Trial Outcomes & Findings for Fermented Wheat Germ Extract in Women With Ovarian Cancer (NCT NCT02411565)
NCT ID: NCT02411565
Last Updated: 2019-01-23
Results Overview
Adverse events reported per treatment arm. An adverse event is the development of an untoward medical occurrence, undesirable medical condition, or recurrence or deterioration of a pre-existing medical condition subsequent to exposure to FWGE. This study will utilize the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) for toxicity and adverse event reporting. Number of Adverse Events Probably Related to Study Treatment. All Adverse Events are listed, with causality noted in the Adverse Event section.
TERMINATED
EARLY_PHASE1
3 participants
Up to 2 months
2019-01-23
Participant Flow
Participants were enrolled at Moffitt Cancer Center March 2016 through February 2017.
Participant milestones
| Measure |
Fermented Wheat Germ Extract (FWGE)
FWGE administration 2 - 4 weeks prior to planned surgery.
|
Placebo Administration
Placebo administration 2 - 4 weeks prior to planned surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fermented Wheat Germ Extract in Women With Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Fermented Wheat Germ Extract (FWGE)
n=1 Participants
FWGE administration 2-4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O
|
Placebo Administration
n=2 Participants
Placebo administration 2-4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O
|
Total
n=3 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
n=5 Participants
|
74.5 years
n=7 Participants
|
70.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 monthsPopulation: All participants.
Adverse events reported per treatment arm. An adverse event is the development of an untoward medical occurrence, undesirable medical condition, or recurrence or deterioration of a pre-existing medical condition subsequent to exposure to FWGE. This study will utilize the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) for toxicity and adverse event reporting. Number of Adverse Events Probably Related to Study Treatment. All Adverse Events are listed, with causality noted in the Adverse Event section.
Outcome measures
| Measure |
Fermented Wheat Germ Extract (FWGE)
n=1 Participants
FWGE administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O.
|
Placebo Administration
n=2 Participants
Placebo administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O.
|
|---|---|---|
|
Occurrence of Adverse Events Probably Related to Study Treatment
|
1 Adverse Events
|
0 Adverse Events
|
SECONDARY outcome
Timeframe: Up to 2 monthsPopulation: Drug manufacturing issues prevented investigators from completing the planned analysis.
FACT-O Quality of Life Score comparison per category and arm: Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Additional Concerns. Score range for each question: 0 (Not at all) through 4 (Very much). High or Low Score could mean better or worse, depending on the wording of each group of questions. Investigators planned to analyze scores per treatment arm, in women who received Fermented Wheat Germ Extract (FWGE) (n=10) and those who received placebo (n=10). Drug manufacturing issues prevented investigators from completing the planned analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 monthsPopulation: Drug manufacturing issues prevented investigators from completing the planned analysis.
Investigators planned to perform Level comparison of 2,6-dimethoxy-p-benzoquinone (2,6-DMBQ) in the serum of women receiving FWGE versus placebo for 20 participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 monthsPopulation: Drug manufacturing issues prevented investigators from completing the planned analysis.
Biomarker-based response involves assessing the participant's longitudinal CA-125 values. The definition of CA-125 response is based on the Gynecologic Cancer Intergroup (GCIG 2005) criteria. CA-125 response was to be determined and compared between FWGE and placebo treated groups of 10 participants each.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 monthsChanges in tissue proliferative assays and gene expression per treatment arm.
Outcome measures
Outcome data not reported
Adverse Events
Fermented Wheat Germ Extract (FWGE)
Placebo Administration
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fermented Wheat Germ Extract (FWGE)
n=1 participants at risk
FWGE administration 2 - 4 weeks prior to planned surgery.
|
Placebo Administration
n=2 participants at risk
Placebo administration 2 - 4 weeks prior to planned surgery.
|
|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • 1 year, 1 month
|
50.0%
1/2 • Number of events 1 • 1 year, 1 month
|
|
Investigations
Investigations - Other, Total protein decreased
|
100.0%
1/1 • Number of events 1 • 1 year, 1 month
|
50.0%
1/2 • Number of events 1 • 1 year, 1 month
|
|
Investigations
Investigations - Other, Elevated phosphorous
|
100.0%
1/1 • Number of events 1 • 1 year, 1 month
|
0.00%
0/2 • 1 year, 1 month
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/1 • 1 year, 1 month
|
50.0%
1/2 • Number of events 1 • 1 year, 1 month
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/1 • 1 year, 1 month
|
50.0%
1/2 • Number of events 1 • 1 year, 1 month
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
1/1 • Number of events 1 • 1 year, 1 month
|
50.0%
1/2 • Number of events 1 • 1 year, 1 month
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
1/1 • Number of events 1 • 1 year, 1 month
|
50.0%
1/2 • Number of events 1 • 1 year, 1 month
|
|
Nervous system disorders
Dysgeusia
|
100.0%
1/1 • Number of events 1 • 1 year, 1 month
|
0.00%
0/2 • 1 year, 1 month
|
Additional Information
Dr. Hye Sook Chon
H. Lee Moffitt Cancer Center and Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place