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Health Oriented Protocol for Epidermal Radiodermatitis

Study acronym: HOPE
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Mar 31, 2026 → Mar 31, 2027
See other at-risk trials from Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Mar 31, 2026 to Mar 31, 2027 Show 6 more changesShow less
    • Recruitment opened
    • Study completion pushed from Sep 30, 2026 to Mar 31, 2027
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2025 to Sep 15, 2025
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 4 of 4 entries
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Radiation therapy is a standard treatment for malignant tumors of the head and neck and pelvic regions, used alone or in combination with chemotherapy. While effective, it is often associated with adverse effects that can impact patient outcomes. Among the most frequent toxicities is radiation-induced dermatitis (RID), affecting up to 95% of patients. These skin reactions, ranging in severity, may compromise quality of life and lead to treatment interruptions.The severity of RID is influenced by both intrinsic and extrinsic factors. Intrinsic factors include age, sex, ethnicity, nutritional status, and comorbidities such as diabetes or systemic inflammation. Extrinsic factors include the radiation technique, total dose, treated volume, and presence of infections. These variables require close monitoring to reduce complications.Radiation damages the skin and underlying tissues, causing xerosis, pigmentation changes, loss of elasticity, fibrosis, and varying degrees of dermatitis. Effective prevention starts with patient education and skincare support throughout treatment to reduce incidence and severity.In Italy, head and neck cancers, though less common than other malignancies, present a significant clinical burden. Laryngeal cancer accounts for around 5,000 new cases annually. Oral cavity, pharyngeal, and thyroid tumors also have notable incidence and require complex treatments such as (chemo)radiotherapy, increasing the risk of RID.RID represents not only a clinical issue but also a psychological and functional challenge. Pain, emotional distress, and reduced autonomy are key aspects affecting patients' overall wellbeing. A multidimensional approach that integrates clinical care and psychosocial support is essential.This study aims to investigate the relationship between RID severity, pain, psychological distress, and functional autonomy during radiotherapy or chemoradiotherapy, identifying predictors of severe toxicity and guiding personalized supportive care.
Trial Details
NCT Number NCT07129525
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions
(from sponsor)
Head and Neck Cancer, Pelvic Cancer, Radiation Skin Injury, Gynecologic Cancer, Radiotherapy Side Effect
Related terms Head and Neck Neoplasms, Pelvic Neoplasms, Radiation Injuries
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov