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OpenTrials
Completed

NCT Number: NCT00751816

Head & Neck Cancer Survivorship: Physical and Functional Status

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

systemic chemotherapy

Drug

Other names: none noted

Survey Administration

Other

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 names: none noted

adjuvant therapy

Procedure

Other names: none noted

management of therapy complications

Procedure

Other names: None noted

musculoskeletal complications management/prevention

Procedure

Other names: none noted

physical therapy

Procedure

weekly visits coordinated with adjuvant treatment as part of standard care

Other names: none noted

radiation therapy

Radiation

Other names: none noted

Primary outcomes

  1. Physical and functional well-being during adjuvant chemoradiotherapy

    Time frame: 2 weeks after completing treatment

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

    Time frame: 2 weeks after completing treatment

  3. Feasibility of an early physical therapy intervention

    Time frame: 2 weeks after completing treatment

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 12, 2008
Registry last updated
Dec 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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