Идёт набор NCT06999785

Assessment of the Impact of Increased Production of Reactive Oxygen Species Produced During Repeated Sessions of Hyperbaric Oxygen Therapy in Patients Undergoing Radiotherapy for Neoplasia, on the Occurrence of DNA Damage

Без фазы С лечением Hyperbaric Oxygen Genotoxicity Malignancy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Blood test.
Кому может быть актуально: Состояния в реестре: Hyperbaric Oxygen, Genotoxicity, Malignancy. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Hyperbaric Oxygen Therapy (HBOT) is a treatment involving the administration of oxygen at pressures higher than atmospheric pressure, with numerous potential indications such as radiation-induced tissue damage, chronic wounds, and more. HBOT significantly increases the amount of dissolved oxygen in tissues, thereby promoting wound healing. However, this "hyperoxygenation" may also exert toxic effects, particularly through the production of reactive oxygen species (ROS), which can induce DNA damage and potentially promote mutagenesis, thereby increasing long-term neoplastic risk. A single HBOT session is associated with a significant increase in ROS production, which may persist for up to 48 hours post-exposure, and is also linked to DNA damage. DNA repair is typically a rapid process, with the activation of protective mechanisms. The effects of repeated HBOT sessions remain a matter of debate. Reported outcomes range from attenuation of genotoxicity, to exacerbation of DNA damage, or no effect at all (8). In patients with cancer or comorbidities associated with impaired DNA repair capacity, repeated HBOT could be more detrimental, potentially increasing genotoxic effects and cancer risk. This increased oxygen susceptibility in cancer patients has already been observed in normobaric conditions during abdominal surgery, where hyperoxygenation strategies were associated with increased mortality in this subgroup. A potential pro-carcinogenic effect of HBOT in cancer patients has also been suggested in some case series, though not confirmed by larger studies. Current literature on HBOT safety remains generally reassuring; however, the possibility of DNA damage and its potential long-term genotoxic consequences cannot be entirely excluded. This question is of particular importance given that many primary indications for HBOT involve patients with a history of malignancy or active cancer

Вмешательства

Биопрепарат Blood test
a blood test before and after the first oxygen therapy session, as well as after the last session

Первичные конечные точки

Correlation between hyperbaric oxygen therapy and DNA damages [Срок оценки: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)]

Вторичные конечные точки (3)

reactive oxygen derivatives formation [Срок оценки: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)]
reactive oxygen derivatives formation [Срок оценки: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)]
Correlation between DNA damage and post-radic wound healing [Срок оценки: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)]

Критерии участия

Критерии включения

Adults (≥18 years old)
Having signed an informed consent form
Affiliated with or beneficiary of a national health insurance system
Admitted to the hyperbaric medicine department for HBOT treatment
Either for a complication related to prior radiotherapy (administered for an underlying neoplastic disease), such as:

Radiation cystitis Radiation proctitis / enteritis Radiation dermatitis Mandibular osteoradionecrosis Or for another indication, without any underlying neoplastic disease