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Идёт набор NCT07574671

Impact of Ketogenic Diet on Tumor Microenvironment in Patients With Breast Cancer

Без фазы С лечением Breast Cancer

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: Ketogenic diet.
Кому может быть актуально
Состояния в реестре: Breast Cancer. 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

This study is testing the effects of a ketogenic diet on patients with early stage breast cancer. Participants will keep to a ketogenic diet for 3 weeks prior to surgery.

Подробное описание

After screening for eligibility participants will meet with a dietitian who will provide education on a ketogenic diet (KD) along with additional educational material. Patients will adhere to a ketogenic diet for 3 weeks. Serum glucose and ketones will be measured by patients daily to assess adherence to KD. Patients will also keep a daily diary that will note food intake along with physical activity.

Вмешательства

  • Другое Ketogenic diet
    The ketogenic diet will be comprised of a low carbohydrate, high fat diet.

Первичные конечные точки

  • Change in tumor immune microenvironment [Срок оценки: Baseline to 3 weeks]
Вторичные конечные точки (3)
  • ketone level [Срок оценки: Baseline to 3 weeks]
  • EORTC QLQ-30 (European Organization for Research and Treatment of Cancer) QLQ-30 Quality of life Questionnaire version 3) [Срок оценки: Baseline to 3 weeks]
  • Fact B (The Functional Assessment of Cancer Therapy - Breast) [Срок оценки: Baseline to 3 weeks]

Критерии участия

Критерии включения

  • Be willing and able to provide consent for the study
  • Age ≥ 18 on the day consent is obtained
  • Eastern Cooperative Oncology Group (ECOG) score ≤ 2
  • Patients must be postmenopausal the time of study entry
  • Stage I or II breast cancer using Tumor, Nodes and Metastasis (TNM) stage groups per American Joint Committee on Cancer (AJCC) 8th edition
  • Plan for upfront breast surgery with mastectomy or partial mastectomy and does not require pre-operative systemic therapy per standard of care
  • Must have tissue available from initial breast biopsy performed per standard of care
  • have the ability in the opinion of the investigator to adhere to a ketogenic diet and comply with study requirements such as ability to participate in telemedicine, utilize apps on a smart device, measure glucose/ketones at home, accurately log food intake and exercise, prepare food that is in line with ketogenic diet

Критерии исключения

  • Clinical indication for neoadjuvant therapy
  • Partial mastectomy or mastectomy planned for less than 3 weeks from study entry
  • Inability to comply with ketogenic diet
  • Consistent use of ketogenic diet within past 3 months
  • Participation in another diet program during study period
  • Nonepithelial breast malignancy such as sarcoma or lymphoma
  • Body Mass Index < 18.5
  • Comorbidities and/or active or ongoing illness that in the opinion of the investigator will limit patient's ability to safely participate in study
  • Type I diabetes
  • Use of insulin or other oral hypoglycemic drugs for diabetes
  • Has had any of the following within the past 6 months
  • Myocardial infarction or unstable angina
  • Ventricular arrythmia
  • Acute decompensated heart failure
  • Cerebrovascular accident
  • Hypertensive emergency
  • Uncontrolled hypertension despite antihypertensive use
  • End-stage renal, liver, or cardiac disease
  • genetic disorders that affect lipid metabolism (example: pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, beta-oxidation defects, among others)
  • G6PD (glucose-6-phosphate dehydrogenase) deficiency
  • Malabsorption syndromes (such as but not limited to inflammatory bowel disease, history of gastric sleeve, prior bowel resection)
  • History of recurrent kidney stones or predisposition to kidney stones
  • Triglycerides ≥ 500
  • Has known psychiatric or substance use disorders that would interfere with participation in the study

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
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Mays Cancer Center, UT Health San Antonio — San Antonio

Идентификаторы

NCT: NCT07574671 · CTMS# 25-0144

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗