Quality of Life Assessment of Radiotherapy in Recurrent Head and Neck Cancer
The purpose of this study is to examine the uses of a mobile health-based assessment and symptom monitoring platform.
Conditions:
🦠 Head and Neck Cancer
🗓️ Study Start (Actual) 30 August 2024
🗓️ Primary Completion (Estimated) 30 August 2025
✅ Study Completion (Estimated) 30 August 2026
👥 Enrollment (Estimated) 15
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Oklahoma City, Oklahoma, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age 18 years and older
    • * Written informed consent and any locally-required authorization obtained from the patients prior to performing any protocol-related procedures, including screening evaluations
    • * Pathologically (histologically or cytologically) proven diagnosis of cancer of the head and neck (nasopharynx, oral cavity, oropharynx, hypopharynx, larynx, or unknown primary)
    • * Locally recurrent or metastatic HNC not deemed amenable to curative-intent salvage therapy, in whom at least six months have passed since their prior RT, if received
    • * Must have evaluable lesion per RECIST v1.1
    • * Patients agree to provide their smoking history prior to registration
    • * ECOG performance status of 0-2

    Exclusion Criteria:

    • * Prior radiotherapy to the region of the study cancer within less than 6 months
    • * Patients who have received prior radiation therapy and who, in the opinion of the treating radiation oncologist, cannot be reirradiated safely without excess risk of severe toxicity given prior radiation dose to critical structures.
    • * Patients with known contraindications to radiotherapy, including inherited syndromes associated with hypersensitivity to ionizing radiation (e.g., Ataxia-Telangiectasia, Nijmegen Breakage Syndrome)
    • * Female patients who are pregnant
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 April 2023
  • First Submitted that Met QC Criteria 28 April 2023
  • First Posted 9 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 June 2024
  • Last Update Posted 11 June 2024
  • Last Verified June 2024