Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments systemic chemotherapy, survey administration, adjuvant therapy, management of therapy complications, musculoskeletal complications management/prevention, physical therapy, radiation therapy
Phase phase 1
Sponsor Vanderbilt University
Collaborator National Cancer Institute (NCI)
Start date June 2008
End date February 2009
Trial size 23 participants
Trial identifier NCT00751816, CDR0000613863, VU-VICC-SUPP-0843

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
systemic chemotherapy none noted
Not specified
survey administration none noted
will be administered before, during, and after medical intent-to-cure treatment to describe head and neck cancer survivors' physical and functional well-being.
adjuvant therapy none noted
not specified
management of therapy complications None noted
not specified
musculoskeletal complications management/prevention none noted
Not specified
physical therapy none noted
weekly visits coordinated with adjuvant treatment as part of standard care
radiation therapy none noted
not specified

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Head & Neck Cancer Survivorship: Physical and Functional Status
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by Vanderbilt University.