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Physical and functional well-being during adjuvant chemoradiotherapy [ Time Frame: 2 weeks after completing treatment ] [ Designated as safety issue: No ]
  • Range of motion for the cervical spine and shoulder during adjuvant chemoradiotherapy [ Time Frame: 2 weeks after completing treatment ] [ Designated as safety issue: No ]
  • Feasibility of an early physical therapy intervention [ Time Frame: 2 weeks after completing treatment ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: June 2008
Estimated Study Completion Date: June 2014
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Supportive Care Drug: systemic chemotherapy
Not specified
Other Name: none noted
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.
Other Name: none noted
Procedure: adjuvant therapy
not specified
Other Name: none noted
Procedure: management of therapy complications
not specified
Other Name: None noted
Procedure: musculoskeletal complications management/prevention
Not specified
Other Name: none noted
Procedure: physical therapy
weekly visits coordinated with adjuvant treatment as part of standard care
Other Name: none noted
Radiation: radiation therapy
not specified
Other Name: none noted

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Head and Neck Cancer Patients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751816

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
Study Chair: Ann Marie Flores, Ph.D. Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Ann Marie Flores, Ph.D., Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00751816     History of Changes
Other Study ID Numbers: CDR0000613863, VU-VICC-SUPP-0843
Study First Received: September 11, 2008
Last Updated: January 3, 2011
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
salivary gland acinic cell tumor
musculoskeletal complications
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the larynx
stage I verrucous carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage II verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
stage I adenoid cystic carcinoma of the oral cavity
 stage I mucoepidermoid carcinoma of the oral cavity
stage I verrucous carcinoma of the oral cavity
stage II adenoid cystic carcinoma of the oral cavity
stage II mucoepidermoid carcinoma of the oral cavity
stage II verrucous carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage III verrucous carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV verrucous carcinoma of the oral cavity
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Adjuvants, Immunologic
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013