Dysphagia Assessment After Swallowing Sparing RadioTherapy
Condition: Cancer of Oropharynx; Cancer of Nasopharynx
MeSH terms: Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Deglutition Disorders
Study type: Observational

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 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.
    

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)
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Locally Advanced Oropharynx or Nasopharynx cancer, that can be treated with
        an exclusive chemo-radiotherapy.
      
Keywords: Radiotherapy; IMRT; Dysphagia; Oropharynx; Nasopharynx; FEES; VFS; Chemotherapy