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Trial Outcomes & Findings for Behavioral Dietary Intervention for the Improvement of Bladder Cancer Survivorship (NCT NCT04548193)

NCT ID: NCT04548193

Last Updated: 2024-08-28

Results Overview

Will be measured using high performance liquid chromatography (HPLC)-based cyclocondensation assay. The outcome is defined as change from baseline in measured levels. Between-group difference of change from baseline was analyzed using Wilcoxon rank-sum tests.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

49 participants

Primary outcome timeframe

6 months

Results posted on

2024-08-28

Participant Flow

Forty nine patients were randomized; 7 participants were subsequently excluded due to death, loss of interest, other medical problems, they underwent a cystectomy, or loss to follow-up. Thus, a total of 42 participants completed both baseline and 6-month follow-up assessments, yielding a retention rate of 86%.

Participant milestones

Participant milestones
Measure
Arm A ( Experimental Arm)
6-month Cruciferae intervention
Arm B (Control Arm)
6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors
Overall Study
STARTED
25
24
Overall Study
COMPLETED
22
20
Overall Study
NOT COMPLETED
3
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Arm A ( Experimental Arm)
6-month Cruciferae intervention
Arm B (Control Arm)
6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors
Overall Study
Lost to Follow-up
0
1
Overall Study
Death
0
1
Overall Study
Not eligible. Participant underwent cystectomy in August
1
0
Overall Study
Withdrawal by Subject
2
2

Baseline Characteristics

Behavioral Dietary Intervention for the Improvement of Bladder Cancer Survivorship

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm A (Experimental Arm)
n=22 Participants
6-month Cruciferae intervention
Arm B (Control Arm)
n=20 Participants
6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors
Total
n=42 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
8 Participants
n=5 Participants
6 Participants
n=7 Participants
14 Participants
n=5 Participants
Age, Categorical
>=65 years
14 Participants
n=5 Participants
14 Participants
n=7 Participants
28 Participants
n=5 Participants
Age, Continuous
66.8 years
STANDARD_DEVIATION 9.6 • n=5 Participants
68.1 years
STANDARD_DEVIATION 9.1 • n=7 Participants
67.4 years
STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
6 Participants
n=7 Participants
12 Participants
n=5 Participants
Sex: Female, Male
Male
16 Participants
n=5 Participants
14 Participants
n=7 Participants
30 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
22 Participants
n=5 Participants
20 Participants
n=7 Participants
42 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
22 participants
n=5 Participants
20 participants
n=7 Participants
42 participants
n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: One patient from Arm B (Control arm) missed baseline and another patient from Arm B (Control arm) missed follow up data. Hence, only 18 patients are included in the final analysis

Will be measured using high performance liquid chromatography (HPLC)-based cyclocondensation assay. The outcome is defined as change from baseline in measured levels. Between-group difference of change from baseline was analyzed using Wilcoxon rank-sum tests.

Outcome measures

Outcome measures
Measure
Arm A (Experimental Arm)
n=22 Participants
6-month Cruciferae intervention
Arm B (Control Arm)
n=18 Participants
a 6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors
Urinary Isothiocyanates Levels
10.4 mM
Standard Deviation 22.5
4.3 mM
Standard Deviation 14.1

PRIMARY outcome

Timeframe: 6 months

Population: One patient missed follow up date and was not included in the final analysis. Hence only 19 patients are included in the arm B(Control arm) for this analysis.

Will be assessed using a questionnaire adapted from Thomson et al. to capture both intake and cooking styles. The outcome is defined as change from baseline in measured levels. Between-group difference of change from baseline was analyzed using Wilcoxon rank-sum tests.

Outcome measures

Outcome measures
Measure
Arm A (Experimental Arm)
n=22 Participants
6-month Cruciferae intervention
Arm B (Control Arm)
n=19 Participants
a 6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors
Cruciferae Intake Change
0.78 cups/day
Standard Deviation 0.87
0.058 cups/day
Standard Deviation 1.17

SECONDARY outcome

Timeframe: 6 months

Population: No data was collected for this outcome.

Will be evaluated via ribonucleic acid-sequencing (RNA-seq) as a surrogate for intermediate efficacy, conducted at Roswell Park's Genomics Shared Resource using NextSeq500 platform (Illumina Inc.). Will summarize changes between pre- and post-intervention for both arms and calculate point estimates and their corresponding 95% confidence intervals. Will analyze between-group differences in the change of outcome variables between baseline and post-intervention using ANCOVA.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Cruciferous vegetable intake, cups/day

Will be evaluated by three non-consecutive 24-hour dietary recalls (two weekdays, one weekday) conducted by trained staff using the interview-administered Nutrition Data System for Research (NDSR). The outcome is defined as change from baseline in measured levels. Between-group difference of change from baseline was analyzed using Wilcoxon rank-sum tests.

Outcome measures

Outcome measures
Measure
Arm A (Experimental Arm)
n=22 Participants
6-month Cruciferae intervention
Arm B (Control Arm)
n=20 Participants
a 6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors
Change in Cruciferous Vegetable Intake, Cups/Day
1.01 cups/day
Standard Deviation 1.31
0.07 cups/day
Standard Deviation 0.92

Adverse Events

Arm A ( Experimental Arm)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm B (Control Arm)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katy Wang

Roswell Park Comprehensive Cancer Center

Phone: 716-845-2300

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place