Head and Neck Squamous Cell Carcinoma HNSCCWEBNECKNCT07190755
Impact of Patient-Reported Outcomes for Symptom Monitoring in Patients Followed for Head and Neck Squamous Cell Carcinoma (HNSCC)
A study testing Remote symptoms moniotring in people with Head and Neck Squamous Cell Carcinoma HNSCC, run by Centre Henri Becquerel at 2 sites in France.
Trial summary
The use of digital strategies to systematically monitor patients' symptoms in clinical settings allows problems to be detected at an early stage before they worsen or lead to complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma HNSCC
- What is being tested?
- Remote symptoms moniotring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Oct 2025to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Henri Becquerel
Rouen
Sébastien Thureau, MD, PhD, +33232082992, sebastien.thureau@chb.unicancer.fr
- Not yet recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy
Jean-Christophe Faivre, MD, +33383598349, jc.faivre@nancy.unicancer.fr
About this study
Official title: 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
The use of digital strategies to systematically monitor patients' symptoms in clinical settings allows problems to be detected at an early stage before they worsen or lead to complications. In this study, the hypothesis is that the proportion of patients with a weight loss of at least 5% between before radiotherapy/radiochemotherapy and 3 months after treatment would be lower with optimised care thanks to remote monitoring using a medical telemonitoring solution in oncology.
- Being tested
- Remote symptoms moniotring
- Keywords
- head and neck squamous cell carcinoma, symptoms monitoring, web monitoring
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote symptoms moniotringOther
Participants in the intervention arm will use Resilience PRO, a mobile phone application regularly asking participants about their symptoms. For clinically important symptoms, an alert is sent to the care team that can incorporate that information to timely adjust the care of the participants.
| Study group | Role | What they receive |
|---|---|---|
| Standard arm | No intervention | patients will be followed as standard of care |
| remote symptoms monitoring | Experimental | Participants in the intervention arm will use Resilience PRO, a mobile phone application regularly asking participants about their symptoms. For clinically important symptoms, an alert is sent to the care team that can incorporate that information to timely adjust the care of the participants. Receives: Other: Remote symptoms moniotring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of remote monitoring of symptoms on weight loss
Proportion of patients with at least a 5% reduction in weight 3 months after treatment compared to the consultation at the start of radiotherapy or radiochemotherapy
Measured: 3 months after treatment
Secondary outcomes (2)
Impact of remote symptoms monitoring on global survival
Time beetween inclusion and death for any cause
Measured: 12 month after treatment
Impact of remote symptoms monitoring on global survival
Time beetween inclusion and death for any cause
Measured: 18 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start15 Oct 2025
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma HNSCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Collaborators
- Resilience
- Responsible party
- Sponsor
- Investigators
- Sebastien Thureau, MD,PhD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190755
- Sponsor's protocol ID
- CHB24.06
- Acronym
- WEBNECK
- Status last verified
- Dec 2025
- First submitted
- 17 Sep 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07190755
- Acronym / sponsor ID
- WEBNECK / CHB24.06
- Keywords
- head and neck squamous cell carcinoma, symptoms monitoring, web monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Collaborators
- Resilience
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of digital strategies to systematically monitor patients' symptoms in clinical settings allows problems to be detected at an early stage before they worsen or lead to complications. In this study, the hypothesis is that the proportion of patients with a weight loss of at least 5% between before radiotherapy/radiochemotherapy and 3 months after treatment would be lower with optimised care thanks to remote monitoring using a medical telemonitoring solution in oncology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard arm | No intervention | –patients will be followed as standard of care |
| remote symptoms monitoring | Experimental | Other: Remote symptoms moniotringParticipants in the intervention arm will use Resilience PRO, a mobile phone application regularly asking participants about their symptoms. For clinically important symptoms, an alert is sent to the care team that can incorporate that information to timely adjust the care of the participants. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged over 18 and under 75 years WHO score < 2,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote symptoms moniotringParticipants in the intervention arm will use Resilience PRO, a mobile phone application regularly asking participants about their symptoms. For clinically important symptoms, an alert is sent to the care team that can incorporate that information to timely adjust the care of the participants. | Other | remote symptoms monitoring |
Primary outcome
Impact of remote monitoring of symptoms on weight loss
Time frame: 3 months after treatment
Proportion of patients with at least a 5% reduction in weight 3 months after treatment compared to the consultation at the start of radiotherapy or radiochemotherapy
2 secondary outcomes
Impact of remote symptoms monitoring on global survival
Time frame: 12 month after treatment
Impact of remote symptoms monitoring on global survival
Time frame: 18 month after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sebastien Thureau, MD,PhD principal investigator
Centre Henri Becquerel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote symptoms moniotring in people with Head and Neck Squamous Cell Carcinoma HNSCC, run by Centre Henri Becquerel at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastien Thureau, MD,PhD (+33232082992, sebastien.thureau@chb.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of remote monitoring of symptoms on weight loss (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.