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Drug manufacturing issues
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The main purpose of this Pilot Study is to test the safety, tolerability and quality of life in women who take Fermented Wheat Germ Extract (FWGE), to determine if an active form of FWGE can be detected in the blood, and determine whether short-term therapy with FWGE has any effect on the tumor marker, cancer antigen 125 (CA-125).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fermented Wheat Germ Extract (FWGE) | Active Comparator | FWGE administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O. |
|
| Placebo Administration | Placebo Comparator | Placebo administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermented Wheat Germ Extract (FWGE) | Drug | 5.53 grams of FWGE combined with natural orange flavor and stevia Reb-A sweetener to create an instant drink mix, dissolved in 150 mL of water, orally once-daily, for 2 to 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Events Probably Related to Study Treatment | 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. | Up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Scores Per Treatment Arm | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Changes in Tissue Proliferative Assays and Gene Expression | Changes in tissue proliferative assays and gene expression per treatment arm. | Up to 2 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hye Sook Chon, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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Participants were enrolled at Moffitt Cancer Center March 2016 through February 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fermented Wheat Germ Extract (FWGE) | FWGE administration 2 - 4 weeks prior to planned surgery. |
| FG001 | Placebo Administration | Placebo administration 2 - 4 weeks prior to planned surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fermented Wheat Germ Extract (FWGE) | FWGE administration 2-4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O |
| BG001 | Placebo Administration | Placebo administration 2-4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occurrence of Adverse Events Probably Related to Study Treatment | 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. | All participants. | Posted | Number | Adverse Events | Up to 2 months |
|
1 year, 1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fermented Wheat Germ Extract (FWGE) | FWGE administration 2 - 4 weeks prior to planned surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment | Unrelated to study treatment |
Accrual was closed prematurely due to drug manufacturing issues and slow enrollment. Outcome Measures were designed for 20 participants, to complete a comparison of 2 study arms with 10 participants each.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hye Sook Chon | H. Lee Moffitt Cancer Center and Research Institute | 813-745-7205 | hyesook.chon@moffitt.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2017 | Jun 12, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C113915 | Avemar |
| D011788 | Quality of Life |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
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|
| Placebo | Drug | Dried and pulverized, white and black rice, 5.53 grams, combined with natural orange flavor and stevia Reb-A sweetener, to create an instant drink mix, dissolved in 150 mL of water, orally once-daily, for 2 to 4 weeks. |
|
| Standard of Care: Planned Surgery | Other | Participants will undergo their planned surgery during the 2nd to 4th week after entry into the study. However, if there are delays, patients can continue to take drug/placebo for a time period no greater than 2 months. If surgery has not occurred after this 2-month period, the patient will be removed from the study. Participants will take the study drug up until the day prior to surgery. The minimum amount of time on study drug is 2 weeks. A separate consent form will be obtained for the surgical procedure. |
|
| Quality of Life (QoL) Surveys: FACT-O | Other | Quality of life questionnaire (FACT-O) at the time of enrollment, then weekly and the day of surgery. |
|
|
| Up to 2 months |
| Level of 2,6-dimethoxy-p-benzoquinone (2,6-DMBQ) | 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. | Up to 2 months |
| Occurence of CA-125 Response | 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. | Up to 2 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Placebo Administration |
Placebo administration 2 - 4 weeks prior to planned surgery, + Quality of Life (QoL) Surveys: FACT-O. |
|
|
| Secondary | Quality of Life Scores Per Treatment Arm | 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. | Drug manufacturing issues prevented investigators from completing the planned analysis. | Posted | Up to 2 months |
|
|
| Secondary | Level of 2,6-dimethoxy-p-benzoquinone (2,6-DMBQ) | 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. | Drug manufacturing issues prevented investigators from completing the planned analysis. | Posted | Up to 2 months |
|
|
| Secondary | Occurence of CA-125 Response | 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. | Drug manufacturing issues prevented investigators from completing the planned analysis. | Posted | Up to 2 months |
|
|
| Other Pre-specified | Incidence of Changes in Tissue Proliferative Assays and Gene Expression | Changes in tissue proliferative assays and gene expression per treatment arm. | Not Posted | Up to 2 months | Participants |
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Placebo Administration | Placebo administration 2 - 4 weeks prior to planned surgery. | 0 | 2 | 0 | 2 | 1 | 2 |
|
| Investigations - Other, Total protein decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment | Unrelated to study treatment |
|
| Investigations - Other, Elevated phosphorous | Investigations | CTCAE (4.0) | Non-systematic Assessment | Unrelated to study treatment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | Unrelated to study treatment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | Unrelated to study treatment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | Unrelated to study treatment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | Unrelated to study treatment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment | Probably related to study treatment |
|
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D004778 |
| Environment and Public Health |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |