Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer (RORC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02892487
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief 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. 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).


Condition or disease Intervention/treatment Phase
Cancer of Head and Neck Other: Swallowing therapy Not Applicable

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.

  1. 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.
  2. 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer
Actual Study Start Date : December 9, 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early active swallowing therapy Other: Swallowing therapy
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.

No Intervention: Usual care



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. EORTC QLQ-C30 score [ Time Frame: Baseline, 3, 6 and 12 months after radiotherapy ]
    EORTC QLQ = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire

  2. EORTC H&N35 score [ Time Frame: Baseline, 3, 6 and 12 months after radiotherapy ]
    EORTC H&N = European Organisation for Research and Treatment of Cancer Head and Neck questionnaire

  3. MFI-20 score [ Time Frame: Baseline, 3, 6 and 12 months after radiotherapy ]
    MFI = Multidimensional Fatigue Inventory

  4. Body Mass index (BMI) [ Time Frame: Baseline, 3, 6 and 12 months after radiotherapy ]
    in kg/m^2

  5. Functional Oral Intake Scale (FOIS) [ Time Frame: Baseline, 3, 6 and 12 months after radiotherapy ]
  6. Overall duration of enteral nutrition [ Time Frame: 12 months after radiotherapy ]
  7. Total treatment duration [ Time Frame: 12 months after radiotherapy ]
  8. Number of treatment interruptions [ Time Frame: 12 months after radiotherapy ]
  9. 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 ]
  10. Swallowing specific Quality of Life (SWAL-QOL) score [ Time Frame: Baseline, 3, 6 and 12 months after radiotherapy ]
  11. 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 ]
  12. Rate of global survival [ Time Frame: 12 months after radiotherapy ]
  13. Rate of survival without recurrence [ Time Frame: 12 months after radiotherapy ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892487


Contacts
Layout table for location contacts
Contact: Claire FOUGEROU +33 (0)2 99 28 37 53 claire.fougerou@chu-rennes.fr

Locations
Show Show 21 study locations
Sponsors and Collaborators
Rennes University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Franck JEGOUX Rennes University Hospital
Layout table for additonal information
Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02892487    
Other Study ID Numbers: 35RC14_9786_RORC
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rennes University Hospital:
Quality of life
Radiotherapy
Dysphagia
Oral cavity
Oropharynx
Hypopharynx
Larynx
Swallowing rehabilitation
Toxicity
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms