Head and Neck CancerNCT00751816
Head & Neck Cancer Survivorship: Physical and Functional Status
An observational study of Head and Neck Cancer, run by Vanderbilt University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- systemic chemotherapy, survey administration and adjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2008to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Head and Neck Cancer Patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- systemic chemotherapy, survey administration, adjuvant therapy, management of therapy complications, musculoskeletal complications management/prevention
- Keywords
- 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
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esthesioneuroblastoma, Olfactory, Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systemic chemotherapyDrug
Also called none noted
survey administrationOther
Also called 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 therapyProcedure or surgery
Also called none noted
management of therapy complicationsProcedure or surgery
Also called None noted
musculoskeletal complications management/preventionProcedure or surgery
Also called none noted
physical therapyProcedure or surgery
Also called none noted
weekly visits coordinated with adjuvant treatment as part of standard care
radiation therapyRadiation
Also called none noted
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care | head and neck cancer survivors who are undergoing chemotherapy and radiation therapy Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical and functional well-being during adjuvant chemoradiotherapy
Measured: 2 weeks after completing treatment
Range of motion for the cervical spine and shoulder during adjuvant chemoradiotherapy
Measured: 2 weeks after completing treatment
Feasibility of an early physical therapy intervention
Measured: 2 weeks after completing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ann Marie Flores, Ph.D., Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751816
- Sponsor's protocol ID
- CDR0000613863
- Other IDs
- VU-VICC-SUPP-0843
- Status last verified
- Dec 2015
- First submitted
- 11 Sep 2008
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head & Neck Cancer Survivorship: Physical and Functional Status
- ClinicalTrials.gov ID
- NCT00751816
- Acronym / sponsor ID
- CDR0000613863
- Conditions
- Head and Neck Cancer
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 12 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care | – | Drug: systemic chemotherapy, Other: survey administration, Procedure: adjuvant therapy, Procedure: management of therapy complications, Procedure: musculoskeletal complications management/prevention, Procedure: physical therapy, Radiation: radiation therapyhead and neck cancer survivors who are undergoing chemotherapy and radiation therapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Head and Neck Cancer Patients
Key inclusion criteria (5 listed)
- Head and neck cancer survivor
- Planning to receive adjuvant chemoradiotherapy for head and neck cancer
- Referred to rehabilitation oncology physical therapy program
Key exclusion criteria (8 listed)
- No metastatic disease
- No CNS cancer
- Speaks English
- No significant history of cardiovascular or neurovascular disease involving disability
- See Disease Characteristics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| systemic chemotherapyAlso: none noted | Drug | Supportive Care |
| survey administrationAlso: none notedwill be administered before, during, and after medical intent-to-cure treatment to describe head and neck cancer survivors' physical and functional well-being. | Other | Supportive Care |
| adjuvant therapyAlso: none noted | Procedure or surgery | Supportive Care |
| management of therapy complicationsAlso: None noted | Procedure or surgery | Supportive Care |
| musculoskeletal complications management/preventionAlso: none noted | Procedure or surgery | Supportive Care |
| physical therapyAlso: none notedweekly visits coordinated with adjuvant treatment as part of standard care | Procedure or surgery | Supportive Care |
| radiation therapyAlso: none noted | Radiation | Supportive Care |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Marie Flores, Ph.D. study chair
Vanderbilt-Ingram Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Vanderbilt University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical and functional well-being during adjuvant chemoradiotherapy (time frame: 2 weeks after completing treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.