RecruitingNCT06597240

Home Monitoring During Chemoradiation

At-home Monitoring of Patients During Chemoradiation for Oesophageal CanceR: the AMCOR Trial

Sponsor

University Medical Center Groningen

Enrollment

30 participants

Start Date

May 15, 2025

Study Type

OBSERVATIONAL

Conditions

Locally Advanced Oesophageal Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients with esophageal or stomach-esophageal junction cancer who are receiving combined chemotherapy and radiation therapy (chemoradiation) can safely monitor their own health at home using digital tools, reducing the need for in-person visits. **You may be eligible if...** - You are 18 or older - You have confirmed esophageal or gastroesophageal junction cancer - You are scheduled to receive chemoradiation using carboplatin and paclitaxel - You are able to carry out home-based measurements on your own **You may NOT be eligible if...** - You have a mental health condition that would prevent you from understanding the consent process or doing home measurements independently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAMCOR

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.

Locations(1)

University Medical Center Groningen

Groningen, Netherlands

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NCT06597240