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Prostate CancerMicroStyleNCT05155618

Intervention Study in Prostate Cancer Patients Undergoing Radiotherapy

A study testing INTERVENTION GROUP in people with Prostate Cancer, run by European Institute of Oncology at 2 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
INTERVENTION GROUP
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
311 participants
Where
2 sitesItaly
Study dates
8 Nov 2021to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • European Institute of Oncology

    Milan, 20141

  • Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale

    Naples, 80131

Other trials in Italy

About this study

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

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.

Read the detailed 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.

Conditions
Prostate Cancer
Being tested
INTERVENTION GROUP
Keywords
Lifestyle, microbiota, diet, radiotherapy, physical activity
Medical subject headings
Prostatic Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INTERVENTION GROUPProcedure or surgery

    Also called IG

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

Study groups in NCT05155618
Study groupRoleWhat they receive
Intervention group (IG)ExperimentalParticipants 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.
Receives: Procedure: INTERVENTION GROUP
Control group (CG)No interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: It will be assessed at the end of the 6-month intervention

Secondary outcomes (6)

  1. 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.

    Measured: 6-month - 12-month and 18-month (only for the CG)

  2. Change in body composition

    change in body composition assessed at all visits using bioelectrical impedance vector analysis (BIVA) compared to the baseline

    Measured: 6-month - up to 30 days - 12-month and 18-month (only for the CG)

  3. 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.

    Measured: 6-month - 12-month and 18-month (only for the CG)

  4. 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

    Measured: 6-month - up to 30 days - 12-month and 18-month (only for the CG)

  5. 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.

    Measured: 6-month and 12-month (only for the CG)

  6. 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.

    Measured: 6-month - up to 30 days - 12-month and 18-month (only for the CG)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2021
  2. Study start8 Nov 2021
  3. Primary completionJul 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
None (open label)
Enrolment
311 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05155618
Sponsor's protocol ID
IEO 1442
Acronym
MicroStyle
Status last verified
Jun 2023
First submitted
14 Sep 2021
Last updated
18 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35854230

Questions about this trial

What is this clinical trial studying?

A study testing INTERVENTION GROUP in people with Prostate Cancer, run by European Institute of Oncology at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in adherence to a healthy lifestyle score (time frame: It will be assessed at the end of the 6-month intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05155618, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.

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