Intervention Study on Life Style and Microbiota in Prostate Cancer Patients Undergoing Radiotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 311
- 试验地点
- 2
- 主要终点
- Change in adherence to a healthy lifestyle score
研究概览
简要总结
Microstyle study aims to evaluate the effect of a 6-month intervention in a group of prostate cancer patients undergoing radiotherapy. Intervention is designed to control side effects and to improve adherence to a healthy lifestyle (diet and increase level of physical activity and decreased sedentary time) measured by the change in adherence to a healthy lifestyle score. The impact of the intervention on toxicity and gastrointestinal symptomatology will be measured by a mediation framework analysis. This approach allows investigating how microbiome may mediate effect of treatment. It will be also assessed the change in microbiome in relation to the change in cytokines/ adipokines in association with early and late toxicity.
详细描述
MicroStyle study is a randomized two-arm crossover clinical trial. Study participants will be recruited among men undergoing radiotherapy (RT) in two centers (Milan and Naples). The study will be conducted over a three-year period, during which patients will receive a 6-month intervention and will be followed for other 6 months. The crossover design is used to reduce drop-out and to offer all patients the same opportunities, and also to evaluate the effect of the intervention after 6-month from RT when patients should have recreated a healthier microbiome and have less treatment side effects.
Three hundred patients will be enrolled over the study period and randomized in two arms: Intervention Group (IG) and Control Group (CG). Participants allocated to the IG will meet a dietitian and a physiotherapist before RT to receive personalized diet and exercise recommendations, according to their health status, to improve overall lifestyle and reduce side effects (bowel and/or urinary problems). The dietitian will give indication to limit the gastrointestinal side effects reducing consumption of foods rich in fiber, lactose and simple sugars, and the physiotherapist will set individualized goals based on capabilities, lifestyle pattern and preferences to increase physical activity and to reduce sedentary time. Moreover, the physiotherapist will provide specific indication to improve genitourinary health to reduce urinary incontinence that follows prostate treatments, erectile dysfunction and pelvic pain due to muscle spasm. All participants will be given a pedometer device (steps counter) in order to monitor and interfere (in the intervention group) with participants' physical activity and sedentary time. Participants included in the CG will receive at baseline general advice and materials available for patients undergoing RT. According to the crossover design, the CG will cross to the intervention as proposed for the IG, after the initial 6 months period.
Microstyle study foresee a 6-month intervention followed by 6-months of follow-up, over a period of 12 months for the intervention group (IG) while the control group (CG) will start the intervention 6 months after RT and they will follow-up for other 6 months over a period of 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •men aged 18 or older
- •candidates for a prostate curative treatment with RT (which includes exclusive RT +/-hormone therapy, surgery followed by RT +/- hormone therapy) AND
- •good performance status (ECOG < 2) AND
- •written informed consent obtained AND
- •willing to be randomized to either group, AND
- •willing to wear the wrist-based activity monitor during the 6-month study period.
排除标准
- •BMI <18.5 AND
- •extra pelvic lymph node involvement or metastasis and severe medical condition(s) that would prevent optimal participation in the physical activities prescribed AND
- •Malnutrition Universal Screening Tool (MUST) ≥
- •It considers body mass index, weight change and acute disease effect equally and determines a malnutrition risk score. A score ≥2 identify a patient at high risk of malnutrition AND
- •investigator does not approve participation in the study in case of severe clinical condition that would prevent optimal participation in the physical activities prescribed; any other severe medical condition or advanced age impeding the patient to adhere at the planned study follow-up period.
研究组 & 干预措施
Intervention group (IG)
Participants randomized to the IG will be offered an individualized counseling during cancer treatments that includes both a dietary and physical activity suggestions to control side effects, to cope with feelings of anxiety or depression and to improve quality of life.
干预措施: INTERVENTION GROUP (Procedure)
Control group (CG)
Participants included in the CG will receive at baseline general advice and materials available for patients undergoing RT. According to the crossover design, the CG will cross to the intervention as proposed for the IG, after the initial 6-month period.
结局指标
主要结局
Change in adherence to a healthy lifestyle score
时间窗: It will be assessed at the end of the 6-month intervention
The score will be computed using BMI, level of physical activity and food consumptions according the standardized system based on the World Cancer Research Fund (WCRF) and the American Institute for Cancer Research (AICR) recommendations (Shams-White et al, 2019). The score will range from 0 (minimal adherence) to 7 (maximal adherence).
次要结局
- Change in Dietary intake(6-month - up to 30 days - 12-month and 18-month (only for the CG))
- The effects of the interventions on serum biomarkers(6-month - 12-month and 18-month (only for the CG))
- Change in body composition(6-month - up to 30 days - 12-month and 18-month (only for the CG))
- Change in quality of Life(6-month - 12-month and 18-month (only for the CG))
- Change in acute and late toxicity(6-month - up to 30 days - 12-month and 18-month (only for the CG))
- change in the level of physical activity(6-month and 12-month (only for the CG))