Intervention Study in Prostate Cancer Patients Undergoing Radiotherapy

NCT05155618 | Unknown

• 1 other identifier: IEO 1442
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 2

Brief 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

Prostate Cancer

Keywords

Lifestyle; microbiota; diet; radiotherapy; physical activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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 Dietary intake

  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)

Study Arms (2)

Intervention group (IG)

EXPERIMENTAL

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.

Procedure: INTERVENTION GROUP

Control group (CG)

NO INTERVENTION

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.

Interventions

INTERVENTION GROUP PROCEDURE

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

Also known as: IG

Intervention group (IG)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Institute of Oncology: lead
• Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale: collaborator

Study Sites (2)

European Institute of Oncology

Milan, 20141, Italy

Location

Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale

Naples, 80131, Italy

Location

Related Publications (1)

• Gnagnarella 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 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Sara Gandini, MSc

  Department of Experimental Oncology, IEO, Milan

  PRINCIPAL INVESTIGATOR

• Valentina Borzillo, MD

  Department of Radiation Oncology, Istituto Nazionale Tumori IRCCS Fondazione G Pascale, Napoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Supportive Care: protocol designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In general, supportive care interventions are not intended to cure a disease.

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: December 13, 2021
• Study Start: November 8, 2021
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2025
• Last Updated: June 18, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)