Clinical trial · Interventional
Intervention Study in Prostate Cancer Patients Undergoing Radiotherapy
Intervention Study on Life Style and Microbiota in Prostate Cancer Patients Undergoing Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INTERVENTION GROUP | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group (IG)
- description
- 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.
- interventionNames
- Procedure: INTERVENTION GROUP
- type
- NO_INTERVENTION
- label
- Control group (CG)
- description
- 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.
Primary outcomes (1)
- measure
- Change in adherence to a healthy lifestyle score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGnagnarella P, Marvaso G, Jereczek-Fossa BA, de Cobelli O, Simoncini MC, Nevola Teixeira LF, Sabbatini A, Pravettoni G, Johansson H, Nezi L, Muto P, Borzillo V, Celentano E, Crispo A, Pinto M, Cavalcanti E, Gandini S; MicroStyle Collaborative Group. Life style and interaction with microbiota in prostate cancer patients undergoing radiotherapy: study protocol for a randomized controlled trial. BMC Cancer. 2022 Jul 19;22(1):794. doi: 10.1186/s12885-022-09521-4. PMID 35854230