Cancer of Head and NeckRORCNCT02892487
Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer
A study testing Swallowing therapy in people with Cancer of Head and Neck, run by Rennes University Hospital at 21 sites in France.
Trial summary
Toxicity and mainly dysphagia have increased in head and neck cancers as chemoradiation indications have risen over the last decade, leading to a significant loss of quality of life for patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Head and Neck
- What is being tested?
- Swallowing therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 21 sitesFrance
- Study dates
- 9 Dec 2016to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient treated for histologically proven head and neck cancer (oral cavity, oropharynx, or hypopharynx cancer) of stages I-IV or larynx cancer of stages II-IV, all histologic type, without distant metastasis
- Indication of curative radiotherapy alone or associated to chemotherapy or targeted therapy, without planned surgery
- WHO (World Health Organization) Performance Status 0, 1 or 2
- Sufficient cognitive capacities to complete a QoL questionnaire (evaluation by the physician at inclusion)
- Written informed consent
- Patients with health insurance
Who cannot join
- Previous radiotherapy or surgery of the upper aerodigestive tract
- Cancer of paranasal sinuses or nasopharynx or skull base
- Medical history of nervous system disease associated to significant sequelae in terms of dysphagia
- Pregnant or breast-feeding woman
- Patient under guardianship, trusteeship or judicial protection
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
Brest University Hospital
Brest
Caen University Hospital
Caen
Centre François Baclesse
Caen
Clermont-Ferrand University Hospital
Clermont-Ferrand
Le Mans Hospital
Le Mans
Lille University Hospital
Lille
Bretagne Sud Hospital
Lorient
Lyon University Hospital
Lyon
Marseille University Hospital
Marseille
Centre Alexis Vautrin
Nancy
Nantes University Hospital
Nantes
Centre Antoine Lacassagne
Nice
Tenon Hospital
Paris
Poitiers University Hospital
Poitiers
Clinique La Sagesse
Rennes
Rennes University Hospital
Rennes
Strasbourg University Hospital
Strasbourg
Toulouse University Hospital
Toulouse
Tours University Hospital
Tours
Bretagne Atlantique Hospital
Vannes
Institut Gustave Roussy
Villejuif
About this study
Toxicity and mainly dysphagia have increased in head and neck cancers as chemoradiation indications have risen over the last decade, leading to a significant loss of quality of life for patients. Recently, many retrospective studies and two evidence-based and systematic reviews on strategies to reduce radiation-induced dysphagia have suggested a trend toward benefit for a preventive swallowing exercise program.
The main hypothesis of this study is that an early active swallowing therapy can improve the Quality of Life (QoL) of patients treated by radiotherapy for head and neck cancer.
The study will be a randomized controlled, open-label, multicentric phase III clinical trial comparing early active swallowing therapy versus non specific swallowing management (usual care).
Read the detailed description
Patients in both groups will receive dietary and postural advice from the treating physician. Patients in the experimental group will be treated with an early active swallowing therapy including a consultation with a speech and language therapist twice a week and a detailed program of swallowing auto-exercises twice a day, from the start to one month after the end of radiotherapy. All speech therapists will be given precise guidelines based on the current state of the art and knowledge. All patients will be analyzed in intent-to-treat.
Two ancillary studies will complete this global concept of the evaluation and prediction of severe alteration of Quality of Life (QoL) and Dysphagia.
- A first study will evaluate videoradioscopy. Its objectives are to evaluate the ability of videoradioscopy at 3 months to predict poor QoL at 6 and 12 months, to identify videoradioscopic predictors of severe dysphagia, asymptomatic aspirations, cricopharyngeal stenoses and active swallowing rehabilitation efficiency. Each patient of both arms of the main study will undergo a videoradioscopy before the beginning of the radiation delivery (baseline evaluation), and at 3 and at 12 months. Data analysis will be centralized and will concern: APS (Aspiration and Penetration Scale) score, residue, Defective Laryngeal elevation, pharyngoesophageal sphincter dysfunction. Data will be correlated to the parameters of the main study in order to establish predictive models.
- A second ancillary study will evaluate the dose-volume histograms of radiotherapy. The objectives are to identify predictors of dysphagia and of active swallowing rehabilitation efficiency, and to establish "2D" and "3D" predictive models of dysphagia. Imaging and dosimetric data (IMRT (Intensity Modified RadioTherapy) planning) and dose-volume histogram will be collected from the patients of the main clinical trial. Analysis will be centralized. Data will be correlated to the parameters of the main study in order to establish predictive models.
- Conditions
- Cancer of Head and Neck
- Being tested
- Swallowing therapy
- Keywords
- Quality of life, Radiotherapy, Dysphagia, Oral cavity, Oropharynx, Hypopharynx, Larynx, Swallowing rehabilitation, Toxicity
- Medical subject headings
- Head and Neck Neoplasms, Deglutition Disorders, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowing therapyOther
Patients will undergo active swallowing therapy with a speech and language therapist (twice a week) combined to a detailed program of swallowing auto-exercises (twice a day) from start of radiotherapy to one month after the end.
| Study group | Role | What they receive |
|---|---|---|
| Early active swallowing therapy | Experimental | Not described Receives: Other: Swallowing therapy |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients experiencing a clinically relevant improvement defined as a decrease of at least 10 points of the score HNSW ( 6 months after radiotherapy compared with the score before radiotherapy
HNSW = Head and Neck Swallowing Questionnaire
Measured: 6 months after radiotherapy
Secondary outcomes (13)
EORTC QLQ-C30 score
EORTC QLQ = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire
Measured: Baseline, 3, 6 and 12 months after radiotherapy
EORTC H&N35 score
EORTC H\&N = European Organisation for Research and Treatment of Cancer Head and Neck questionnaire
Measured: Baseline, 3, 6 and 12 months after radiotherapy
MFI-20 score
MFI = Multidimensional Fatigue Inventory
Measured: Baseline, 3, 6 and 12 months after radiotherapy
Body Mass index (BMI)
in kg/m^2
Measured: Baseline, 3, 6 and 12 months after radiotherapy
Functional Oral Intake Scale (FOIS)
Measured: Baseline, 3, 6 and 12 months after radiotherapy
Overall duration of enteral nutrition
Measured: 12 months after radiotherapy
Total treatment duration
Measured: 12 months after radiotherapy
Number of treatment interruptions
Measured: 12 months after radiotherapy
Number of patients with adverse events
Measured: End of radiotherapy (an average of 2 months after baseline), 1, 3, 6 and 12 months after radiotherapy
Swallowing specific Quality of Life (SWAL-QOL) score
Measured: Baseline, 3, 6 and 12 months after radiotherapy
Number of patients with aspiration and penetration determined by APS (Aspiration and Penetration Scale) scoring
Measured: Baseline, 3, 6 and 12 months after radiotherapy
Rate of global survival
Measured: 12 months after radiotherapy
Rate of survival without recurrence
Measured: 12 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start9 Dec 2016
- Primary completionDec 2020
- Study completionJun 2021
Why it stopped: For financial reasons and speed of recruitment was much slower than expected, inclusions weren't resumed after it was suspended during COVID-19 confinment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck JEGOUX, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892487
- Sponsor's protocol ID
- 35RC14_9786_RORC
- Acronym
- RORC
- Status last verified
- Nov 2023
- First submitted
- 29 Aug 2016
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02892487
- Acronym / sponsor ID
- RORC / 35RC14_9786_RORC
- Conditions
- Cancer of Head and Neck
- Keywords
- Quality of life, Radiotherapy, Dysphagia, Oral cavity, Oropharynx, Hypopharynx, Larynx, Swallowing rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For financial reasons and speed of recruitment was much slower than expected, inclusions weren't resumed after it was suspended during COVID-19 confinment.
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 9 Dec 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 8 Sep 2016 (estimated)
- 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.
Toxicity and mainly dysphagia have increased in head and neck cancers as chemoradiation indications have risen over the last decade, leading to a significant loss of quality of life for patients. Recently, many retrospective studies and two evidence-based and systematic reviews on strategies to reduce radiation-induced dysphagia have suggested a trend toward benefit for a preventive swallowing exercise program.
The main hypothesis of this study is that an early active swallowing therapy can improve the Quality of Life (QoL) of patients treated by radiotherapy for head and neck cancer.
The study will be a randomized controlled, open-label, multicentric phase III clinical trial comparing early active swallowing therapy versus non specific swallowing management (usual care).
Detailed description
Patients in both groups will receive dietary and postural advice from the treating physician. Patients in the experimental group will be treated with an early active swallowing therapy including a consultation with a speech and language therapist twice a week and a detailed program of swallowing auto-exercises twice a day, from the start to one month after the end of radiotherapy. All speech therapists will be given precise guidelines based on the current state of the art and knowledge. All patients will be analyzed in intent-to-treat.
Two ancillary studies will complete this global concept of the evaluation and prediction of severe alteration of Quality of Life (QoL) and Dysphagia.
- A first study will evaluate videoradioscopy. Its objectives are to evaluate the ability of videoradioscopy at 3 months to predict poor QoL at 6 and 12 months, to identify videoradioscopic predictors of severe dysphagia, asymptomatic aspirations, cricopharyngeal stenoses and active swallowing rehabilitation efficiency. Each patient of both arms of the main study will undergo a videoradioscopy before the beginning of the radiation delivery (baseline evaluation), and at 3 and at 12 months. Data analysis will be centralized and will concern: APS (Aspiration and Penetration Scale) score, residue, Defective Laryngeal elevation, pharyngoesophageal sphincter dysfunction. Data will be correlated to the parameters of the main study in order to establish predictive models.
- A second ancillary study will evaluate the dose-volume histograms of radiotherapy. The objectives are to identify predictors of dysphagia and of active swallowing rehabilitation efficiency, and to establish "2D" and "3D" predictive models of dysphagia. Imaging and dosimetric data (IMRT (Intensity Modified RadioTherapy) planning) and dose-volume histogram will be collected from the patients of the main clinical trial. Analysis will be centralized. Data will be correlated to the parameters of the main study in order to establish predictive models.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early active swallowing therapy | Experimental | Other: Swallowing therapy |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient treated for histologically proven head and neck cancer (oral cavity, oropharynx, or hypopharynx cancer) of stages I-IV or larynx cancer of stages II-IV, all histologic type, without distant metastasis
- Indication of curative radiotherapy alone or associated to chemotherapy or targeted therapy, without planned surgery
- WHO (World Health Organization) Performance Status 0, 1 or 2
- Sufficient cognitive capacities to complete a QoL questionnaire (evaluation by the physician at inclusion)
- Written informed consent
Key exclusion criteria (5 listed)
- Previous radiotherapy or surgery of the upper aerodigestive tract
- Cancer of paranasal sinuses or nasopharynx or skull base
- Medical history of nervous system disease associated to significant sequelae in terms of dysphagia
- Pregnant or breast-feeding woman
- Patient under guardianship, trusteeship or judicial protection
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 |
|---|---|---|
| Swallowing therapyPatients will undergo active swallowing therapy with a speech and language therapist (twice a week) combined to a detailed program of swallowing auto-exercises (twice a day) from start of radiotherapy to one month after the end. | Other | Early active swallowing therapy |
Primary outcome
Proportion of patients experiencing a clinically relevant improvement defined as a decrease of at least 10 points of the score HNSW ( 6 months after radiotherapy compared with the score before radiotherapy
Time frame: 6 months after radiotherapy
HNSW = Head and Neck Swallowing Questionnaire
13 secondary outcomes
EORTC QLQ-C30 score
Time frame: Baseline, 3, 6 and 12 months after radiotherapy
EORTC H&N35 score
Time frame: Baseline, 3, 6 and 12 months after radiotherapy
MFI-20 score
Time frame: Baseline, 3, 6 and 12 months after radiotherapy
Body Mass index (BMI)
Time frame: Baseline, 3, 6 and 12 months after radiotherapy
Functional Oral Intake Scale (FOIS)
Time frame: Baseline, 3, 6 and 12 months after radiotherapy
Overall duration of enteral nutrition
Time frame: 12 months after radiotherapy
Total treatment duration
Time frame: 12 months after radiotherapy
Number of treatment interruptions
Time frame: 12 months after radiotherapy
Number of patients with adverse events
Time frame: End of radiotherapy (an average of 2 months after baseline), 1, 3, 6 and 12 months after radiotherapy
Swallowing specific Quality of Life (SWAL-QOL) score
Time frame: Baseline, 3, 6 and 12 months after radiotherapy
Number of patients with aspiration and penetration determined by APS (Aspiration and Penetration Scale) scoring
Time frame: Baseline, 3, 6 and 12 months after radiotherapy
Rate of global survival
Time frame: 12 months after radiotherapy
Rate of survival without recurrence
Time frame: 12 months after radiotherapy
Results and safety
The study was stopped early (reason given: For financial reasons and speed of recruitment was much slower than expected, inclusions weren't resumed after it was suspended during COVID-19 confinment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- 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. This study is not recruiting at the moment.
Franck JEGOUX principal investigator
Rennes University Hospital
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swallowing therapy in people with Cancer of Head and Neck, run by Rennes University Hospital at 21 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
The study was stopped early (reason given: For financial reasons and speed of recruitment was much slower than expected, inclusions weren't resumed after it was suspended during COVID-19 confinment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients experiencing a clinically relevant improvement defined as a decrease of at least 10 points of the score HNSW ( 6 months after radiotherapy compared with the score before radiotherapy (time frame: 6 months after radiotherapy). 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 18 Nov 2023.