Effect of Meal Timing During Adjuvant Treatment for 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: Time-restricted eating, Questionnaire Administration, Biospecimen Collection, Health coaching.
- Кому может быть актуально
- Состояния в реестре: 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Effect of Meal Timing During Adjuvant Treatment for Cancer: A Randomized Clinical Trial
Обзор
The goal of this clinical trial is to test meal-timing as a novel and sustainable interventional approach during cancer treatment to improve therapeutic response, patient well-being and long-term metabolic health. In alignment with these priorities, we propose to focus on patients with histologically or cytologically confirmed solid tumors treated with curative-intent surgical resection and planned initiation of systemic adjuvant therapy (chemotherapy, targeted therapy, immunotherapy, and/or radiation per standard of care). A promising strategy for improving the efficacy of anticancer treatments and reducing associated toxicities involves combining treatment with fasting regimens. In pre-clinical and clinical studies, various forms of fasting have been shown to induce tumor regression and improve long-term survival. According to the differential stress sensitization theory, fasting is thought to sensitize tumor cells to the cytotoxic effects of chemotherapy and radiation, while protecting healthy cells by increasing stress resistance. While healthy cells slow their growth and become more stress resistant in response to fasting, cancer cells cannot survive in nutrient-deficient environments; although the underlying mechanisms are not fully understood. However, extended water-only fasting can be challenging for patients and poses undue health risks. Intermittent fasting, and specifically time-restricted eating (TRE), may offer a viable alternative. TRE involves eating within a shorter window (e.g., 8 hours) and fasting for the remainder of the day but involves no other dietary restrictions. Because of its simplicity, TRE may be more sustainable than other fasting regimens. TRE also improves several cardio-metabolic endpoints, including insulin sensitivity, which may also be beneficial during anticancer treatments.
Подробное описание
Participants will be randomized to one of two groups:
1. Time-restricted eating (TRE) (8-hour daily eating period, starting 1-3 hours after waking up), OR 2. A control group defined as a ≥12-hour daily eating period.
Participants are assigned to either TRE (8-hour daily eating period, starting 1-3 hours after waking up) or a control group defined as a ≥12-hour daily eating period. Their randomized meal assignment arm begins no later than 1-2 week after they begin cancer treatment and ends at end of treatment (resection if indicated). This is a period of approximately 6 months.
During this time, participants will be asked to record the time they started and finished eating every day. Electronic reminders and weekly calls to the participants will be made by study staff who maintain records of patient's meal timing. Researchers will time the TRE schedules relative to sleep time (not time of day), which is a reasonable proxy for circadian time. The control group was designed to mimic typical eating habits in the U.S., as data from NHANES suggest that the median American eats over a 12.5-hour period each day. Aside from these general prescriptions, no set number of snacks, meals, or calories will be prescribed. Instead, researchers will measure how TRE affects self-reported mealtimes, meal frequency, and food intake through a combination of daily adherence surveys, 3-day food records and continuous glucose monitoring (CGM).
Participants will receive weekly one-on-one nutrition counseling during the first month and then monthly counseling sessions thereafter. Participants will complete questionnaires at intake and subsequent follow-up assessments. Blood and stool samples will also be collected from participants throughout the study.
Вмешательства
- Поведенческое Time-restricted eating
Participate in time-restricted eating plan - Другое Questionnaire Administration
Complete questionnaire - Процедура Biospecimen Collection
Undergo collection of blood and stool - Поведенческое Health coaching
Receive nutrition counseling
Первичные конечные точки
- Patient-reported treatment-related toxicities: Average weekly scores [Срок оценки: Assessed weekly from start of intervention through end of intervention (up to approximately 6 months)]
- Treatment Delivery: Relative dose intensity (RDI) [Срок оценки: At end of intervention (at approximately 6 months)]
- Treatment Delivery: Number of patients completing planned adjuvant therapy without unplanned dose reductions or delays [Срок оценки: At end of intervention (at approximately 6 monhts)]
Вторичные конечные точки (12)
- Clinician-reported CTCAE grade ≥3 toxicities [Срок оценки: Baseline through end of intervention (at approximately 6 months)]
- Clinician-reported Toxicity Index [Срок оценки: Baseline through end of intervention (at approximately 6 months)]
- Changes in quality of life (QOL): EORTC QLQ-C30 [Срок оценки: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- PROMIS Anxiety [Срок оценки: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- PROMIS Fatigue [Срок оценки: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- PROMIS Physical Function [Срок оценки: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- UCLA Loneliness Scale [Срок оценки: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- Munich Chronotype Questionnaire (MCTQ) [Срок оценки: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- Appetite Questionnaire [Срок оценки: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- Dutch Eating Behavior Questionnaire (DEBQ) [Срок оценки: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- Fasting Insulin [Срок оценки: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
Критерии участия
Критерии включения
- Age ≥18 years (no upper age limit)
- Any sex or gender
- Histologically or cytologically confirmed solid tumor treated with curative-intent surgical resection and planned initiation of systemic adjuvant therapy (chemotherapy, targeted therapy, immunotherapy, and/or radiation per standard of care)
- BMI ≥18.5 kg/m2
- Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions
Критерии исключения
- No plan for systemic adjuvant therapy after surgery
- Strictly adhering to a <10-hour eating window on most days
- Regular overnight shift work (≥1 night shift per week)
- Dependent on parenteral or enteral nutrition
- Pregnant or breastfeeding
- Active second malignancy requiring systemic therapy (exceptions: non-melanoma skin cancers or in situ cervical cancers adequately treated)
- Severe psychiatric, cognitive, or social conditions that would interfere with adherence to study procedures
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
- Cedars Sinai Medical Center (CSMC) — Los Angeles
Идентификаторы
NCT: NCT07524218 · RG1126131 · 1P50CA285275-01A1 · FHIRB21058