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Comparing The Effectiveness of Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer

PRO-ACTIVE: Comparing The Effectiveness of Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer

  • Clinical Trial Information

    Trial Contact: Manchola-Orozco, Carolina

    Trial Phone: 321.841.7293

  • IRB No: 20.012.02

    Protocol Abbrev: PRO-ACTIVE

    Principal Investigator: Jennifer Lynn Root Mayer, MD

    Age Group: Adult

    Secondary Protocol No: PRO-ACTIVE

    Treatment: ARM: Active Comparator: RE-ACTIVE Reactive intervention started promptly if/when dysphagia is identified (RE-ACTIVE) INTERVENTION/TREATMENT: Behavioral: RE-ACTIVE Reactive intervention started promptly if/when dysphagia is identified

    ClinicalTrials.gov ID: NCT03455608

  • Objective

    The primary aim of the PRO-ACTIVE trial is to compare the effectiveness of PRO-ACTIVE versus RE-ACTIVE swallowing interventions among patients with HNC planned to undergo RT. We hypothesize that the combined PRO-ACTIVE therapies are more effective than RE-ACTIVE therapy; and, if so, that more intensive PRO-ACTIVE (EAT + EXERCISE) is superior to less intensive PRO-ACTIVE (EAT). Effectiveness will be measured based on reduced duration of feeding tube dependency as the primary endpoint, an outcome valued equally by patients, caregivers and clinicians.

  • Key Eligibility

    Inclusion Criteria:

    •  Adults ≥ 18 years of age diagnosed with head and neck malignancy;
    •  RT treatment planned for curative intent;
    •  Dispositioned to receive external beam radiotherapy dose ≥60 gray to bilateral fields at participating institution;
    •  Sufficient fluency in written English, French, Spanish or Simplified Chinese to be able to complete the study patient reported outcome questionnaires



    Exclusion Criteria:

    •  Distant metastasis at enrollment; or
    •  Prior or planned total laryngectomy; or
    •  Moderate/severe dysphagia at enrollment per baseline videofluoroscopy DIGEST grade ≥2 (as graded per central laboratory review)
    •  Previously seen by speech language pathologist for swallowing therapy for the current head and neck cancer
    •  Diagnosis of second primary non-head and neck cancers in the thorax or the central nervous system at enrollment
    •  Head and neck radiotherapy for thyroid or cutaneous/skin primary tumors, regardless of neck fields