At-home monitoring for patients undergoing chemoradiation for head and neck cancer
At-home Monitoring of Patients During Chemoradiation for Oesophageal CanceR: the AMCOR Trial
University Medical Center Groningen · NCT06597240
This study is testing whether at-home monitoring can help patients with head and neck cancer manage their treatment better during and after chemoradiation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06597240 on ClinicalTrials.gov |
What this trial studies
This observational feasibility study involves continuous monitoring of 30 patients with locally advanced head and neck carcinoma from one week before to three weeks after chemoradiation. Participants will use a monitoring kit that includes devices for measuring blood pressure, oxygen saturation, body weight, temperature, and physical activity, with data sent to an online portal for review by investigators. Additionally, patients will perform at-home finger prick tests to assess creatinine levels, enabling early detection of complications and better management of their treatment. The goal is to evaluate the feasibility and potential benefits of this home monitoring approach in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed locally advanced head and neck carcinoma who are scheduled to receive chemoradiotherapy.
Not a fit: Patients with altered mental status or psychiatric conditions that hinder their ability to understand or comply with the study requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient safety and treatment adherence by allowing for timely interventions based on real-time health data.
How similar studies have performed: While the specific approach of at-home monitoring during chemoradiation is novel, similar studies have shown promise in other cancer treatments, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 at the time of signing informed consent. * Histologically proven adenocarcinoma, squamous cell carcinoma or mixed type of the oesophagus or gastro-oesophageal junction. * Indication for definitive or neoadjuvant CRT, with chemotherapy that consists of weekly carboplatin/paclitaxel. * Written, informed consent. * Ability to comply with all protocol required actions (at home measurements are done individually by the participant him- or herself). Exclusion Criteria: \- Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent or the carrying out of the measurements at home.
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Rudolf S.N. Fehrmann, MD, PhD — University Medical Center Groningen
- Study coordinator: Rudolf S.N. Fehrmann, MD, PhD
- Email: r.s.n.fehrmann@umcg.nl
- Phone: +31503611419
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.
Conditions: Locally Advanced Oesophageal Cancer, at-home monitoring, chemoradiation, oesophageal cancer