Breast Cancer Related LymphedemaNCT04073823
A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients
A study testing Flexitouch Plus and Flexitouch Plus FT with software modification in people with Breast Cancer Related Lymphedema, run by Tactile Medical at 1 site in United States.
Trial summary
The objective of the study is to demonstrate equivalency in treatment effect, as determined by objective measurements, between the modified therapy cycle software and the FDA-cleared Flexitouch therapy cycle software. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Related Lymphedema
- What is being tested?
- Flexitouch Plus and Flexitouch Plus FT with software modification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2020to 8 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female 18 years of age or older
- Diagnosis of unilateral breast cancer-related lymphedema
- Stage I or early stage II lymphedema without severe fibrosis at the time of enrollment
- ≥ 5% volume difference between affected and unaffected arm as verified via perometry
- Willing and able to give informed consent
- Willing and able to comply with the study protocol requirements and all study-related visit requirements
Who cannot join
- In-home use of PCD within previous 3 months
- Therapist or self-administered manual lymph drainage (MLD) within previous 1 week
- Mastectomy or lymph node removal on side without lymphedema
- Bilateral lymphedema
- Heart failure (acute pulmonary edema, decompensated acute heart failure)
- Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
Show all 13Show fewer
- Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk
- Active cancer (cancer that is currently under treatment, but not yet in remission)
- Poorly controlled kidney disease (glomerular filtration rate < 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or Munchausen Syndrome
- BMI >50
- Any circumstance where increased lymphatic or venous return is undesirable
- Currently pregnant or trying to become pregnant
- Allergy to iodine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: A Feasibility Study Evaluating Flexitouch® Plus With a Therapy Cycle Software Modification in Patients With Unilateral Breast Cancer-Related Lymphedema (BCRL)
The objective of the study is to demonstrate equivalency in treatment effect, as determined by objective measurements, between the modified therapy cycle software and the FDA-cleared Flexitouch therapy cycle software.
- Conditions
- Breast Cancer Related Lymphedema
- Being tested
- Flexitouch Plus, Flexitouch Plus FT with software modification
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexitouch PlusDevice
Flexitouch Plus full arm and core treatment
Flexitouch Plus FT with software modificationDevice
Also called FT-SW
Flexitouch Plus full arm and trunk/chest treatment
| Study group | Role | What they receive |
|---|---|---|
| Flexitouch Plus | Active comparator | Not described Receives: Device: Flexitouch Plus |
| Flexitouch Plus with SW | Experimental | Not described Receives: Device: Flexitouch Plus FT with software modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphatic Activation
Comparison of the change in the rate of lymphatic propulsion events from the pre-treatment values to the post-treatment values for both the affected and contralateral limbs using the investigational technique of near infrared-fluorescent (NIRF) imaging.
Measured: Baseline and following a single treatment, an average of one hour
Changes in Swelling - MoistureMeterD
Comparison of the percent change in local tissue water from the pre-treatment values to the post-treatment values on the affected limb using MoistureMeterD.
Measured: Baseline and following a single treatment, an average of one hour
Changes in Swelling - Perometry
Swelling in the affected and contralateral limb as assessed using local tissue water content
Measured: Baseline and following a single treatment, an average of one hour
Percent Change in Skin Thickness From Baseline to After Treatment.
Skin changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
Measured: Baseline and following a single treatment, an average of one hour
Incidence of Adverse Events
Adverse events reported between treatment and the 24-hour follow-up
Measured: 24-Hour Follow-Up
Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging
Comparison of the number of subjects with an increase in vessels for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging.
Measured: Baseline and following a single treatment, an average of one hour
Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging
Comparison of the change in dermal backflow from the pre-treatment values to the post-treatment values as the sum of the volume of area for all locations for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging
Measured: Baseline and following a single treatment, an average of one hour
Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner)
Compare the percent of participants by arm demonstrating a decrease in limb volume for the affected and contralateral limbs via Perometry (LymphaTech 3D Scanner)
Measured: Baseline and following a single treatment, an average of one hour
Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound)
Comparison of the percent of participants by arm demonstrating a decrease in thickness for each site, separating skin and subcutaneous changes, on the affected limb via Ultrasound
Measured: Baseline and following a single treatment, an average of one hour
Absolute Change in Skin Thickness From Baseline to After Treatment
Skin Changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
Measured: Baseline and following a single treatment, an average of one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start23 Jan 2020
- Primary completion8 Feb 2020
- Study completion8 Feb 2020
Why it stopped: Due to unforeseen slow enrollment and a shift in corporate resources due to the COVID-19 impact.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast Cancer Related LymphedemaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tactile Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073823
- Sponsor's protocol ID
- 4070
- Status last verified
- Jan 2023
- First submitted
- 25 Jul 2019
- Last updated
- 18 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Evaluating Flexitouch® Plus With a Therapy Cycle Software Modification in Patients With Unilateral Breast Cancer-Related Lymphedema (BCRL)
- ClinicalTrials.gov ID
- NCT04073823
- Acronym / sponsor ID
- 4070
- Conditions
- Breast Cancer Related Lymphedema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to unforeseen slow enrollment and a shift in corporate resources due to the COVID-19 impact.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Tactile MedicalIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 8 Feb 2020 (actual)
- Study completion
- 8 Feb 2020 (actual)
- First posted
- 29 Aug 2019 (actual)
- Results
- Posted 17 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to demonstrate equivalency in treatment effect, as determined by objective measurements, between the modified therapy cycle software and the FDA-cleared Flexitouch therapy cycle software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexitouch Plus | Active comparator | Device: Flexitouch Plus |
| Flexitouch Plus with SW | Experimental | Device: Flexitouch Plus FT with software modification |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female 18 years of age or older
- Diagnosis of unilateral breast cancer-related lymphedema
- Stage I or early stage II lymphedema without severe fibrosis at the time of enrollment
- ≥ 5% volume difference between affected and unaffected arm as verified via perometry
- Willing and able to give informed consent
Key exclusion criteria (13 listed)
- In-home use of PCD within previous 3 months
- Therapist or self-administered manual lymph drainage (MLD) within previous 1 week
- Mastectomy or lymph node removal on side without lymphedema
- Bilateral lymphedema
- Heart failure (acute pulmonary edema, decompensated acute heart failure)
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 PlusFlexitouch Plus full arm and core treatment | Device | Flexitouch Plus |
| Flexitouch Plus FT with software modificationAlso: FT-SWFlexitouch Plus full arm and trunk/chest treatment | Device | Flexitouch Plus with SW |
Primary outcome
Lymphatic Activation
Time frame: Baseline and following a single treatment, an average of one hour
Comparison of the change in the rate of lymphatic propulsion events from the pre-treatment values to the post-treatment values for both the affected and contralateral limbs using the investigational technique of near infrared-fluorescent (NIRF) imaging.
Changes in Swelling - MoistureMeterD
Time frame: Baseline and following a single treatment, an average of one hour
Comparison of the percent change in local tissue water from the pre-treatment values to the post-treatment values on the affected limb using MoistureMeterD.
Changes in Swelling - Perometry
Time frame: Baseline and following a single treatment, an average of one hour
Swelling in the affected and contralateral limb as assessed using local tissue water content
Percent Change in Skin Thickness From Baseline to After Treatment.
Time frame: Baseline and following a single treatment, an average of one hour
Skin changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
Incidence of Adverse Events
Time frame: 24-Hour Follow-Up
Adverse events reported between treatment and the 24-hour follow-up
Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging
Time frame: Baseline and following a single treatment, an average of one hour
Comparison of the number of subjects with an increase in vessels for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging.
Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging
Time frame: Baseline and following a single treatment, an average of one hour
Comparison of the change in dermal backflow from the pre-treatment values to the post-treatment values as the sum of the volume of area for all locations for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging
Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner)
Time frame: Baseline and following a single treatment, an average of one hour
Compare the percent of participants by arm demonstrating a decrease in limb volume for the affected and contralateral limbs via Perometry (LymphaTech 3D Scanner)
Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound)
Time frame: Baseline and following a single treatment, an average of one hour
Comparison of the percent of participants by arm demonstrating a decrease in thickness for each site, separating skin and subcutaneous changes, on the affected limb via Ultrasound
Absolute Change in Skin Thickness From Baseline to After Treatment
Time frame: Baseline and following a single treatment, an average of one hour.
Skin Changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Flexitouch Plus FT with software modification in people with Breast Cancer Related Lymphedema, run by Tactile Medical 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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 18 Jan 2023. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lymphatic Activation (time frame: Baseline and following a single treatment, an average of one hour). The study lists 10 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 18 Jan 2023.