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Intervention Study in Prostate Cancer Patients Undergoing Radiotherapy

NCT05155618 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2024-06-18

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

INTERVENTION GROUP

Personalized advice to prevent side effect according to their health status will be provided by a dietitian and a physiotherapist.

Sponsors & Collaborators

  • Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

    collaborator NETWORK

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Sara Gandini, MSc · Department of Experimental Oncology, IEO, Milan

  • Valentina Borzillo, MD · Department of Radiation Oncology, Istituto Nazionale Tumori IRCCS Fondazione G Pascale, Napoli

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2024-07-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05155618 on ClinicalTrials.gov