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A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies

Без фазы С лечением Medical Oncology Integrative Oncology Medical Nutrition Therapy

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: Diet.
Кому может быть актуально
Состояния в реестре: Medical Oncology, Integrative Oncology, Medical Nutrition Therapy. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The main idea of this study is that a low protein diet may alter the environment surrounding the tumor, enhancing the body's immune response leading to greater anticancer effects of treatment. This study intends to use a low-protein diet as a tool to enhance the immune response generated by immune check point inhibitor treatments.

Подробное описание

This is a single center, randomized, open label study to assess the feasibility of a low-protein diet intervention in cancer patients who are receiving immunotherapies. Subjects will be randomized in a 1:1 ratio to either immunotherapy plus control diet arm (\~20% protein content) or immunotherapy plus intervention low-protein diet arm (10% protein content).

Вмешательства

  • Другое Diet
    Control diet consisting of 20% protein, intervention diet consisting of 10% protein

Первичные конечные точки

  • To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies. [Срок оценки: 4 Months]
  • To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies. [Срок оценки: 4 Months]
Вторичные конечные точки (9)
  • To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies [Срок оценки: 4 Months]
  • To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies [Срок оценки: 4 Months]
  • To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies [Срок оценки: 4 Months]
  • To assess the enrollment rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention [Срок оценки: 4 Months]
  • To assess the Drop-out rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention [Срок оценки: 4 Months]
  • To assess the safety and tolerability of the combination of immunotherapies and low-protein diet intervention [Срок оценки: 4 Months]
  • To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria [Срок оценки: 4 Months]
  • To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria [Срок оценки: 4 Months]
  • To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria [Срок оценки: 4 Months]

Критерии участия

Критерии включения

  • Histologically documented solid tumor malignancies which is amenable for immunotherapy treatment with immune checkpoint inhibitors (i.e. PD1, PD-L1, CTLA inhibitors) as single agents or in combination.
  • Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan of the chest, abdomen, and pelvis
  • Life expectancy of at least 6 months
  • Adults ≥ 18 years of age
  • Adequate hematologic, renal, and liver function as evidenced by the following:
  • White blood cell (WBC) ≥ 2,500 cells/μL
  • Absolute neutrophil count (ANC) ≥ 1,000 cells/μL
  • Platelet Count ≥ 100,000 cells/μL
  • Hemoglobin (HgB) ≥ 9.0 g/dL
  • Creatinine ≤ 2.0 mg/dL
  • Total bilirubin ≤ 2 x upper limit of normal (ULN)
  • Aspartate aminotransaminase (AST, SGOT) ≤ 2.5 x ULN
  • Alanine aminotransaminase (ALT, SGPT) ≤ 2.5 x ULN

Критерии исключения

  • • Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher
  • Treatment with any of the following medications or interventions within 28 days of registration:
  • Systemic corticosteroids; however, use of inhaled, intranasal, and topical steroids is acceptable.
  • High dose calcitriol \[1,25(OH)2VitD\] (i.e., > 7.0 μg/week)
  • A requirement for systemic immunosuppressive therapy for any reason
  • Any infection requiring parenteral antibiotic therapy or causing fever (temperature > 100.5°F or 38.1°C) within 1 week prior to registration
  • A known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT imaging
  • Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University at Buffalo / Great Lakes Cancer Care — Buffalo

Идентификаторы

NCT: NCT05356182 · STUDY00005755

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗