Trial Outcomes & Findings for Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed by Surgery (NCT NCT03757949)

Last Updated: 2025-05-15

Results Overview

A post-operative complication is defined as a binary indicator variable indicating whether the patient experienced any complication (any/none; Clavien-Dindo grades I-V). The primary analysis will be based on a multivariable logistic regression under intent-totreat among all randomized patients, irrespective of their eligibility status, adjusting for the specified stratification factors: a. Diversion type (neobladder versus \[vs.\] ileal conduit); b. Prior neoadjuvant chemotherapy (any vs. none); and c. Nutrition status (well nourished vs. moderate malnutrition). A Fisher's exact test will also be conducted to establish whether the results are sensitive to model assumptions. A single interim analysis for efficacy will be conducted when 50% of patients achieve their endpoint at the alpha=0.005 level. Accordingly, the final analysis will be conducted at the alpha=0.045 level. A separate analysis among all eligible randomized patients will also be conducted.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

203 participants

Primary outcome timeframe

Up to 30 days post surgery

Results posted on

2025-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (SIM) Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0. Laboratory Biomarker Analysis: Correlative studies Nutritional Intervention: Receive SIM PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Arm II (Placebo) ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0. Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Overall Study STARTED	99	104
Overall Study COMPLETED	90	88
Overall Study NOT COMPLETED	9	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (SIM) n=99 Participants Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0. Laboratory Biomarker Analysis: Correlative studies Nutritional Intervention: Receive SIM PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Arm II (Placebo) n=104 Participants ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0. Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Total n=203 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	33 Participants n=5 Participants	32 Participants n=7 Participants	65 Participants n=5 Participants
Age, Categorical >=65 years	66 Participants n=5 Participants	72 Participants n=7 Participants	138 Participants n=5 Participants
Age, Continuous	68 years n=5 Participants	69.45 years n=7 Participants	68.8 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	77 Participants n=5 Participants	85 Participants n=7 Participants	162 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	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants	79 Participants n=7 Participants	147 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	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United States	99 participants n=5 Participants	104 participants n=7 Participants	203 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 days post surgery

Population: Participants who are evaluable at day 30

Outcome measures

Outcome measures
Measure	Arm I (SIM) n=90 Participants Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0. Laboratory Biomarker Analysis: Correlative studies Nutritional Intervention: Receive SIM PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Arm II (Placebo) n=88 Participants ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0. Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Post-operative Complications	56 Participants	51 Participants

Serious events: 2 serious events

Other events: 68 other events

Deaths: 9 deaths

Arm II (Placebo)

Serious events: 2 serious events

Other events: 67 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (SIM) n=91 participants at risk Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.XXXLaboratory Biomarker Analysis: Correlative studiesXXXNutritional Intervention: Receive SIM POXXXQuality-of-Life Assessment: Ancillary studiesXXXQuestionnaire Administration: Ancillary studies	Arm II (Placebo) n=88 participants at risk ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.XXXLaboratory Biomarker Analysis: Correlative studiesXXXPlacebo Administration: Given POXXXQuality-of-Life Assessment: Ancillary studiesXXXQuestionnaire Administration: Ancillary studies
Cardiac disorders Cardiac arrest	0.00% 0/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.	2.3% 2/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.	1.1% 1/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
Infections and infestations Kidney infection	1.1% 1/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.	0.00% 0/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
Infections and infestations Sepsis	1.1% 1/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.	0.00% 0/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.00% 0/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.	1.1% 1/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.	1.1% 1/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.

Other adverse events

Additional Information

Danika Lew

SWOG

Phone: 206-667-2272

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place