Trial Outcomes & Findings for Trial of Aspirin and Arginine Restriction in Colorectal Cancer (NCT NCT00578721)

NCT ID: NCT00578721

Last Updated: 2023-07-07

Results Overview

To demonstrate a \> 50% decrease in rectal tissue putrescine levels from baseline in study subjects, as a measure of polyamine reduction in the target tissue of colorectal cancer patients.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2023-07-07

Participant Flow

Participant milestones

Measure	325 mg Aspirin 325 mg aspirin po qd with arginine-restricted diet Aspirin: 325 mg taken daily with an arginine-restricted diet
Overall Study STARTED	24
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Aspirin and Arginine Restriction in Colorectal Cancer

Baseline characteristics by cohort

Measure	325 mg Aspirin n=20 Participants 325 mg aspirin po qd with arginine-restricted diet Aspirin: 325 mg taken daily with an arginine-restricted diet
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 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	12 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	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

To demonstrate a > 50% decrease in rectal tissue putrescine levels from baseline in study subjects, as a measure of polyamine reduction in the target tissue of colorectal cancer patients.

Outcome measures

Measure	325 mg Aspirin n=20 Participants 325 mg aspirin po qd with arginine-restricted diet Aspirin: 325 mg taken daily with an arginine-restricted diet
Rectal Tissue Putrescine Reduction	17 Participants

SECONDARY outcome

Timeframe: 12 weeks

To determine the number and proportion of patients with any grade 1 or greater side effect, using Common Terminology for Adverse Events v4.0 (CTCAE)

Outcome measures

Measure	325 mg Aspirin n=20 Participants 325 mg aspirin po qd with arginine-restricted diet Aspirin: 325 mg taken daily with an arginine-restricted diet
Safety/Toxicity	6 Participants

Adverse Events

325 mg Aspirin

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	325 mg Aspirin n=20 participants at risk 325 mg aspirin po qd with arginine-restricted diet Aspirin: 325 mg taken daily with an arginine-restricted diet
General disorders Diarrhea	10.0% 2/20 • Number of events 2
General disorders Fatigue	15.0% 3/20 • Number of events 3
General disorders Neuropathy	5.0% 1/20 • Number of events 1
General disorders Myalgia	5.0% 1/20 • Number of events 1

Additional Information

Jason Zell, DO, MPH, MS

UC Irvine Health - Chao Family Comprehensive Cancer Center

Phone: 714-456-5153

Email: jzell@hs.uci.edu

Results disclosure agreements

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