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Trial Outcomes & Findings for Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients (NCT NCT04046094)

NCT ID: NCT04046094

Last Updated: 2025-03-25

Results Overview

Post treatment specimen pathology results evaluated per the WHO TNM staging system. The staging system is a qualitative assessment based on the results of the physical exam, biopsy, imaging tests, and the results of surgery. The earliest stage cancers are called stage 0 (or carcinoma in situ), and then range from stages I (1) through IV (4). As a rule, the lower the number, the less the cancer has spread. A higher number, such as stage IV, means a more advanced cancer.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

6 weeks after first IVC infusion at radical cystectomy

Results posted on

2025-03-25

Participant Flow

Participant milestones

Participant milestones
Measure
IV Ascorbic Acid
IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks Ascorbic Acid: Ascorbic Acid Intravenous
Overall Study
STARTED
12
Overall Study
COMPLETED
12
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
IV Ascorbic Acid
n=12 Participants
IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks Ascorbic Acid: Ascorbic Acid Intravenous
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=5 Participants
Age, Categorical
>=65 years
11 Participants
n=5 Participants
Age, Continuous
76.3 years
STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
11 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
12 participants
n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks after first IVC infusion at radical cystectomy

Post treatment specimen pathology results evaluated per the WHO TNM staging system. The staging system is a qualitative assessment based on the results of the physical exam, biopsy, imaging tests, and the results of surgery. The earliest stage cancers are called stage 0 (or carcinoma in situ), and then range from stages I (1) through IV (4). As a rule, the lower the number, the less the cancer has spread. A higher number, such as stage IV, means a more advanced cancer.

Outcome measures

Outcome measures
Measure
IV Ascorbic Acid
n=12 Participants
IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks Ascorbic Acid: Ascorbic Acid Intravenous
Post Treatment Pathological Staging
Stage 0
3 Participants
Post Treatment Pathological Staging
Stage I
2 Participants
Post Treatment Pathological Staging
Stage II
1 Participants
Post Treatment Pathological Staging
Stage III
4 Participants
Post Treatment Pathological Staging
Stage IV
2 Participants

SECONDARY outcome

Timeframe: Baseline, End of Treatment (completion of neoadjuvant therapy, Day 28), Post-surgery (6 weeks post-operative)

Scores evaluated per Functional Assessment of Cancer Therapy - Bladder (FACT-Bl) version 4 - quality of life (QOL) questionnaire scores: * FACT-Bl total score range is 0-156, derived by the sum of the sub-scales. Higher scores indicate better QOL. * FACT-Bl includes five sub-scales: * Physical Well-being (PWB), score range of 0-28 * Social/Family Well-being (SWB), score range of 0-28 * Emotional Well-being (EWB), score range of 0-24 * Functional Well-being (FWB), score range of 0-28 * Bladder Cancer Subscale (BlCS), score range of 0-48 * Note: Negatively stated items are reversed by subtracting the response from "4".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

DFS will be defined as time from cystectomy to disease recurrence or death resulting from disease. DFS represents time from random assignment to cancer recurrence or death from any cause. Patients alive without disease progression at the time of analysis were censored at the date of last disease assessment.

Outcome measures

Outcome data not reported

Adverse Events

IV Ascorbic Acid

Serious events: 2 serious events
Other events: 0 other events
Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure
IV Ascorbic Acid
n=12 participants at risk
IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks Ascorbic Acid: Ascorbic Acid Intravenous
Gastrointestinal disorders
Ileus
16.7%
2/12 • Number of events 2 • 4 years

Other adverse events

Adverse event data not reported

Additional Information

Faith Rahman

University of Kansas Medical Center

Phone: 913-588-2502

Results disclosure agreements

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