Head and Neck CancerNCT04276454
Lymphedema Treatment in Head and Neck Cancer Patients
A study testing Flexitouch Plus system in people with Head and Neck Cancer, run by Endeavor Health at 1 site in United States.
Trial summary
The purpose of this research is to evaluate the result of treatment for neck lymphedema on throat pressure in patients who have received radiation therapy for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Flexitouch Plus system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2020to 23 Apr 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with tumors of the nasopharynx, oral cavity, oropharynx, hypopharynx, or larynx who will have radiation therapy as part of their treatment plan
- Both male and females
- 18 to 100 years of age
Who cannot join
- Significant surgical resection of pharyngeal constrictor muscles
- Patients with persistent or recurrent disease
- Patients who have contraindications to use Flexitouch Plus device
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Chicago, Illinois, 60201
About this study
Official title: Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients
The purpose of this research is to evaluate the result of treatment for neck lymphedema on throat pressure in patients who have received radiation therapy for head and neck cancer.
Read the detailed description
Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. The lymphedema seen in patients treated for head and neck cancer can be seen externally on the neck and face, as well as internally in the lining of the throat. In this study, the investigators plan to treat the external lymphedema with a device called the Flexitouch Plus, which is already approved by the Food and Drug Administration (FDA) for lymphedema treatment, and to measure the degree of internal lymphedema using a pressure sensor to detect throat muscle pressure before and after the treatment with the Flexitouch Plus device.
- Conditions
- Head and Neck Cancer
- Being tested
- Flexitouch Plus system
- Keywords
- Head and Neck Cancer, Lymphedema, Treatment
- Medical subject headings
- Head and Neck Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexitouch Plus systemDevice
A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Device: Flexitouch Plus system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal lymphedema measurement
The pressure in the throat will be measured using a device called high-resolution manometry before and after wearing a treatment jacket (Flexitouch plus device).
Measured: 2 hours
Secondary outcomes (1)
External lymphedema measurement
Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device).
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start23 Apr 2020
- Primary completion23 Apr 2020
- Study completion23 Apr 2020
Why it stopped: Per investigator's request.
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will receive a single intervention.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- Tactile Medical
- Responsible party
- Sponsor
- Investigators
- Mihir Bhayani, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276454
- Sponsor's protocol ID
- EH19-199
- Status last verified
- Aug 2020
- First submitted
- 17 Feb 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT04276454
- Acronym / sponsor ID
- EH19-199
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Lymphedema, Treatment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Per investigator's request.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- Tactile Medical
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 23 Apr 2020 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 19 Feb 2020 (actual)
- 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.
The purpose of this research is to evaluate the result of treatment for neck lymphedema on throat pressure in patients who have received radiation therapy for head and neck cancer.
Detailed description
Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. The lymphedema seen in patients treated for head and neck cancer can be seen externally on the neck and face, as well as internally in the lining of the throat. In this study, the investigators plan to treat the external lymphedema with a device called the Flexitouch Plus, which is already approved by the Food and Drug Administration (FDA) for lymphedema treatment, and to measure the degree of internal lymphedema using a pressure sensor to detect throat muscle pressure before and after the treatment with the Flexitouch Plus device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will receive a single intervention.
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: Flexitouch Plus system |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with tumors of the nasopharynx, oral cavity, oropharynx, hypopharynx, or larynx who will have radiation therapy as part of their treatment plan
- Both male and females
- 18 to 100 years of age
Key exclusion criteria (3 listed)
- Significant surgical resection of pharyngeal constrictor muscles
- Patients with persistent or recurrent disease
- Patients who have contraindications to use Flexitouch Plus device
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 |
|---|---|---|
| Flexitouch Plus systemA single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. | Device | Single arm |
Primary outcome
Internal lymphedema measurement
Time frame: 2 hours
The pressure in the throat will be measured using a device called high-resolution manometry before and after wearing a treatment jacket (Flexitouch plus device).
1 secondary outcome
External lymphedema measurement
Time frame: 2 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Mihir Bhayani, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexitouch Plus system in people with Head and Neck Cancer, run by Endeavor Health 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 13 Aug 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Internal lymphedema measurement (time frame: 2 hours). 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 13 Aug 2020.