Patient-reported symptom monitoring for people with head and neck cancer
Impact of Patient-Reported Outcomes for Symptom Monitoring in Patients Followed for Curative Treatment of Head and Neck Squamous Cell Carcinoma (HNSCC) With Radiotherapy or Chemoradiotherapy
NA · Centre Henri Becquerel · NCT07190755
This trial will test whether remote digital symptom monitoring during and after radiotherapy helps reduce significant weight loss in adults treated for localized head and neck squamous cell carcinoma.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Centre Henri Becquerel (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Rouen and 1 other locations) |
| Trial ID | NCT07190755 on ClinicalTrials.gov |
What this trial studies
Adults with localized head and neck squamous cell carcinoma who are receiving curative radiotherapy or radiochemotherapy will use a medical telemonitoring solution to report symptoms remotely during treatment and for follow-up. Clinicians receive these patient-reported outcomes and can provide timely supportive care, including nutritional interventions, when problems are detected. The primary outcome is the proportion of patients who lose at least 5% of body weight between before radiotherapy and three months after treatment. Participation requires access to a smartphone or the internet and follow-up at one of the participating cancer centers in France.
Who should consider this trial
Good fit: Adults aged 18–74 with localized head and neck squamous cell carcinoma planned for curative radiotherapy or radiochemotherapy, WHO performance status <2, able to use a smartphone or the internet, and able to give informed consent are ideal candidates.
Not a fit: Patients with recent other cancers, prior ENT radiotherapy, progressive or metastatic disease, pregnant or breastfeeding women, those under legal protection, or those unable to use the telemonitoring tool (for example due to blindness or lack of internet access) are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, remote symptom monitoring could reduce treatment-related weight loss and related complications by prompting earlier symptom control and nutritional support.
How similar studies have performed: Remote symptom monitoring with patient-reported outcomes has improved detection and some clinical outcomes in other oncology settings, but evidence specifically showing prevention of weight loss in head and neck cancer is limited and this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged over 18 and under 75 years WHO score \< 2, * Treated for localised heand and neck cancer of the squamous cell carcinoma type for which curative treatment has been chosen and receiving radiotherapy or radio-chemotherapy exclusively or as an adjuvant with the aim of cure * Having signed the informed consent form, * Affiliated with or beneficiary of a social protection scheme, * Access to a smartphone or the internet, Exclusion Criteria: * History of other neoplastic disease less than 2 years ago or progressive disease, * History of ENT radiotherapy, * Pregnant or breastfeeding women, * Protected adults (under guardianship, curatorship or judicial protection), * Patients participating in a therapeutic study, * Patients unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological or geographical issues, etc.), patients with blindness preventing the use of the medical telemonitoring solution in oncology.
Where this trial is running
Rouen and 1 other locations
- Centre Henri Becquerel — Rouen, France (RECRUITING)
- Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Sebastien Thureau, MD,PhD — Centre Henri Becquerel
- Study coordinator: Sebastien Thureau, MD,PhD
- Email: sebastien.thureau@chb.unicancer.fr
- Phone: +33232082992
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: Head and Neck Squamous Cell Carcinoma HNSCC, head and neck squamous cell carcinoma, symptoms monitoring, web monitoring