CRUCIAL-R Study : Cruciferous Vegetables Dietary Regimen in NMIBC

NCT07391137 | Active Not Recruiting

• 1 other identifier: CRUCIAL-R
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Emerging evidence highlights the importance of nutrition in modulating cancer-related pathways, suggesting that specific dietary patterns and food choices may influence cancer risk. A protective role has been suggested for high consumption of vegetables, non-saturated fat oil (Mediterranean diet), fruits, and flavonoids \[10-13\]. In contrast, a diet rich in saturated fats and meat has been linked to an increased risk of BC \[14,15\]. Particularly, the consumption of vegetables of the Cruciferae family, such as broccoli, cauliflower, brussels sprouts, cabbage, kale, turnips, and others, has gathered attention for their potential protective effects due to their bioactive compounds: Isothiocyanates (ITCs). Dietary ITCs are a group of phytochemicals with multifaceted anticancer mechanisms primarily derived from cruciferous vegetables (CV) as glucosinolates and converted to ITCs by the action of the enzyme myrosinase \[16\]. Organic ITCs, particularly allyl isothiocyanate (AITC), benzyl isothiocyanate (BITC), phenethyl isothiocyanate (PEITC), and sulforaphane (SF), are among the most extensively studied cancer chemopreventive agents. Several mechanisms for ITCs in protection against carcinogenesis have been proposed, which include inhibition of carcinogen activation and promotion of detoxification, induction of cell cycle arrest and activation of apoptosis, inhibition of cancer cell invasion, modulation of the tumor microenvironment, inhibition of self-renewal of stem cells, rearrangement of energy metabolism and regulation of microbial homeostasis \[17-22\]. Aims Primary Objective

• To evaluate the effect, in terms of recurrence-free survival (RFS) at 1 year, of a dietary regimen characterized by high consumption of the Cruciferae family vegetables versus no dietary regimen in patients with Intermediate, High, or Very High-grade Non-Muscle Invasive Bladder Cancer treated with BCG (defined as the standard of care - SOC). Secondary Objectives
• To evaluate the effect, in terms of time to recurrence, of a dietary regimen characterized by high consumption of the Cruciferae family vegetables versus no dietary regimen in patients with Intermediate, High, and Very High-grade Non-Muscle Invasive Bladder Cancer.
• To evaluate the effect, in terms of recurrence-free survival (RFS), of a dietary regimen characterized by high consumption of the Cruciferae family vegetables versus no dietary regimen in patients with Intermediate, High, and Very High-grade Non-Muscle Invasive Bladder Cancer with prior recurrence ≤1/yr and \<4 tumors (according to 2016 EORTC risk stratification for patients treated with maintenance BCG).
• To evaluate the impact of high Cruciferous vegetable consumption on urinary ITC levels.
• To evaluate the impact of high Cruciferous vegetable consumption on quality of life (QoL).

Conditions

Recurrence Free Survival; Bladder Cancer Recurrence

Keywords

Bladder Cancer; NMIBC; Cruciferae; recurrence

Outcome Measures

Primary Outcomes (1)

• Recurrence Free Survival

  of recurrence-free survival (RFS) at 1 year, of a dietary regimen characterized by high consumption of the Cruciferae family vegetables versus no dietary regimen in patients with Intermediate, High, or Very High-grade Non-Muscle Invasive Bladder Cancer treated with BCG (defined as the standard of care - SOC).

  24 months

Secondary Outcomes (2)

• Recurrence in BCa

  24 months

• ITC levels

  24 months

Study Arms (2)

1 - Patients with Cruciferae intake diet

EXPERIMENTAL

Patients with Cruciferae intake diet

Dietary Supplement: Cruciferae intake diet

2

PLACEBO COMPARATOR

Patients with normal diet

Dietary Supplement: Habituary dietary regimen

Interventions

Cruciferae intake diet DIETARY_SUPPLEMENT

Patients in the intervention group will receive a dietary regimen characterized by high consumption of Cruciferae vegetables \[≥1 cup /day\] for 6 months. Patients in this group will receive educative booklets on the Cruciferae family of vegetables and visual charts on serving sizing to meet the recommended daily CV intake. Patients will be asked to record daily Cruciferae intake. They will receive a live phone call every week to verify their understanding of the educational information and the consistency of the dietary regimen.

1 - Patients with Cruciferae intake diet

Habituary dietary regimen DIETARY_SUPPLEMENT

Patients randomized in the control group will receive standard of care (SOC) without any modification of the habitual dietary regimen.

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed Non-Muscle Invasive Bladder Cancer of Intermediate, High, or Very High risk according to the 2021 EAU NMIBC scoring model.
• Age ≥ 18

You may not qualify if:

• Low-Risk Non-Muscle Invasive Bladder Cancer
• Muscle Invasive Bladder Cancer
• Life expectancy \< 5 years
• WHO performance status 3 or 4
• Variant histology
• Concomitant Urothelial Bladder Cancer in the Upper-Urinary Tract
• Prostate or bladder radiotherapy
• Urinary tract infection
• Chronic urinary retention or indwelling catheters
• Other ongoing oncological diseases
• Active oncological treatments in the past 12 months
• Persistent disease (defined as residual disease detected within three months after TURB or at first cystoscopy)
• Specific dietary restrictions such as a vegetarian diet, celiac disease, or lactose intolerance
• Chronic Kidney Disease
• Chronic inflammatory diseases such as Crohn's disease or ulcerative colitis

Sponsors & Collaborators

• S. Andrea Hospital: lead

Study Sites (1)

S.Andrea Hospital of Rome

Rome, Lazio, 00135, Italy

Location

Related Links

• Burger M, Catto JWF, Dalbagni G, Grossman HB, Herr H, Karakiewicz P, Kassouf W, Kiemeney LA, La Vecchia C, Shariat S, Lotan Y. Epidemiology and risk factors of urothelial bladder cancer. Eur Urol \[Internet\]. 2013 \[cited 2025 Jan 26\];63(2):234-41.
• Egbers L, Grotenhuis AJ, Aben KK, Witjes JA, Kiemeney LA, Vermeulen SH. The prognostic value of family history among patients with urinary bladder cancer. Int J Cancer \[Internet\]. 2015 Mar 1 \[cited 2025 Jan 26\];136(5):1117-24
• Jubber I, Ong S, Bukavina L, Black PC, Compérat E, Kamat AM, Kiemeney L, Lawrentschuk N, Lerner SP, Meeks JJ, Moch H, Necchi A, Panebianco V, Sridhar SS, Znaor A, Catto JWF, Cumberbatch MG. Epidemiology of Bladder Cancer in 2023: A Systematic Review of R

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cosimo De Nunzio, Professor

  Sant'Andrea Hospital of Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: P.I. Professor

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: February 5, 2026
• Study Start: October 17, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Two years

Locations

IT (1)