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Cancer of OropharynxDASRTNCT03448341

Dysphagia Assessment After Swallowing Sparing RadioTherapy

An observational study of Cancer of Oropharynx and Cancer of Nasopharynx, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To prospectively assess post-radiation late dysphagia by using MDADI questionnaire (deglutition-related quality of life) and objective instrumental assessment by means of Fiberoptic Endoscopic Evaluation of Swallowing (FEES) and Videofluoroscopy (VFS) in patients affected by nasopharynx and oropharynx cancers… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cancer of Oropharynx, Cancer of Nasopharynx
How many people
74 participants
Where
1 siteItaly
Study dates
16 Jul 2016to 31 Jan 2022
Phase
Observational
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with Locally Advanced Oropharynx or Nasopharynx cancer, that can be treated with an exclusive chemo-radiotherapy.

Who may be able to join

  • Histological diagnosis of squamous cell carcinoma or undifferentiated carcinoma of the otoiatric district
  • Subsider of the primitive: (Nasopharynx Stage II and III); Oropharynx Stage III-IVA
  • ECOG Status 0-2
  • Chemiotherapy concomitant at radiotherapy (Cisplatin 100mg / m2 every 21 days or 40mg / m2 weekly)

Who cannot join

  • Histological diagnosis different from squamous or undifferentiated cell carcinoma
  • Subsider of the primitive different from Nasopharynx, Oropharynx
  • Nasopharynx Stage IV; Oropharynx Stage IVB and C
  • ECOG ≥3
  • Prior induction chemotherapy
  • Prior oncological surgery on the otoiatric district
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  • Prior radiation treatment on the otoiatric district
  • Concomitant diseases that could modify the swallowing function (ex Amyotrophic Lateral Sclerosis or Multiple Sclerosis)
  • A history of excessive use of benzodiazepines or similar (ex patients in psychiatric therapy) or eostroesophageal reflux resistant at medical therapy

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56100

Other trials in Italy

About this study

Official title: Clinical and Instrumental Evaluation of Late Dysphagia in Naso and Oropharynx Cancer After Swallowing-organs (SWOARs)-Sparing Chemo-IMRT

To prospectively assess post-radiation late dysphagia by using MDADI questionnaire (deglutition-related quality of life) and objective instrumental assessment by means of Fiberoptic Endoscopic Evaluation of Swallowing (FEES) and Videofluoroscopy (VFS) in patients affected by nasopharynx and oropharynx cancers candidates to radiochemotherapy. Radiotherapy is delivered by using Intensity and Modulated Technique (IMRT) with a planning dose optimization to the swallowing related structures (SWOARs-sparing IMRT).

The primary aim is to assess the variations of MDADI, FEES and VFS from baseline to 6 and 12 months after treatment.

The secondary aim is to correlate clinical and instrumental results as well as radiation dose received by the different swallowing related structures (SWOARs) to the variations of clinical (MDADI) and instrumental (FEES and VFS) scores.

Read the detailed description

The aim of the study is to prospectively investigate the impact of radiochemotherapy on both the deglution-related quality of life (QoL) by means of MDADI questionnaire and the swallowing function by means of Fiberoptic Endoscopic Evaluation of Swallowing (FEES) and Videofluoroscopy (VFS).

Radiotherapy All patients requiring bilateral neck irradiation will be considered.

The clinical target volumes (CTVs) is directly delineated by the radiation oncologist according to the guidelines of the Italian Association of Radiation Oncology-Head and Neck Working Group 27 and the corresponding planning target volumes (PTVs) is automatically created by uniform expansions of 0.3 cm.

Patients positioning is assessed by weekly cone beam CT (CBCT) and online correction to reduce systematic set-up errors.

The prescribed doses is 66 Gy at 2.2 Gy per fraction to the high risk gross volume PTV and 60-54 Gy at 2.0-1.8 Gy per fraction to the intermediate (optional) and low risk subclinical PTVs, respectively, delivered concomitantly in 30 daily fractions.

Eight different SWOARs are defined in each CT slice and included in IMRT planning objective functions: superior, middle and inferior constrictor muscle (SPCM, MPCM and IPCM), supraglottic larynx (SL), glottis larynx (GL), cricopharyngeus muscle (CPM) and cervical oesophagus (CE). Thereafter, the mean dose received by each swallowing structures as well as by parotid glands and oral cavity will be recorded.

In the IMRT optimisation cost function, target coverage replace sparing of any SWOARs, parotid glands and oral cavity, but the spinal cord.

The IMRT plans set target prescription goals and spinal cord maximum dose (Dmax) as the highest priority, whereas SWOAR constraints are set as secondary.

Medical therapy

Chemotherapy is given weekly using Cisplatin 40 mg/mq for a maximum of 6 cycles or 100 mg/mq every 3 weeks during the 6-week RT course for a maximum of 3 cycles.

MDADI questionnaire

All the enrolled patients fill in the MDADI questionnaire at baseline and at 6 and 12 months after ChemoRT. The validated Italian version of MDADI is used. A MDADI score of at least 80 represents an "optimal" deglutition-related QoL, a score between 60 and 80 represents an "adequate" deglutition-related QoL, and a score less than 60 represents a "poor" deglutition-related QoL. A 10-point difference in the MDADI composite score is considered a minimal clinically important difference (MCID) in the deglutition-related QoL.

Fiberoptic Endoscopic Evaluation of Swallowing (FEES)

This exam is specifically used to evaluate the severity of post-swallowing pharyngeal residue according to Farneti pooling score (P-score), a reliable and validated tool that significantly predicts aspirations.

Videofluoroscopy (VFS)

This exam is specifically used to evaluate the pattern of penetration and aspiration based on the Penetration-Aspiration Scale (PAS)

Keywords
Radiotherapy, IMRT, Dysphagia, Oropharynx, Nasopharynx, FEES, VFS, Chemotherapy
Medical subject headings
Oropharyngeal Neoplasms, Nasopharyngeal Neoplasms, Deglutition Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the changes of deglutition-related quality of life by means of MDADI questionnaire from before to after radiochemotherapy

    All patients will be evaluated by using MDADI questionnaire at baseline and at 6 and 12 months after radiochemotherapy. The variations of MDADI questionnaire scores from before to after treatment will be analysed.

    Measured: Baseline, 6 and 12 months treatment

  2. To assess the changes of deglutition function by means of Fiberoptic Endoscopic Evaluation of Swallowing (FEES) from before to after radiochemotherapy

    All patients will be evaluated by using FEES at baseline and at 6 and 12 months after radiochemotherapy. The variations of FEES scores from before to after treatment will be analysed

    Measured: Before, 6 and 12 months after treatment

  3. To assess the changes of deglutition function by means of Videofluoroscopy (VFS) from before to after radiochemotherapy

    All patients will be evaluated by using VFS at baseline and at 6 and 12 months after radiochemotherapy. The variations of VFS scores from before to after treatment will be analysed

    Measured: Before, 6 and 12 months after treatment

Secondary outcomes (2)

  1. To correlate MDADI score (deglutition-related quality of life) changes with FEES and VFS score (deglutition function) changes from before to after treatment

    The correlation between clinical (MDADI) and instrumental (FEES and VFS) scores will be performed according to the following dichotomy:

    MDADI >80 vs MDADI <80 (optimal vs adequate or poor) FEES P-score 4-7 vs 8-11 (no/mild dysphagia vs adequate/severe dysphagia) VFS PAS score 1-2 vs 3-8 (safe deglutition vs penetration or aspiration)

    Measured: Before, 6 and 12 months after treatment

  2. To correlate radiation dose features received by the different swallowing related structures (SWOARs) to the changes of MDADI, FEES and VFS scores from before to after treatment by using a Machine Learning Methodology

    Correlation between MDADI, FEES and VFS score changes with radiation dose received by the SWOARs will be performed according to the following criteria.

    The following radiation dose features (Gy) will be extracted for each SWOAR from dose volume hystograms (DVHs): V35, V45, V55, V65, minimum dose (Dmin), maximum dose (Dmax), mean dose (Dmean) and the dose corresponding to the absolute maximum of the differential DVH, hence the modal dose (Dmp).

    The abovementioned dose features will be correlated with the following outcome measures and according to the following stratification criteria:

    MDADI >80 vs MDADI <80 (optimal vs adequate or poor) FEES P-score 4-7 vs 8-11 (no/mild dysphagia vs adequate/severe dysphagia) VFS PAS score 1-2 vs 3-8 (safe deglutition vs penetration or aspiration)

    Measured: At baseline and at 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2018
  2. Study start16 Jul 2016
  3. Primary completion1 May 2020
  4. Study completion31 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03448341
Sponsor's protocol ID
1112
Acronym
DASRT
Status last verified
Sep 2022
First submitted
22 Feb 2018
Last updated
15 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer of Oropharynx and Cancer of Nasopharynx, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.

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 4 inclusion and 9 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: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To assess the changes of deglutition-related quality of life by means of MDADI questionnaire from before to after radiochemotherapy (time frame: Baseline, 6 and 12 months treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03448341.

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 15 Sep 2022.

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