Clinical trial NCT04432727: Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema.
Official title: A Feasibility Study Evaluating the Impact Flexitouch Plus With Connectivity Has on Compliance in Patients With Breast Cancer-Related Lymphedema (BCRL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Lymphedema
Lead sponsor: Tactile Medical
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a multi-center, on label, prospective, randomized, two-arm feasibility study that plans to enroll 30 female subjects in the United States. In an effort to reduce potential exposure to COVID-19, all study assessments are intended to be performed in a contactless manner (i.e., telephone, video conference, etc). If a subject passes the initial screening requirements via medical history and expresses interest in the study an informed consent form will be provided to them. Once consent has been obtained they will undergo a baseline visit where they will be randomized to one of two treatment groups: PASSIVE FT-CC (text messages reminders will not be sent to subjects) and ACTIVE FT-CC (text messages reminders will be sent if subject does not use the device for 2 consecutive days). Randomization was incorporated into the study to determine if ACTIVE FT-CC affects device use. A total of 2 follow-up visits will be conducted over a 60-day period.

Eligibility criteria: Inclusion Criteria:

1. Female 18 years of age or older
2. Diagnosis of unilateral breast cancer-related lymphedema
3. Willing and able to give informed consent (remotely or in person)
4. Willing and able to comply with the study protocol requirements and all study-related visit requirements, including the ability to participate remotely
5. Willing and able to receive text messages from sponsor

Exclusion Criteria:

1. In-home use of PCD within previous 3 months
2. 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.
3. Inability to be fit for PCD garments
4. Heart failure (acute pulmonary edema, decompensated acute heart failure)
5. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
6. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk
7. Currently receiving treatment for cancer with curative intent.
8. Any circumstance where increased lymphatic or venous return is undesirable
9. Currently pregnant or trying to become pregnant
10. Known inability to receive cell phone connection where FT-CC therapy will be administered

Primary outcomes:
measure: Compliance Measured as the Average Number of Treatments Per Week
timeFrame: 60 Days
Secondary outcomes:
measure: Compliance With Device Use.
timeFrame: Through 60 days after device training
measure: Quality of Life Assessment Via LYMQOL ARM
timeFrame: Changes through 60 days after device training
measure: Quality of Life Assessment Via SF-36 Physical Functioning Domain Score
timeFrame: Changes through 60 days after device training
measure: Quality of Life Assessment Via LSIDS-A Score
timeFrame: Changes through 60 days after device training
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Albany
country: United States
facility: St. Peter's Hospital
state: New York
city: Troy
country: United States
facility: Samaritan Hospital Hildegard Medicus Cancer Center
state: New York
Study officials:
affiliation: St. Peter's Health Partners
name: Sarah Pesek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Louisville
name: Nicolas Ajkay, MD
role: PRINCIPAL_INVESTIGATOR
References: