Use of a Fasting Mimicking Diet in Patients Undergoing Chemotherapy for Gynecologic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Rate of Adherence
研究概览
简要总结
This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.
详细描述
Since chemotherapy remains one of the primary treatment modalities for gynecologic malignancies, there is increasing interest in non-pharmacological methods of reducing chemotherapy side effects in cancer patients. Our goal is to increase the knowledge surrounding lifestyle modifications, specifically the fasting mimicking diet, on chemotherapy-related side effects, which may be more acceptable to patients than a previously studied water-only fasting diet. To expand this knowledge, The investigators will focus on patients undergoing chemotherapy for gynecologic malignancies. These patients will be assigned to no dietary restriction (control group) or a 5-day fasting mimicking diet (FMD by L-Nutra) for three days prior to, the day of, and one day following chemotherapy treatments (treatment group). The investigators aim to evaluate the feasibility of a fasting mimicking diet in addition to its metabolic effects on the body, patient reported side effects, patient quality of life, deviations or delays in treatment plans, and hospital admissions. Our hypothesis is that a fasting mimicking diet will significantly decrease chemotherapy-related side effects while providing good quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Outcomes Assessor
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 35-70 years old (both inclusive)
- •Biopsy proven gynecologic malignancy
- •Scheduled to or currently undergoing chemotherapy, with a minimum of 6 cycles remaining
- •BMI greater than or equal to 18.5
- •Adequate renal function (serum creatinine less than 1.5 times the upper limit of normal)
- •Willing to adhere to a 5-day fasting mimicking diet
排除标准
- •Pregnant or nursing mothers
- •Prisoners
- •Patients with diabetes or history of hypoglycemia
- •Taking daily medications that cannot be safely taken without food
- •History of significant or unstable cardiac disease such as congestive heart failure or history of myocardial infarction, stroke or pulmonary embolism within the last 3 months, renal failure, history of - eating disorder, dementia, psychosis, impaired physical mobility.
- •Significant medical comorbidity that would be dangerous with a fasting mimicking diet.
- •Any known or suspected food allergies that overlap with the FMD/Transitional diet by L-Nutra meal kit ingredients.
研究组 & 干预措施
FMD
In addition to the standard care, subject will consume a 5-day fasting mimicking diet.
干预措施: Fasting Mimicking Diet (Other)
FMD
In addition to the standard care, subject will consume a 5-day fasting mimicking diet.
干预措施: Chemotherapy (Drug)
Control
Subjects will receive the standard care and no dietary changes.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Rate of Adherence
时间窗: Week 0-21
The ability to adhere to a 5-day fasting mimicking diet.
Quality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire
时间窗: Week 0-21
The NFOSI-18 questionnaire allows for a uniform assessment of health-related quality of life through an 18-question (5-point Likert-type scale) survey including four subscale domains: Disease-Related Symptoms - Physical, Disease-Related Symptoms - Emotional, Treatment Side Effects. and Function/Well-Being. To calculate subscale scores, sum the item scores within each domain. Higher subscale scores indicate more significant symptom burden or impact. The total score is obtained by summing all 18 item scores. A higher total score reflects more severe symptoms overall.
次要结局
- Change in Body Weight(Week 0, Week12, Week 21)
- Change in Body Composition(Week 0, Week12, Week 21)
- Change in HbA1c(Week 0, Week 21)
- Change in Insulin Like Growth Factor 1 (IGF-1) Concentration(Week 0, Week 21)
- Change in Fasting Insulin Concentration(Week 0, Week 21)
- Change in Fasting Glucose Concentration(Week 0, Week 21)
- Change in High-sensitivity C reactive protein Concentration(Week 0, Week 21)
- Change in Leptin Concentration(Week 0, Week 21)
- Change in planned chemotherapy regimen(Week 0-21)
- Number of Hospitalization Days(Week 0-21)
- Rate of Chemotherapy Side Effects(Week 0-21)