N/A
N=29
Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema.
Breast Cancer Lymphedema
Bottom Line
View on ClinicalTrials.gov: NCT04432727 ↗Enrolled (actual)
29
Serious AEs
3.5%
Results posted
May 2023
Primary outcome: Primary: Compliance Measured as the Average Number of Treatments Per Week — 5.3; 5.2 treatments/week
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Flexitouch Plus with Cellular Connectivity (FT-CC) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Tactile Medical
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compliance Measured as the Average Number of Treatments Per Week |
5.3; 5.2 | — |
| SECONDARY Compliance With Device Use. |
0; 1; 6; 4; 7; 5 | — |
| SECONDARY Quality of Life Assessment Via LYMQOL ARM |
7.6; 6.6 | — |
| SECONDARY Quality of Life Assessment Via SF-36 Physical Functioning Domain Score |
4; 8; 4; 0; 6; 3 | — |
| SECONDARY Quality of Life Assessment Via LSIDS-A Score |
12; 8; 0; 0; 1; 3 | — |
Summary
The objective of this study is to demonstrate the feasibility of using the Flexitouch Plus with Cellular Connectivity (FT-CC) to monitor device use data to determine if reminders to patients impact compliance, and to identify the impact device compliance has on arm girth, quality of life (QOL), and symptom assessment.
Eligibility Criteria
Inclusion Criteria
- Female 18 years of age or older
- Diagnosis of unilateral breast cancer-related lymphedema
- Willing and able to give informed consent (remotely or in person)
- Willing and able to comply with the study protocol requirements and all study-related visit requirements, including the ability to participate remotely
- Willing and able to receive text messages from sponsor
Exclusion Criteria
- In-home use of PCD within previous 3 months
- Phase-one CDT within previous 1 month or planned phase-one CDT during study participation Phase-one CDT defined as professionally administered MLD and/or multi-layer short stretch compressive bandaging.
- Inability to be fit for PCD garments
- Heart failure (acute pulmonary edema, decompensated acute heart failure)
- Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
- Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk
- Currently receiving treatment for cancer with curative intent.
- Any circumstance where increased lymphatic or venous return is undesirable
- Currently pregnant or trying to become pregnant
- Known inability to receive cell phone connection where FT-CC therapy will be administered
Data sourced from ClinicalTrials.gov (NCT04432727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.