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Home Monitoring During Chemoradiation

NCT06597240 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-08-14

No results posted yet for this study

Summary

Chemoradiotherapy is part of standard treatment for patients with locally advanced oesophageal cancer. Some patients with oesophageal cancer treated with chemoradiotherapy do not complete treatment due to toxicity, or face complications after treatment. Therefore, there is a need for better tools for assessing patients' fitness for chemoradiotherapy and to pick up early signals of deteriorating overall physical condition and complications during and after treatment to timely implement supportive care measures. Tools enabling monitoring physical activity, vital parameters and creatinine concentration in the blood at home are available but have not yet been implemented in patients undergoing chemoradiotherapy for oesophageal cancer. The feasibility and added value remain unknown.

Conditions

  • Locally Advanced Oesophageal Cancer

Interventions

DEVICE

AMCOR

Participants will collect biometric and quality of life data for 9 or 10 weeks at home, depending on treatment schedule. Continuous step counting will be used to register physical activity. Participants will be asked to measure their blood pressure, heart rate, oxygen saturation level, pain level and temperature each morning, and weight 3 times a week. These measurements consume little time and are not harmful. Once a week they will perform a finger stick test themselves to determine creatinine concentration in the blood. In addition, patients fill in three questionnaires at four time points which will take approximately 20 minutes to complete per time point. We do not foresee reasonable risks of these diagnostic procedures for the participants.

Sponsors & Collaborators

  • Siemens Corporation, Corporate Technology

    collaborator INDUSTRY

  • Nova Biomedical

    collaborator INDUSTRY

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Rudolf S.N. Fehrmann, MD, PhD · University Medical Center Groningen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06597240 on ClinicalTrials.gov