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| Name | Class |
|---|---|
| Oregon State University | OTHER |
| Pacific Northwest National Laboratory | FED |
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A pilot study to assess the safety and tolerability of oral xanthohumol in humans, to identify a biological signature of xanthohumol exposure, and to characterize the role of xanthohumol metabolism by intestinal microorganisms in that signature.
This is a double-masked, placebo controlled, randomized clinical trial of xanthohumol, which is a constituent of hops (Humulus lupulus). Hops and its constituents have a long history of use for a variety of conditions. However, knowledge is limited regarding the measurable biological markers of human exposure, and the role of xanthohumol metabolism by microorganisms present in the gut. This information is necessary for the development of xanthohumol as a potential therapeutic intervention in conditions such as inflammatory bowel disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xanthohumol | Experimental | Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal. |
|
| Placebo oral capsule | Placebo Comparator | Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xanthohumol | Drug | The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Plasma Inflammatory Markers | Circulating pro-inflammatory cytokine concentrations (tumor necrosis factor (TNF)-α, interleukin (IL)-1 beta, IL-6, IL-8, IL-10, and IL-12p70), will be measured simultaneously with a flow cytometry-based multiplex assay. The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; weeks 2, 4, 6, and 8 reported | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
| Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Self-reported adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events. Reported as: New onset "FDA serious" adverse events (Grade 1); New onset "moderate" adverse events (Grade 2). The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; weeks 2, 4, 6, and 8 reported. | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Xanthohumol and xanthohumol metabolites in blood, urine and stool, will be measured by ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry. Metabolites include 6-prenylnaringenin (6-PN), 8-prenylnaringenin (8-PN), dihydroxanthohumol (DXN), desmethyldihydroxanthohumol (DDXN), isoxanthohumol (IXN), and xanthohumol (XN). The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; baseline, weeks 2, 4, 6, and 8 reported for urine and plasma. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Bradley, ND, MPH | National University of Natural Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helfgott Research Institute National University of Natural Medicine | Portland | Oregon | 97201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38358253 | Derived | Jamieson PE, Smart EB, Bouranis JA, Choi J, Danczak RE, Wong CP, Paraiso IL, Maier CS, Ho E, Sharpton TJ, Metz TO, Bradley R, Stevens JF. Gut enterotype-dependent modulation of gut microbiota and their metabolism in response to xanthohumol supplementation in healthy adults. Gut Microbes. 2024 Jan-Dec;16(1):2315633. doi: 10.1080/19490976.2024.2315633. Epub 2024 Feb 15. | |
| 33028396 |
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We will use the University of California San Diego (UCSD) Metabolomics Workbench for sharing metabolomics datasets and results (including raw data matrices, platform information, and associated metadata).
For activity-based proteomics data, we will use PRIDE or the MassIVE data repository at UCSD.
Nucleic acid sequence data will be submitted to the National Center for Biotechnology Information (NCBI) Short Read Archive.
Gene expression data will be submitted to Gene expression Omnibus at NCBI. Microbiome metadata will be deposited into database of Genotypes and Phenotypes.
Metagenomic nucleic acid sequence data will additionally be deposited in Metagenomic Rapid Annotations using Subsystems Technology (MG-RAST) at Argonne National Laboratory, along with associated metadata.
Microbiome summary files (e.g., tables cataloging: sample metadata, taxon or protein family abundances across samples) publicly available through github.
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We will share our data no later than on acceptance of the first publication of the findings from the respective data set(s).
All indicated repositories are freely available to the research community.
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| ID | Title | Description |
|---|---|---|
| FG000 | Xanthohumol | Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal. Xanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks. |
| FG001 | Placebo Oral Capsule | Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal. Placebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xanthohumol | Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal. Xanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Plasma Inflammatory Markers | Circulating pro-inflammatory cytokine concentrations (tumor necrosis factor (TNF)-α, interleukin (IL)-1 beta, IL-6, IL-8, IL-10, and IL-12p70), will be measured simultaneously with a flow cytometry-based multiplex assay. The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; weeks 2, 4, 6, and 8 reported | Posted | Mean | Standard Deviation | picogram per milliliter (pg/mL) | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
|
8 weeks
Mild/Grade 1: No intervention; asymptomatic lab or radiographic findings; marginal clinical significance Moderate/Grade 2: OTC or single-physician visit; AE limited activities of daily living for <48hrs Severe/Grade 3: AE significantly limited basic self-care but did not require initial hospitalization or prolongation of hospitalization; Not immediately life-threatening but disabling Serious/Grade 4: Life threatening Serious/Grade 5: Death
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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 | Xanthohumol | Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal. Xanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | NCI CTCAEv4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Bradley, ND, MPH | National University of Natural Medicine | 5035521862 | rbradley@nunm.edu |
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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 | Oct 1, 2019 | Aug 16, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C104536 | xanthohumol |
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Participants will be randomized to receive either encapsulated xanthohumol in a rice protein vehicle, or an identical capsule containing vehicle alone.
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Randomization will occur in up to 8 blocks of 4 based on biological sex. Initial randomization series will be generated using readily available random sequence generators designed to do so. A series of sequential envelopes will be generated, each containing the allocation for one participant. Envelopes will be opaque and signed across the seal. The randomization "code" will be kept in a sealed envelope with a signature across the label and dated the day of creation. Study product and comparator (placebo) will be compounded and placed in identical opaque capsules outside the institution.
| Placebo oral capsule | Drug | The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal. |
|
|
| Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
| Change in Levels of Metabolic Byproducts of Xanthohumol: Stool | Xanthohumol and xanthohumol metabolites in blood, urine and stool, will be measured by ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry. Metabolites include 6-prenylnaringenin (6-PN), 8-prenylnaringenin (8-PN), dihydroxanthohumol (DXN), desmethyldihydroxanthohumol (DDXN), isoxanthohumol (IXN), and xanthohumol (XN). The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; baseline, weeks 2, 4, 6, and 8 reported for urine and plasma. As stool metabolites have not yet been analyzed, data will be released upon assessment. | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
| Bile Acids | Bile acid concentrations in blood and feces, will be measured by ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry, and expressed as mean change over time from baseline. | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
| Gut Inflammation | Fecal calprotectin, a protein associated with gut inflammation and irritable gut syndrome, will be measured by enzyme-linked immunosorbent assay, and expressed as mean change over time from baseline. | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
| Aspartate Aminotransferase (AST) | Aspartate aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline. | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
| Alanine Aminotransferase (ALT) | Alanine aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline. | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
| Gamma-Glutamyl Transferase (GGT) | Gamma-glutamyl transferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline. | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks |
| Estimated Glomerular Filtration Rate | Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice. Reported as mean change from baseline. | 2 weeks, 4 weeks, 6 weeks, and 8 weeks |
| Blood Urea Nitrogen to Creatinine Ratio | Blood urea nitrogen (BUN) : creatinine (Cr) is a ratio of serum concentrations of two compounds associated with renal function. Reported as mean change from baseline. | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
| Complete Blood Count Abnormals | Enumeration of the various subtypes of blood cells (i.e., red blood cells, white blood cells, and platelets), plus indices including mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), and hematocrit. Reported as: % abnormal (i.e., number of participants with an abnormal value compared to the number of participants in the group) and % new abnormals if abnormal counts were noted. Abnormality is assessed according to standards for age and sex measurements under Quest Diagnostics criteria. | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
| Total Red Blood Cell Count | Enumeration of total red blood cell count. Reported as mean change from baseline. | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
| Total White Blood Cell Count | Enumeration of total white blood cell count. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8. | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
| Platelet Count | Enumeration of platelet count. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8. | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
| Mean Corpuscular Volume | Enumeration of mean corpuscular volume (MCV). Results are reported as mean change from baseline at weeks 2, 4, 6, and 8. | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
| Mean Corpuscular Hemoglobin | Enumeration of mean corpuscular hemoglobin (MCH). Results are reported as mean change from baseline at weeks 2, 4, 6, and 8. | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
| Hematocrit | Enumeration of hematocrit. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8. | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
| Bradley R, Langley BO, Ryan JJ, Phipps J, Hanes DA, Stack E, Jansson JK, Metz TO, Stevens JF. Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial. Trials. 2020 Oct 7;21(1):835. doi: 10.1186/s13063-020-04769-2. |
| BG001 |
| Placebo Oral Capsule |
Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal. Placebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal. |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| Body mass index | Mean | Standard Deviation | kilogram per meters-squared (kg/m2) |
|
| Heart rate | Mean | Standard Deviation | beats per minute (bpm) |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Height | Mean | Standard Deviation | meters |
|
Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal. Xanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks. |
|
|
| Primary | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Self-reported adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events. Reported as: New onset "FDA serious" adverse events (Grade 1); New onset "moderate" adverse events (Grade 2). The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; weeks 2, 4, 6, and 8 reported. | Posted | Number | Adverse events | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
|
|
|
| Secondary | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Xanthohumol and xanthohumol metabolites in blood, urine and stool, will be measured by ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry. Metabolites include 6-prenylnaringenin (6-PN), 8-prenylnaringenin (8-PN), dihydroxanthohumol (DXN), desmethyldihydroxanthohumol (DDXN), isoxanthohumol (IXN), and xanthohumol (XN). The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; baseline, weeks 2, 4, 6, and 8 reported for urine and plasma. | Posted | Mean | Standard Deviation | nanograms per millileter (ng/mL) | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
|
|
|
| Secondary | Change in Levels of Metabolic Byproducts of Xanthohumol: Stool | Xanthohumol and xanthohumol metabolites in blood, urine and stool, will be measured by ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry. Metabolites include 6-prenylnaringenin (6-PN), 8-prenylnaringenin (8-PN), dihydroxanthohumol (DXN), desmethyldihydroxanthohumol (DDXN), isoxanthohumol (IXN), and xanthohumol (XN). The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; baseline, weeks 2, 4, 6, and 8 reported for urine and plasma. As stool metabolites have not yet been analyzed, data will be released upon assessment. | Not Posted | Dec 2024 | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. | Participants |
| Secondary | Bile Acids | Bile acid concentrations in blood and feces, will be measured by ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry, and expressed as mean change over time from baseline. | Not Posted | Dec 2024 | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. | Participants |
| Secondary | Gut Inflammation | Fecal calprotectin, a protein associated with gut inflammation and irritable gut syndrome, will be measured by enzyme-linked immunosorbent assay, and expressed as mean change over time from baseline. | Posted | Mean | Standard Deviation | microgram per milligram (ug/mg) | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
|
|
|
| Secondary | Aspartate Aminotransferase (AST) | Aspartate aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline. | Posted | Mean | Standard Deviation | milligrams per deciliter (mgdL) | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
|
|
|
| Secondary | Alanine Aminotransferase (ALT) | Alanine aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline. | Posted | Mean | Standard Deviation | milligrams per decileter (mg/dL) | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
|
|
|
| Secondary | Gamma-Glutamyl Transferase (GGT) | Gamma-glutamyl transferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline. | Posted | Mean | Standard Deviation | milligrams per decileter (mg/dL) | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks |
|
|
|
| Secondary | Estimated Glomerular Filtration Rate | Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice. Reported as mean change from baseline. | Posted | Mean | Standard Deviation | millileters per minute (mL/min) | 2 weeks, 4 weeks, 6 weeks, and 8 weeks |
|
|
|
| Secondary | Blood Urea Nitrogen to Creatinine Ratio | Blood urea nitrogen (BUN) : creatinine (Cr) is a ratio of serum concentrations of two compounds associated with renal function. Reported as mean change from baseline. | Posted | Mean | Standard Deviation | Ratio of BUN (mg/dL) to Cr (mg/dL) | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
|
|
|
| Secondary | Complete Blood Count Abnormals | Enumeration of the various subtypes of blood cells (i.e., red blood cells, white blood cells, and platelets), plus indices including mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), and hematocrit. Reported as: % abnormal (i.e., number of participants with an abnormal value compared to the number of participants in the group) and % new abnormals if abnormal counts were noted. Abnormality is assessed according to standards for age and sex measurements under Quest Diagnostics criteria. | Posted | Number | participants | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
|
|
|
| Secondary | Total Red Blood Cell Count | Enumeration of total red blood cell count. Reported as mean change from baseline. | Posted | Mean | Standard Deviation | mean change from baseline | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
|
|
|
| Secondary | Total White Blood Cell Count | Enumeration of total white blood cell count. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8. | Posted | Mean | Standard Deviation | thousand cells per microliter (1000/uL) | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
|
|
|
| Secondary | Platelet Count | Enumeration of platelet count. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8. | Posted | Mean | Standard Deviation | thousand cells per microliter (1000/uL) | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
|
|
|
| Secondary | Mean Corpuscular Volume | Enumeration of mean corpuscular volume (MCV). Results are reported as mean change from baseline at weeks 2, 4, 6, and 8. | Posted | Mean | Standard Deviation | femtoliter (fL) | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
|
|
|
| Secondary | Mean Corpuscular Hemoglobin | Enumeration of mean corpuscular hemoglobin (MCH). Results are reported as mean change from baseline at weeks 2, 4, 6, and 8. | Posted | Mean | Standard Deviation | picograms (pg) | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
|
|
|
| Secondary | Hematocrit | Enumeration of hematocrit. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8. | Posted | Mean | Standard Deviation | percent (%) | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 14 |
| 16 |
| EG001 | Placebo Oral Capsule | Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal. Placebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal. | 0 | 14 | 0 | 14 | 12 | 14 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Allergy symptoms | General disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Decreased appetite | Gastrointestinal disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Dry eyes and periorbital twitching | Eye disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Increased thirst | General disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Headache | General disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Lethargy | General disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Insomnia | General disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Fatigue | General disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Hyperactivity | General disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Shortness of breath on exertion | Respiratory, thoracic and mediastinal disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Hypotension | Cardiac disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Chest pain | Respiratory, thoracic and mediastinal disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Peripheral edema/swelling | Vascular disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Itchy/dry skin | Skin and subcutaneous tissue disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Breast swelling | Reproductive system and breast disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Dizziness | General disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Sore throat | General disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Decreased urination | Renal and urinary disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| Fever | General disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
| General body pain | General disorders | NCI CTCAEv4.0 | Systematic Assessment |
|
Not provided
Not provided
| Week 4 Grade 1 |
|
| Week 4 Grade 2 |
|
| Week 6 Grade 1 |
|
| Week 6 Grade 2 |
|
| Week 8 Grade 1 |
|
| Week 8 Grade 2 |
|
| Urinary 6-PN: Week 4 |
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| Urinary 6-PN: Week 6 |
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| Urinary 6-PN: Week 8 |
|
| Urinary 8-Prenylnaringenin (8-PN): Baseline |
|
| Urinary 8-PN: Week 2 |
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| Urinary 8-PN: Week 4 |
|
| Urinary 8-PN: Week 6 |
|
| Urinary 8- PN Week 8 |
|
| Urinary Dihydroxanthohumol (DXN): Baseline |
|
| Urinary DXN: Week 2 |
|
| Urinary DXN: Week 4 |
|
| Urinary DXN: Week 6 |
|
| Urinary DXN: Week 8 |
|
| Urinary Desmethyldihydroxanthohumol (DDXN): Baseline |
|
| Urinary DDXN: Week 2 |
|
| Urinary DDXN: Week 4 |
|
| Urinary DDXN: Week 6 |
|
| Urinary DDXN: Week 8 |
|
| Urinary Isoxanthohumol (IXN): Baseline |
|
| Urinary IXN: Week 2 |
|
| Urinary IXN: Week 4 |
|
| Urinary IXN: Week 6 |
|
| Urinary IXN: Week 8 |
|
| Urinary Xanthohumol (XN) Baseline |
|
| Urinary XN: Week 2 |
|
| Urinary XN: Week 4 |
|
| Urinary XN: Week 6 |
|
| Urinary XN: Week 8 |
|
| Plasma 6-Prenylnaringenin (6PN): Baseline |
|
| Plasma 6-PN: Week 2 |
|
| Plasma 6-PN: Week 4 |
|
| Plasma 6-PN: Week 6 |
|
| Plasma 6-PN: Week 8 |
|
| Plasma 8-Prenylnaringenin: Baseline |
|
| Plasma 8-PN: Week 2 |
|
| Plasma 8-PN: Week 4 |
|
| Plasma 8-PN: Week 6 |
|
| Plasma 8-PN: Week 8 |
|
| Plasma Dihydroxanthohumol (DXN): Baseline |
|
| Plasma DXN: Week 2 |
|
| Plasma DXN: Week 4 |
|
| Plasma DXN: Week 6 |
|
| Plasma DXN: Week 8 |
|
| Plasma Desmethyldihydroxanthohumol (DDXN): Baseline |
|
| Plasma DDXN: Week 2 |
|
| Plasma DDXN: Week 4 |
|
| Plasma DDXN: Week 6 |
|
| Plasma DDXN: Week 8 |
|
| Plasma Isoxanthohumol (IXN): Baseline |
|
| Plasma IXN: Week 2 |
|
| Plasma IXN: Week 4 |
|
| Plasma IXN: Week 6 |
|
| Plasma IXN: Week 8 |
|
| Plasma Xanthohumol (XN): Baseline |
|
| Plasma XN: Week 2 |
|
| Plasma XN: Week 4 |
|
| Plasma XN: Week 6 |
|
| Plasma XN: Week 8 |
|
| Week 4 |
|
| Week 6 |
|
| Week 8 |
|
| Week 6 |
|
| Week 8 |
|
| Week 6 |
|
| Week 8 |
|
| Week 6 |
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| Week 8 |
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| Week 6 |
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| Week 8 |
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| Week 4 |
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| Week 6 |
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| Closeout |
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| Total Red Blood Cell Count (Week 8) : number of abnormal |
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| Total Red Blood Cell Count (Week 8) : number of new abnormals |
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| Mean Corpuscular Hemoglobin (Week 8) : number of abnormals |
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| Mean Corpuscular Hemoglobin (Week 8) : number of new abnormals |
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| Hemoglobin (Week 2) : number of abnormals |
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| Hemoglobin (Week 2) : number of new abnormals |
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| Hemoglobin (Week 4) : number of abnormals |
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| Hemoglobin (Week 4) : number of new abnormals |
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| Hemoglobin (Week 6) : number of abnormals |
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| Hemoglobin (Week 6) : number of new abnormals |
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| Hemoglobin (Week 8) : number of abnormals |
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| Hemoglobin (Week 8) : %new abnormals |
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| Total White Blood Cell Count (Week 2) : number of abnormals |
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| Total White Blood Cell Count (Week 2) : number of new abnormals |
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| Total White Blood Cell Count (Week 4) : number of abnormals |
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| Total White Blood Cell Count (Week 4) : number of new abnormals |
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| Total White Blood Cell Count (Week 6) : number of abnormals |
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| Total White Blood Cell Count (Week 6) : number of new abnormals |
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| Total White Blood Cell Count (Week 8) : number of abnormal |
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| Total White Blood Cell Count (Week 8) : %new abnormals |
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| Total Red Blood Cell Count (Week 6) |
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| Total Red Blood Cell Count (Week 8) |
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| Total White Blood Cell Count (Week 6) |
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| Total White Blood Cell Count (Week 8) |
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| Platelet Count (Week 6) |
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| Platelet Count (Week 8) |
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| Mean Corpuscular Volume (Week 6) |
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| Mean Corpuscular Volume (Week 8) |
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| Mean Corpuscular Hemoglobin (Week 6) |
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| Mean Corpuscular Hemoglobin (Week 8) |
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| Hematocrit (Week 6) |
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| Hematocrit (Week 8) |
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