Smartwatch monitoring of vital signs during chemotherapy
The Use of Proa-active Monitoring by Measuring Vital Signs Using a Fitbit for a 3-month Period Before, During, and After Chemotherapy in Patients With Cancer
This will try using a Fitbit smartwatch to see if it can detect changes in vital signs in adults with stomach or esophageal cancer during chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 175 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT06680778 on ClinicalTrials.gov |
What this trial studies
This single-center prospective observational project enrolls adults with stomach or esophageal cancer starting systemic chemotherapy at Erasmus MC. Participants begin wearing a Fitbit about a week before their first chemotherapy cycle (target 4–7 days) and are asked to wear it day and night through the first two cycles or up to three months to continuously record vital signs. Investigators review device data at clinic visits at the start of subsequent cycles to compare on-treatment measurements with each patient's baseline. The aim is to see whether a consumer wearable reliably captures chemotherapy-related changes in heart rate, activity, and other parameters that could signal emerging clinical problems.
Who should consider this trial
Good fit: Adults (≥18) with stomach or esophageal cancer who are about to start chemotherapy, can use a Fitbit, speak Dutch, and can give informed consent.
Not a fit: Patients with cognitive impairment or severe emotional instability, those already enrolled in an exercise trial, or those who cannot use a Fitbit or travel to the center are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could enable earlier detection of physiological changes during chemotherapy and prompt timelier clinical follow-up or intervention.
How similar studies have performed: Prior feasibility studies using consumer wearables have shown they can capture activity and heart-rate trends and sometimes flag deterioration, but robust evidence specifically in chemotherapy populations is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years; * Diagnosis of stomach or esophageal cancer with an indication of starting chemotherapy * Knowledge how to handle a Fitbit * Mastery of Dutch language * Able and willing to give written informed consent Exclusion Criteria: * Cognitive disorders or severe emotional instability * Already participating in an exercise trial
Where this trial is running
Rotterdam, South Holland
- Erasmus University Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Jason den Duijn, MSc.
- Email: j.denduijn@erasmusmc.nl
- Phone: +31107040704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.