Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

Официальное название

A Pilot, Feasibility Study of Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

Обзор

This is a a pilot study to assess the feasibility of intermittent caloric restriction (plus a plant-enriched diet optionally) in prostate cancer patients receiving androgen deprivation therapy. Study feasibility measures will include enrollment rate, drop-out rate and compliance with diet measured by self-reports.

Вмешательства

• Другое Intermittent Fasting
  Dietary intervention

Первичные конечные точки

• Enrollment rate [Срок оценки: 3 years]
• Drop-out rate [Срок оценки: 3 years]

Вторичные конечные точки (2)

• Number of patients who achieve either partial or complete response by RECIST criteria on tumor imaging. [Срок оценки: 3 years]
• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [Срок оценки: 3 years]

Критерии участия

Критерии включения

• In order to be eligible for participation in this trial, the subject must:
• Be willing and able to provide written informed consent for the trial.
• Be male at birth and least 18 years of age on day of signing informed consent.
• Have measurable prostate cancer disease and be eligible for androgen deprivation therapy.
• Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
• Demonstrate adequate organ function (all screening labs should be performed within 10 days of treatment initiation).
• Subjects have archival tumor tissue available or are willing to undergo a baseline biopsy prior to treatment.
• Subjects must have a life expectancy of at least 6 months.

Критерии исключения

• Has an ECOG performance of 2 or higher.
• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the beginning of the treatment.
• Has a known additional malignancy that is progressing or requires active treatment.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Has a known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT/MRI imaging
• Has any other medical intervention or condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives.
• Is not willing and able to provide written informed consent for the trial.

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

США · 1 центр

• University at Buffalo/Great Lakes Cancer Center — Buffalo

Идентификаторы

NCT: NCT06172283 · STUDY00007635

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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