Novel Treatment of Radiation Associated Dysphagia With Statins

Официальное название

TRADstat: Novel Treatment of Radiation Associated Dysphagia With Statins

Обзор

The aim of this trial is to examine the feasibility, acceptability, and potential efficacy of a 12-month course of pravastatin as an antifibrotic agent for managing dysphagia (swallowing problems) in patients previously treated with radiotherapy for head and neck cancer (HNC). The purpose is to assess whether pravastatin, a medication approved in Australia for cholesterol management, can improve swallowing in people with long-term radiation-associated dysphagia following HNC treatment. The trial will recruit 48 patients, with an anticipated accrual period of approximately 6 months. Eligible patients will be identified from the Principal Investigator's current study, ERADICATE, or through referral by a radiation oncologist or speech pathologist diagnosing radiation-induced dysphagia. Participants will receive 40 mg of pravastatin daily for up to 12 months, with swallowing assessments conducted before, during, and after treatment.

Вмешательства

• Препарат Pravastatin 40 Mg Oral Tablet
  This trial will incorporate Pravastatin 40 mg as an off-label use for the treatment of radiation-associated dysphagia.

Первичные конечные точки

• Feasibility of a 12 month trial investigating the use of pravastatin to treat radiation-associated dysphagia [Срок оценки: From the start of pravastatin therapy to 6 months of follow up after the completion of 12 months of pravastatin therapy (total estimated time duration 18 months)]
• Preliminary evidence of efficacy of the pravastatin to treat radiation-associated dysphagia [Срок оценки: From enrolment to the end of 12 months of pravastatin use]

Вторичные конечные точки (3)

• Acceptability of trial methods and procedures and acceptability of pravastatin [Срок оценки: From the start of pravastatin therapy to 6 months of follow up after the completion of 12 months of pravastatin therapy (total estimated time duration 18 months)]
• Tolerability of pravastatin [Срок оценки: From the start of pravastatin therapy until the completion of 12 months of therapy]
• Safety of pravastatin use [Срок оценки: From the start of pravastatin therapy until the completion of 12 months of therapy]

Критерии участия

Критерии включения

• Patient has provided written informed consent using the TRADstat PICF
• Patients aged 18 years or older at screening
• Received curative intent (chemo)radiotherapy to the nasopharynx, oropharynx, hypopharynx or larynx at least 2 years prior to screening
• Moderate-severe RAD using validated cut-offs (PAS score > 3 and/or DIGEST grading ≥ 2), identified on a VFSS conducted within the last 12 months
• Adequate kidney function defined as estimated glomerular filtration rate (eGFR) ≥ 40 ml/min
• Adequate hepatic function defined as:

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than 2 times the upper normal limit (ULN)
• Bilirubin level at least 1.5 times lower than the ULN
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 (Appendix 1)

Критерии исключения

• Known hypersensitivity to pravastatin and/or any excipients
• Diagnosis of myasthenia (muscle weakness)
• History of head or neck surgery, other than excisional biopsy or post treatment neck dissection
• Known active malignancy
• Currently taking statin medication
• Currently taking prohibited medicines (long-term steroids or drugs listed under Section 8.4)
• History of severe heart failure; a history of muscle toxicity during previous treatments with fibrates or statins; a history of hereditary muscle diseases
• Known medical condition(s) that may impact swallowing function (e.g., stroke, neurological conditions, tracheostomy)
• Pregnant or breastfeeding

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Peter MacCallum Cancer Centre — Melbourne

Публикации

• Bourgier C, Auperin A, Rivera S, Boisselier P, Petit B, Lang P, Lassau N, Taourel P, Tetreau R, Azria D, Bourhis J, Deutsch E, Vozenin MC. Pravastatin Reverses Established Radiation-Induced Cutaneous and Subcutaneous Fibrosis in Patients With Head and Neck Cancer: Results of the Biology-Driven Phase 2 Clinical Trial Pravacur. Int J Radiat Oncol Biol Phys. 2019 Jun 1;104(2):365-373. doi: 10.1016/j. PMID 30776452

Идентификаторы

NCT: NCT07217938 · 121555

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗