Trial Outcomes & Findings for Dietary Soy Isoflavones In Chronic Pancreatitis (NCT NCT02577640)
NCT ID: NCT02577640
Last Updated: 2021-11-12
Results Overview
Participants were evaluated for the development of bothersome symptoms that prevented them from being able to complete the recommended intervention course. Counts represent number of subjects who developed a symptom that prevented the ability to complete the dose/study period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
1 (dose escalation groups) or 4 (maximally tolerated dose) weeks
Results posted on
2021-11-12
Participant Flow
Participant milestones
| Measure |
Dose Escalation Group 1
DE group at 1 slice of bread per day.
|
Dose Escalation Group 2
DE group at 2 slices of bread per day
|
Dose Escalation Group 3
DE group at 3 slices of bread per day
|
Maximally Tolerated Dose
maximally tolerated dose of bread for 4 week period
|
|---|---|---|---|---|
|
Dose Escalation Group 1
STARTED
|
4
|
0
|
0
|
0
|
|
Dose Escalation Group 1
COMPLETED
|
3
|
0
|
0
|
0
|
|
Dose Escalation Group 1
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Dose Escalation Group 2
STARTED
|
0
|
3
|
0
|
0
|
|
Dose Escalation Group 2
COMPLETED
|
0
|
3
|
0
|
0
|
|
Dose Escalation Group 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Dose Escalation Group 3
STARTED
|
0
|
0
|
3
|
0
|
|
Dose Escalation Group 3
COMPLETED
|
0
|
0
|
3
|
0
|
|
Dose Escalation Group 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Maximally Tolerated Dose
STARTED
|
0
|
0
|
0
|
1
|
|
Maximally Tolerated Dose
COMPLETED
|
0
|
0
|
0
|
1
|
|
Maximally Tolerated Dose
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dietary Soy Isoflavones In Chronic Pancreatitis
Baseline characteristics by cohort
| Measure |
Dose Escalation Group 1
n=4 Participants
1 slice bread per day for 1 week
|
Dose Escalation Group 2
n=3 Participants
2 slices bread per day for 1 week
|
Dose Escalation Group 3
n=1 Participants
3 slices bread per day for 1 week
|
Maximally Tolerated Dose
n=1 Participants
maximally tolerated dose for 4 weeks
|
Total
n=9 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 (dose escalation groups) or 4 (maximally tolerated dose) weeksParticipants were evaluated for the development of bothersome symptoms that prevented them from being able to complete the recommended intervention course. Counts represent number of subjects who developed a symptom that prevented the ability to complete the dose/study period.
Outcome measures
| Measure |
Dose Escalation Group 1
n=3 Participants
1 slice bread per day
|
Dose Escalation Group 2
n=3 Participants
2 slices per day
|
Dose Escalation Group 3
n=3 Participants
3 slices per day
|
Maximally Tolerated Dose Group
n=1 Participants
maximally tolerated dose (3 slices/day)
|
|---|---|---|---|---|
|
Dose Limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 (dose escalation group) or 4 weeks (maximally tolerated subject)Population: For the purposes of analyzing the secondary outcomes all subjects completing any of the dose escalation groups were combined.
Changes in the serum were assessed for TNF-alpha prior to and following introduction of soy bread
Outcome measures
| Measure |
Dose Escalation Group 1
n=9 Participants
1 slice bread per day
|
Dose Escalation Group 2
n=1 Participants
2 slices per day
|
Dose Escalation Group 3
3 slices per day
|
Maximally Tolerated Dose Group
maximally tolerated dose (3 slices/day)
|
|---|---|---|---|---|
|
Pro-inflammatory Cytokines
Day 0 value of TNF-alpha
|
2.67 pg/mL
Standard Deviation 0.72
|
7.0 pg/mL
Standard Deviation 0
|
—
|
—
|
|
Pro-inflammatory Cytokines
Day 7 value of TNF-alpha
|
2.38 pg/mL
Standard Deviation 0.56
|
7.2 pg/mL
Standard Deviation 0
|
—
|
—
|
Adverse Events
Dose Escalation Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Escalation Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Escalation Group 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Maximally Tolerated Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place