Life style and interaction with microbiota in prostate cancer patients undergoing radiotherapy: study protocol for a randomized controlled trial

被引:4
作者
Gnagnarella, Patrizia [1 ]
Marvaso, Giulia [2 ,3 ]
Jereczek-Fossa, Barbara Alicja [2 ,3 ]
de Cobelli, Ottavio [3 ,4 ]
Simoncini, Maria Claudia [5 ]
Nevola Teixeira, Luiz Felipe [5 ]
Sabbatini, Annarita [6 ]
Pravettoni, Gabriella [3 ,7 ]
Johansson, Harriet [8 ]
Nezi, Luigi [9 ]
Muto, Paolo [10 ]
Borzillo, Valentina [10 ]
Celentano, Egidio [11 ]
Crispo, Anna [11 ]
Pinto, Monica [12 ]
Cavalcanti, Ernesta [13 ]
Gandini, Sara [9 ]
机构
[1] European Inst Oncol IRCSS, Div Epidemiol & Biostat, Milan, Italy
[2] European Inst Oncol IRCSS, Dept Radiat Oncol, Milan, Italy
[3] Univ Milan, Dept Oncol & Hemato Oncol, Milan, Italy
[4] European Inst Oncol IRCSS, Div Urol, Milan, Italy
[5] European Inst Oncol IRCSS, Physiotherapy Unit, Milan, Italy
[6] European Inst Oncol IRCSS, Dietet & Clin Nutr Unit, Milan, Italy
[7] European Inst Oncol IRCSS, Appl Res Div Cognit & Psychol Sci, Milan, Italy
[8] European Inst Oncol IRCSS, Div Canc Prevent & Genet, Milan, Italy
[9] European Inst Oncol IRCSS, Dept Expt Oncol, Milan, Italy
[10] Ist Nazl Tumori IRCCS Fdn G Pascale, Dept Radiat Oncol, Naples, Italy
[11] Ist Nazl Tumori IRCCS Fdn G Pascale, Epidemiol & Biostat Unit, Naples, Italy
[12] Ist Nazl Tumori IRCCS Fdn G Pascale, Rehabil Med Unit, Strateg Hlth Serv Dept, Naples, Italy
[13] Ist Nazl Tumori IRCCS Fdn G Pascale, Lab Med Unit, Naples, Italy
关键词
Prostate cancer; Randomized controlled trial; Diet; Physical activity; Counseling; Quality of life; Body composition; Microbiome; Serum biomarkers; Radiotherapy; QUALITY-OF-LIFE; RESEARCH FUND/AMERICAN INSTITUTE; PREVENTION RECOMMENDATIONS; RADIATION-THERAPY; BODY-COMPOSITION; EXERCISE; NUTRITION; FATIGUE; INTERVENTIONS; MEN;
D O I
10.1186/s12885-022-09521-4
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background: Prostate cancer (PCa) is the second most common cancer in men worldwide. The standard non-surgical approach for localized PCa is radiotherapy (RT), but one of the limitations of high-dose RT is the potential increase in gastrointestinal and genitourinary toxicities. We present the protocol of the Microstyle study, a multicentre randomized two-arm crossover clinical trial. The primary outcome will be assessed at the end of 6-month intervention, by measuring the change in adherence to a healthy lifestyle score. The hypothesis is that modifying lifestyle we change microbiome and improve quality of life and decrease side effects of RT. Methods: Study participants will be recruited among men undergoing RT in two Italian centers (Milan and Naples). We foresee to randomize 300 patients in two intervention 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). Dietitian and physiotherapist will work together to set individualized goals to reduce or eliminate side effects and pain according to their health status. All participants (IG) will be given a pedometer device (steps counter) in order to monitor and to spur participants to increase physical activity and reduce sedentary behavior. Participants included in the CG will receive baseline general advice and materials available for patients undergoing RT. According to the cross-over design, the CG will cross to the intervention approach after 6-month, to actively enhance compliance towards suggested lifestyle recommendations for all patients. Discussion: This trial is innovative in its design because we propose a lifestyle intervention during RT, that includes both dietary and physical activity counselling, as well as monitoring changes in microbiome and serum biomarkers. The promotion of healthy behaviour will be initiated before initiation of standard care, to achieve long lasting effects, controlling side effects, coping with feelings of anxiety and depression and improve efficacy of RT.
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页数:10
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