What side effects are associated with this type of intervention?

Common treatments for breast cancer, including chemotherapy, radiation therapy, and hormonal therapy, are associated with a range of side effects. Chemotherapy can cause alopecia, fatigue, nausea, peripheral neuropathy, and increased risk of infection. Radiation therapy may lead to skin irritation, fatigue, and changes in breast appearance. Hormonal therapies, such as tamoxifen and aromatase inhibitors, can result in hot flashes, joint pain, and bone density loss. The Apollo trial, which uses vibration-based sensory stimulation, aims to address symptoms like fatigue and pain, which are prevalent among breast cancer patients undergoing these treatments.

What prior FDA approvals exist?

The Apollo device, which uses vibration-based sensory stimulation, is currently being studied for its potential to alleviate symptoms of fatigue and pain in patients with metastatic breast cancer. While there is no specific mention of prior FDA approvals for vibration-based sensory stimulation devices for breast cancer treatment, the FDA has approved various drugs and therapies for breast cancer, including hormone therapies, chemotherapy, targeted therapies, and immunotherapies. These treatments aim to manage and reduce the progression of the disease, improve quality of life, and alleviate symptoms associated with breast cancer.

What other types of research exist?

Promising alternatives to Apollo for breast cancer patients include non-invasive neuromodulation, which has shown effectiveness in reducing tremor and may have applications in pain management. Biomechanical loading devices, which apply external forces to reduce tremor, could also be adapted for pain relief. Additionally, integrative therapies such as biofeedback-assisted relaxation and mindfulness-based interventions may offer benefits for managing pain and improving quality of life.

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Wearable Device

Apollo Device for Breast Cancer

N/A

Waitlist Available

Led By Margaret Q Rosenzweig

Research Sponsored by Margaret Quinn Rosenzweig

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Metastatic breast cancer diagnosis

Fatigue score of 4 or greater at last clinic visit

Must not have

Use of medications for serious mental illness

Use of Beta Blockers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a wearable device called Apollo, which emits gentle vibrations, to help reduce fatigue and pain in patients with Metastatic Breast Cancer. The device works by sending calming signals to the brain through vibrations, aiming to reduce stress and improve energy.

Who is the study for?

This trial is for individuals with Metastatic Breast Cancer (MBC) who experience significant fatigue. Participants must have had a fatigue score of 4 or higher at their last clinic visit, be able to read and understand English, and not be on medications for serious mental illness or beta blockers.

What is being tested?

The Apollo Armband, a wearable device that emits vibrations similar to a FitBit, is being tested in this study. The goal is to see if it can reduce symptoms of fatigue and pain in patients with MBC through self-reported surveys and medical chart reviews.

What are the potential side effects?

Since the Apollo Armband uses vibrations, potential side effects may include discomfort where the armband touches the skin or an allergic reaction to its materials. However, specific side effects are not detailed as it's non-invasive.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer has spread to other parts of my body.

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I reported a fatigue level of 4 or higher at my last clinic visit.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am taking medication for a serious mental illness.

Select...

I am currently taking beta blockers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Fatigue (FACT-F)

Change in Fatigue (PROMIS-Fatigue)

Secondary study objectives

Degree of Pain

Health Related quality of life (HRQOL)

Hospital Anxiety and Depression Scale (HADS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Apollo ArmbandExperimental Treatment1 Intervention

Armband that can be worn on the ankle, wrist, or arm with 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, combatting fatigue and pain.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Apollo Armband

2021

N/A

~30

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include surgery, chemotherapy, radiation therapy, hormone therapy, and targeted therapy. Surgery involves removing the tumor, while chemotherapy uses drugs to kill cancer cells. Radiation therapy uses high-energy rays to destroy cancer cells, and hormone therapy blocks hormones that fuel certain cancers. Targeted therapy attacks specific molecules involved in cancer growth. The Apollo device, which uses vibration-based sensory stimulation, aims to alleviate symptoms like fatigue and pain by modulating the nervous system. Understanding these mechanisms helps patients and doctors choose the most effective treatment plan, manage side effects, and improve quality of life.