Clinical trial · Interventional
Apollo Device for Metastatic Breast Cancer (MBC)
Apollo Device for Fatigue in Metastatic Breast Cancer
NCT04983342CI-TRIAL-00078113completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Metastatic Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apollo Armband | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apollo Armband
- description
- 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.
- interventionNames
- Device: Apollo Armband
Primary outcomes (2)
- measure
- Change in Fatigue (PROMIS-Fatigue)
- timeFrame
- Up to 8 weeks
- description
- Change from baseline to 4 and then 8 weeks as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue scale, which measures the presence of fatigue and its interference with life. PROMIS-Fatigue includes 6 items with scores 1-5 for each item, total scores 6-30. Lower scores indicate less fatigue and interference from fatigue.
- measure
- Change in Fatigue (FACT-F)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.