Oral Cavity CancerNCT02412241
Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients
A study testing LEF measures and Technical measure in people with Oral Cavity Cancer and Oropharyngeal Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
This four-year, prospective, longitudinal study will evaluate and validate a patient-reported outcome measure, clinician-reported outcome measures, and imaging techniques in assessing characteristics, trajectory, and progression of lymphedema and fibrosis (LEF) in oral cavity and oropharyngeal cancer patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Oral Cavity Cancer, Oropharyngeal Cancer, Lymphedema
- What is being tested?
- LEF measures and Technical measure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Aug 2020
- Phase
- Interventional
- 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
Who may be able to join
- a newly diagnosed, histologically proven cancer arising from the oral cavity and oropharynx
- tumor stage II or greater
- age ≥ 21 years old
- willing and able to undergo study assessment
- able to speak and read English and understand Informed Consent.
Who cannot join
- have medical record documentation of cognitive impairment that would preclude the ability to provide informed consent
- are unwilling to undergo routine follow-up
- have recurrent cancer
- have any other active cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
This four-year, prospective, longitudinal study will evaluate and validate a patient-reported outcome measure, clinician-reported outcome measures, and imaging techniques in assessing characteristics, trajectory, and progression of lymphedema and fibrosis (LEF) in oral cavity and oropharyngeal cancer patients.
This clinical trial studies patient-and-clinician-reported measures as well as standard imaging methods to see how accurate they are in identifying and evaluating lymphedema (swelling) or fibrosis (tough or tight tissue) in the head and neck region of patients receiving treatment for newly diagnosed stage II-IV oral cavity or oropharyngeal cancer. Lymphedema and fibrosis (LEF) can lead to physical symptoms, such as trouble swallowing and chewing, as well as psychological and emotional symptoms, such as negative body image and avoiding social interactions. Finding an accurate test to identify and evaluate LEF may allow doctors to treat LEF more quickly and control symptoms more effectively, and thus provide patients with a better quality of life.
Read the detailed description
The goal of this proposed study is to establish a valid, clinically useful measurement battery for head and neck LEF by achieving these specific aims:
Aim 1: To determine the reliability and validity of the patient-reported outcome measure (LSIDS-H\&N) for assessing LEF-related symptoms in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival.
Aim 2: To determine the reliability and validity of the clinician-reported outcome measures (HN-LEF Grading Criteria and Modified Patterson Scale) for assessing external and internal LEF in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival.
Aim 3: To determine the reliability and validity of imaging techniques (CT scan and ultrasonography) in identifying site-specific LEF in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival.
- Conditions
- Oral Cavity Cancer, Oropharyngeal Cancer, Lymphedema, Fibrosis
- Being tested
- LEF measures, Technical measure
- Medical subject headings
- Mouth Neoplasms, Oropharyngeal Neoplasms, Lymphedema, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEF measuresOther
Patient-reported outcome measure; clinician-reported outcome measures
Technical measureProcedure or surgery
Also called Computed Tomography (CT)
Undergo standard CT scan
Technical measureProcedure or surgery
Also called Ultrasonography, Ultrasound (US) Medical Ultrasound
Undergo standard ultrasound
| Study group | Role | What they receive |
|---|---|---|
| LEF Measures | Other | PATIENT-REPORTED OUTCOME MEASURE: Validity of LSIDS-H\&N will be assessed using 6 forms (e.g., Vanderbilt Head and Neck Symptom Survey (v2.0); Neck Disability Index; and Hospital Anxiety and Depression Scale).
CLINICIAN-REPORTED OUTCOME MEASURES: External LEF will be assessed using HN-LEF Grading Criteria, CTCAE (v4.03), and digital photos of the head and neck. Internal LEF will be scored using Modified Patterson Scale through an endoscopic exam. Both external/internal measures are re-assessed for intrarater and interrater reliability.
OBJECTIVE/TECHNICAL MEASURES: Patients undergo CT scans and ultrasound exams with results re-scored for intrarater and interrater reliability. Receives: Other: LEF measures; Procedure: Technical measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of the patient-reported outcome measure (LSIDS-H&N) in terms of internal consistency of each symptom cluster
The assessment will be conducted at pre-treatment, end of treatment (EOT), and every three months up to 12 months after treatment
Measured: Up to 12 months after treatment
Secondary outcomes (5)
Validity of the patient-reported outcome measure (LSIDS-H&N) in terms of content, construct, sensitivity to change, and clinical feasibility
The assessment will be conducted at pre-treatment, EOT, and every three months up to 12 months after treatment
Measured: Up to 12 months after treatment
Reliability of the clinician-reported outcome measures (HN-LEF Grading criteria and the Modified Patterson Scale)
The assessment will be conducted at pre-treatment, EOT, and every three months up to 12 months after treatment
Measured: 12 months after treatment
Validity of the clinician-reported outcome measures (HN-LEF Grading criteria and the Modified Patterson Scale) in terms of criteria correlations, sensitivity to change, and clinical feasibility
The assessment will be conducted at pre-treatment, EOT, and every three months up to 12 months after treatment
Measured: 12 months after treatment
Reliability of imaging techniques in identifying site-specific LEF across the trajectory of treatment, recovery, and survival
The assessment will be conducted at pre-treatment, and every three months up to 12 months after treatment
Measured: 12 months after treatment
Validity of imaging techniques in identifying site-specific LEF across the trajectory of treatment, recovery, and survival, in terms of concordance correlation, sensitivity to change, and clinical feasibility
The assessment will be conducted at pre-treatment, and every three months up to 12 months after treatment
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Cavity 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Jie Deng, Vanderbilt-Ingram Cancer Center
- Investigators
- Jie Deng, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412241
- Sponsor's protocol ID
- VICC SUPP 1529
- Other IDs
- 1R01DE024982-01
- Status last verified
- Mar 2021
- First submitted
- 3 Apr 2015
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients
- ClinicalTrials.gov ID
- NCT02412241
- Acronym / sponsor ID
- VICC SUPP 1529
- Conditions
- Oral Cavity Cancer, Oropharyngeal Cancer, Lymphedema, Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Jun 2015
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 9 Apr 2015 (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.
This four-year, prospective, longitudinal study will evaluate and validate a patient-reported outcome measure, clinician-reported outcome measures, and imaging techniques in assessing characteristics, trajectory, and progression of lymphedema and fibrosis (LEF) in oral cavity and oropharyngeal cancer patients.
This clinical trial studies patient-and-clinician-reported measures as well as standard imaging methods to see how accurate they are in identifying and evaluating lymphedema (swelling) or fibrosis (tough or tight tissue) in the head and neck region of patients receiving treatment for newly diagnosed stage II-IV oral cavity or oropharyngeal cancer. Lymphedema and fibrosis (LEF) can lead to physical symptoms, such as trouble swallowing and chewing, as well as psychological and emotional symptoms, such as negative body image and avoiding social interactions. Finding an accurate test to identify and evaluate LEF may allow doctors to treat LEF more quickly and control symptoms more effectively, and thus provide patients with a better quality of life.
Detailed description
The goal of this proposed study is to establish a valid, clinically useful measurement battery for head and neck LEF by achieving these specific aims:
Aim 1: To determine the reliability and validity of the patient-reported outcome measure (LSIDS-H\&N) for assessing LEF-related symptoms in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival.
Aim 2: To determine the reliability and validity of the clinician-reported outcome measures (HN-LEF Grading Criteria and Modified Patterson Scale) for assessing external and internal LEF in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival.
Aim 3: To determine the reliability and validity of imaging techniques (CT scan and ultrasonography) in identifying site-specific LEF in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEF Measures | Other | Other: LEF measures, Procedure: Technical measurePATIENT-REPORTED OUTCOME MEASURE: Validity of LSIDS-H\&N will be assessed using 6 forms (e.g., Vanderbilt Head and Neck Symptom Survey (v2.0); Neck Disability Index; and Hospital Anxiety and Depression Scale). CLINICIAN-REPORTED OUTCOME MEASURES: External LEF will be assessed using HN-LEF Grading Criteria, CTCAE (v4.03), and digital photos of the head and neck. Internal LEF will be scored using Modified Patterson Scale through an endoscopic exam. Both external/internal measures are re-assessed for intrarater and interrater reliability. OBJECTIVE/TECHNICAL MEASURES: Patients undergo CT scans and ultrasound exams with results re-scored for intrarater and interrater reliability. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a newly diagnosed, histologically proven cancer arising from the oral cavity and oropharynx
- tumor stage II or greater
- age ≥ 21 years old
- willing and able to undergo study assessment
- able to speak and read English and understand Informed Consent.
Key exclusion criteria (4 listed)
- have medical record documentation of cognitive impairment that would preclude the ability to provide informed consent
- are unwilling to undergo routine follow-up
- have recurrent cancer
- have any other active cancer.
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 |
|---|---|---|
| LEF measuresPatient-reported outcome measure; clinician-reported outcome measures | Other | LEF Measures |
| Technical measureAlso: Computed Tomography (CT)Undergo standard CT scan | Procedure or surgery | LEF Measures |
| Technical measureAlso: Ultrasonography, Ultrasound (US) Medical UltrasoundUndergo standard ultrasound | Procedure or surgery | LEF Measures |
Primary outcome
Reliability of the patient-reported outcome measure (LSIDS-H&N) in terms of internal consistency of each symptom cluster
Time frame: Up to 12 months after treatment
The assessment will be conducted at pre-treatment, end of treatment (EOT), and every three months up to 12 months after treatment
5 secondary outcomes
Validity of the patient-reported outcome measure (LSIDS-H&N) in terms of content, construct, sensitivity to change, and clinical feasibility
Time frame: Up to 12 months after treatment
Reliability of the clinician-reported outcome measures (HN-LEF Grading criteria and the Modified Patterson Scale)
Time frame: 12 months after treatment
Validity of the clinician-reported outcome measures (HN-LEF Grading criteria and the Modified Patterson Scale) in terms of criteria correlations, sensitivity to change, and clinical feasibility
Time frame: 12 months after treatment
Reliability of imaging techniques in identifying site-specific LEF across the trajectory of treatment, recovery, and survival
Time frame: 12 months after treatment
Validity of imaging techniques in identifying site-specific LEF across the trajectory of treatment, recovery, and survival, in terms of concordance correlation, sensitivity to change, and clinical feasibility
Time frame: 12 months after 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 3 Mar 2021.
- Vanderbilt Ingram Cancer Center, Find a Clinical TrialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Oral Cavity Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
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.
Jie Deng principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LEF measures and Technical measure in people with Oral Cavity Cancer and Oropharyngeal Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site 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 4 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 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Reliability of the patient-reported outcome measure (LSIDS-H&N) in terms of internal consistency of each symptom cluster (time frame: Up to 12 months after treatment). 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 3 Mar 2021.