Intervention Study in Prostate Cancer Patients Undergoing Radiotherapy

Prostate Cancer Clinical Trial

— MicroStyle  

Official title:

Intervention Study on Life Style and Microbiota in Prostate Cancer Patients Undergoing Radiotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05155618
• Other study ID #: IEO 1442
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 8, 2021
• Est. completion date: December 2025

Study information

• Verified date: June 2023
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 311
• Est. completion date: December 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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) = 2. 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• INTERVENTION GROUP
Personalized advice to prevent side effect according to their health status will be provided by a dietitian and a physiotherapist.

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan
Italy	Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale	Naples

Sponsors (2)

Lead Sponsor	Collaborator
European Institute of Oncology	Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in adherence to a healthy lifestyle score	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).	It will be assessed at the end of the 6-month intervention
Secondary	The effects of the interventions on serum biomarkers	differences by arms in changes of Prostate-specific antigen (PSA) (mcg/L) and 25-hydroxyvitamin D (ng/mL) compared to the baseline.	6-month - 12-month and 18-month (only for the CG)
Secondary	Change in body composition	change in body composition assessed at all visits using bioelectrical impedance vector analysis (BIVA) compared to the baseline	6-month - up to 30 days - 12-month and 18-month (only for the CG)
Secondary	Change in quality of Life	change in quality of life, measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire which consists of 39 items. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores. Higher scores represent better QoL.	6-month - 12-month and 18-month (only for the CG)
Secondary	Change in Dietary intake	change in daily or weekly intake of the main food groups included in a validated short self-administered questionnaire over the previous months and the change over the study	6-month - up to 30 days - 12-month and 18-month (only for the CG)
Secondary	change in the level of physical activity	The International Physical Activity Questionnaire (IPAQ)- Short Form will be used. It obtains information about how much time is spent while walking and in moderate and vigorous activities and sitting duration in the last 7 days. The questionnaire records the activity of four intensity levels: 1) vigorous-intensity activity, 2) moderate-intensity activity, 3) walking, and 4) sitting. Durations are multiplied by known metabolic equivalent of tasks (METs) per activity and the results for all items are summed for the overall physical activity score. Scores for walking and for moderate and vigorous activities are sums of corresponding item scores. The change in the level of physical activity will be estimated and compared to the baseline.	6-month and 12-month (only for the CG)
Secondary	Change in acute and late toxicity	change in toxicity according to Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC) scoring criteria. It consists of a scoring range from 0 to 5 where 0 means an absence of radiation effects and 5 means the effects led to death, compared to the baseline.	6-month - up to 30 days - 12-month and 18-month (only for the CG)