NCT07391137: CRUCIAL-R

CRUCIAL-R Study : Cruciferous Vegetables Dietary Regimen in NMIBC

Active, enrolled NA Last updated 9 February 2026

What this trial tests

NA trial testing Cruciferae intake diet in Recurrence Free Survival in 250 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 October 2025

Primary endpoint
1 November 2026

1 May 2027

Quick facts

Lead sponsor	S. Andrea Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	250
Start date	17 October 2025
Primary completion	1 November 2026
Estimated completion	1 May 2027
Sites	1 location across Italy

Drugs / interventions tested

• Cruciferae intake diet
• Habituary dietary regimen

Conditions studied

• Recurrence Free Survival — all drugs for Recurrence Free Survival →
• Bladder Cancer Recurrence — all drugs for Bladder Cancer Recurrence →

Sponsor

S. Andrea Hospital

Who can join

Adults 18 to 75, any sex, with Recurrence Free Survival or Bladder Cancer Recurrence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.