Clinical trial NCT04983342: Apollo Device for Metastatic Breast Cancer (MBC)
Official title: Apollo Device for Fatigue in Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Metastatic Breast Carcinoma
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Apollo Neuroscience, Inc.
First posted: 2021-07-30
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm pilot design -pre and post
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a single-arm, open label pilot intervention study with outcomes measured by electronic survey and chart review evaluating a wearable device called Apollo, which is similar to a FitBit but emits vibrations. Our primary objective is to assess whether or not Apollo can help with symptoms of fatigue and pain in patients with Metastatic Breast Cancer (MBC).

Detailed description: This study aims to provide preliminary data on the efficacy and tolerability of the Apollo device in the management of fatigue and pain in patients with Metastatic Breast Cancer (MBC).

Apollo is about the size of an Apple Watchand can be worn on the ankle, wrist, or armwith two adjustable fabric straps. Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy. In addition to the wearable, Apollo is a software system that curates music for the body, rather than for the ears. The scientific principles guiding the use of Apollo and mechanistic understanding of its effects on the body are consistent with the understanding of how music and therapeutic touch effect the body to convey feelings of energy, focus, or relaxation by sending safety signals to the emotional cortex (limbic system) in the brain. Similar to music and touch used to facilitate a healing response in the body, there are no known side effects to this type of therapy.

The PROMIS-Fatigue scale and the Functional Assessment of Cancer Therapy Fatigue (FACT-F) are instruments that have been previously validated in multiple diseases and will be used in this study. Preliminary data on indices of pain, use of PRN pain medications, health-related quality of life, sleep, anxiety and depression and tolerability/frequency of use with the Apollo device in MBC will also be evaluated using:

* PROMIS pain scale
* Use of pain medications
* Health-related quality of life (HRQOL) using PROMIS-29
* PROMIS Sleep
* Hospital Anxiety and Depression Scale (HADS)
* Usage data from Apollo app

This study aims to identify improvement of fatigue symptoms from baseline after 4 and 8 weeks of Apollo use. Improvements in pain, quality of life, use of PRN pain medication, anxiety and sleep.

Eligibility criteria: Inclusion Criteria:

* Metastatic breast cancer diagnosis
* Fatigue score of 4 or greater at last clinic visit

Exclusion Criteria:

* Not able to read and understand English
* Use of Beta Blockers,
* Use of medications for serious mental illness

Primary outcomes:
measure: Change in Fatigue (PROMIS-Fatigue)
timeFrame: Up to 8 weeks
measure: Change in Fatigue (FACT-F)
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Degree of Pain
timeFrame: Up to 8 weeks
measure: Use of pain medications
timeFrame: Up to 8 weeks
measure: Health Related quality of life (HRQOL)
timeFrame: Up to 8 weeks
measure: Promis Sleep Measurement
timeFrame: Up to 8 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh School of Nursing
name: Margaret Q Rosenzweig
role: PRINCIPAL_INVESTIGATOR
References: