Home Monitoring During Chemoradiation
AMCOR
At-home Monitoring of Patients During Chemoradiation for Oesophageal CanceR: the AMCOR Trial
1 other identifier
observational
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2023
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
May 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
August 14, 2025
June 1, 2025
1.4 years
January 17, 2023
August 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the feasibility of at home monitoring in addition to standard of care
To determine the feasibility of at home monitoring in addition to standard care of patients with oesophageal cancer during chemoradiotherapy. Feasible is defined as ≥80% of measurements completed in ≥80% of the patients.
From one week before the start of treatment until three weeks after the end of treatment
Secondary Outcomes (7)
Determine completion rates
From one week before the start of treatment until three weeks after the end of treatment
Determine the number of extra hospital visits
From one week before the start of treatment until three weeks after the end of treatment
Determine the number of extra telephone contacts
From one week before the start of treatment until three weeks after the end of treatment
Determine radiotherapy and chemotherapy completion rates
From one week before the start of treatment until three weeks after the end of treatment
Assess changes in quality of life from baseline in the domains overall health/QoL score, dysphagia and fatigue of the validated EORTC QLQ-C30 and QLQ-OES18.
From one week before the start of treatment until three weeks after the end of treatment
- +2 more secondary outcomes
Study Arms (1)
AMCOR
Patients \>18 years with locally advanced oesophageal cancer requiring chemoradiotherapy with curative intent.
Interventions
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.
Eligibility Criteria
Patients with head and neck carcinoma eligible for chemoradiation with a curative intent, and chemotherapy that consists of cisplatin will be included in this study.
You may qualify if:
- 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).
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Medical Center Groningenlead
- Siemens Corporation, Corporate Technologycollaborator
- Nova Biomedicalcollaborator
Study Sites (1)
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rudolf S.N. Fehrmann, MD, PhD
University Medical Center Groningen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2023
First Posted
September 19, 2024
Study Start
May 15, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
August 14, 2025
Record last verified: 2025-06