Brain Neoplasms, Childhood Lymphoma, Childhood Solid Tumor, Ewing Sarcoma, Germ Cell Tumor, Hodgkin Lymphoma, Lymphoma, Medulloblastoma, Medulloblastoma, Childhood, Neuroblastoma, Neuroectodermal Tumors, Primitive, Non-Hodgkin Lymphoma, Rhabdomyosarcoma, Soft Tissue Sarcoma, Solid Tumor, Wilms Tumor
Conditions
Keywords
Genistein, Soy, Chemotherapy side-effects, Pediatric Cancer, Isoflavone
Brief summary
Toxicities related to pediatric cancer treatment can lead to significant illness, organ damage, treatment delays, increased health care cost, and decrease in quality of life. Such toxicities are largely due to tissue damage sustained by chemotherapy, and strategies designed to limit such cellular damage to normal tissues may reduce therapy-related morbidity and mortality. In addition to their in vitro and in vivo anti-cancer effects, naturally occurring soy isoflavones have anti-inflammatory and anti-oxidant properties, and have been shown to reduce side effects of therapy in adult oncology clinical trials. This study will examine the effect of genistein, the major isoflavone component in soybeans and the most extensively studied of the soy isoflavones, on short-term side effects of myelosuppressive chemotherapy in pediatric cancer patients. Subjects will be randomized to receive either: a) 30 mg genistein daily throughout chemotherapy Cycles 1 and 2 and placebo during chemotherapy Cycles 3 and 4; or b) placebo daily during chemotherapy Cycles 1 and 2 and 30 mg genistein daily during chemotherapy Cycles 3 and 4. Investigators hypothesize that subjects will have fewer short-term therapy-related side effects during cycles of chemotherapy given in conjunction with genistein supplementation than cycles given with placebo.
Detailed description
This is a multi-center, randomized, double blind, placebo-controlled crossover study to evaluate the effect of soy isoflavones on the short term untoward effects of myelosuppressive chemotherapy used to treat pediatric cancers. Newly diagnosed cancer patients aged 1-21 years will be registered to the study and informed consent will be obtained prior to any study-related procedures. Stratification will be based on length of chemotherapy cycles, between 14 day and 21 day cycles. Within strata registered subjects will be randomized 1:1 to one of two schedules: Arm A: Subjects will receive genistein daily throughout chemotherapy cycles 1 and 2, and placebo during chemotherapy cycles 3 and 4 Arm B: Subjects will receive placebo daily throughout chemotherapy cycles 1 and 2, and genistein during chemotherapy cycles 3 and 4 Subjects will be assessed for safety and efficacy during each cycle with clinical labs, cytokine panels, and physical exams. Drug compliance will be monitored by use of a patient diary as well as monitoring of serum genistein levels. Adverse events will be monitored starting on Cycle 1 Day 1 through 30 days following the last day of protocol therapy (genistein/placebo).
Interventions
DRUGGenistein
Estrogen-like compound (isoflavone) derived from soybeans
DRUGPlacebo
Pill that contains no medicine
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
1. Newly diagnosed solid tumor or lymphoma with histological verification 2. Age 1 - 21 years at time of diagnosis 3. Karnofsky/Lanksy performance score of ≥ 50 4. Able to tolerate enteral medication administration 5. Planned chemotherapeutic regimen for a patient must meet all of the following criteria: * A known myelosuppressive regimen which includes at least two of the following agents: actinomycin, carboplatin, cisplatin, cyclophosphamide, daunorubicin, doxorubicin, etoposide, ifosfamide, topotecan * At least four consecutive cycles * Cycle length is either 14 or 21 days * Regimen must either alternate myelosuppressive chemotherapeutic agents in an X-Y-X-Y format, such that the same chemotherapy is given every other cycle (e.g. vincristine/doxorubicin/cyclophosphamide │ ifosfamide/etoposide), or repeat the same chemotherapeutic agents each cycle in an X-X-X-X format (e.g. repeated cycles of cisplatin/etoposide/bleomycin). Courses eligible for this trial may occur at any time during treatment provided that they are consecutive and follow the one of the described patterns. Non-myelosuppressive anti-neoplastic treatments will not be considered for the purposes of determining eligibility. Questions regarding whether or not a patient's chemotherapy plan meets inclusion criteria will be decided by the Study Chair. 6. Informed consent or parental permission and assent obtained prior to trial-related activities 7. Able and willing to comply with all study related procedures 8. Women of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Exclusion criteria
1. Known allergy to soy or any soy-based food or supplement 2. Unable or unwilling to discontinue consuming prohibited soy-based food or supplements while participating in this study 3. Pre-existing neutropenia or neutrophil qualitative or quantitative disorder 4. Pre-existing cytopenia or bone marrow failure syndrome 5. History of gastric or duodenal ulcers or hyperacidity syndromes 6. History of Human Immunodeficiency Virus (HIV) 7. Has an active infection requiring systemic therapy 8. Planned treatment does not include myelosuppressive chemotherapy 9. Enrolled on a therapeutic or supportive care clinical trial within the last 30 days 10. Current acute or chronic leukemia diagnosis 11. Requires medication dosing via an enteral feeding tube that terminates in the duodenum or jejunum. (Enteral feeding tubes that terminate in the stomach are acceptable for study medication delivery.) 12. Pregnant or breastfeeding woman 13. Incarceration 14. Secondary malignancy, i.e. the cancer for which the patient is presently or will be receiving treatment may not be a malignancy related to prior cancer therapy 15. Any condition which might be worsened by estrogen, such as breast cancer, uterine cancer, ovarian cancer, endometriosis or uterine fibroids 16. Any condition, in the investigator's opinion, that would compromise patient safety or study outcomes 17. Anyone who, in the investigator's discretion, would be unwilling or unable to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy | From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days That Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays | This includes hearing loss/tinnitus, motor neuropathy, oral mucositis |
| Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays | This includes hearing loss/tinnitus, motor neuropathy, oral mucositis |
| Severity of Adverse Events That Are Commonly Caused by Chemotherapy Treatment Based on CTCAE Severity Criteria | From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays | This includes hearing loss/tinnitus, motor neuropathy, oral mucositis |
| Number of Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event | From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays | — |
| Number of Days That Planned Cancer Treatment is Delayed Due to an Adverse Event | From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays | — |
| Serum Marker Levels of Inflammation Erythrocyte Sedimentation Rate (ESR; mm/hr) During Cycles of Chemotherapy | Once before treatment starts and then four more times while the study drug is being taken, an 8 - 16 week period if there are no chemotherapy delays | — |
| Number of Days That Antimicrobial Treatment is Administered | From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays | — |
| Number of Cycles Where Granulocyte-colony Stimulating Factor (G-CSF) is Administered | From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays | — |
| Number of Times That a Blood Product is Administered for Anemia, Decreased Platelets, Abnormal Bleeding, or the Subject's Best Interest | From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays | — |
| Serum Marker Levels of Inflammation C-reactive Protein (CRP; mg/dL) During Cycles of Chemotherapy | Once before treatment starts and then four more times while the study drug is being taken, an 8 - 16 week period if there are no chemotherapy delays | — |
| Percentage of Participants Requiring Reduced Treatment Doses Due to an Adverse Event | From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A: Genistein Followed by Placebo Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine | 2 |
| Arm B: Placebo Followed by Genistein Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Arm B: Placebo Followed by Genistein | Total | Arm A: Genistein Followed by Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10 years | 12 years | 14 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 2 Participants |
| Region of Enrollment United States | 2 participants | 4 participants | 2 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 1 / 2 | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 2 / 2 | 2 / 2 | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 1 / 2 | 1 / 2 | 1 / 2 | 1 / 2 |
Outcome results
Primary
Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A: Genistein Followed by Placebo | Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy | Genistein cycles | 13.75 days | Standard Deviation 1.26 |
| Arm A: Genistein Followed by Placebo | Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy | Placebo cycles | 15.5 days | Standard Deviation 1.73 |
| Arm B: Placebo Followed by Genistein | Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy | Genistein cycles | 12.67 days | Standard Deviation 2.08 |
| Arm B: Placebo Followed by Genistein | Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy | Placebo cycles | 13.5 days | Standard Deviation 2.12 |
Secondary
Number of Cycles Where Granulocyte-colony Stimulating Factor (G-CSF) is Administered
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Genistein Followed by Placebo | Number of Cycles Where Granulocyte-colony Stimulating Factor (G-CSF) is Administered | Genistein cycles | 2 cycles |
| Arm A: Genistein Followed by Placebo | Number of Cycles Where Granulocyte-colony Stimulating Factor (G-CSF) is Administered | Placebo cycles | 0 cycles |
| Arm B: Placebo Followed by Genistein | Number of Cycles Where Granulocyte-colony Stimulating Factor (G-CSF) is Administered | Genistein cycles | 0 cycles |
| Arm B: Placebo Followed by Genistein | Number of Cycles Where Granulocyte-colony Stimulating Factor (G-CSF) is Administered | Placebo cycles | 0 cycles |
Secondary
Number of Days That Antimicrobial Treatment is Administered
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Genistein Followed by Placebo | Number of Days That Antimicrobial Treatment is Administered | Genistein cycles | 0 days |
| Arm A: Genistein Followed by Placebo | Number of Days That Antimicrobial Treatment is Administered | Placebo cycles | 0 days |
| Arm B: Placebo Followed by Genistein | Number of Days That Antimicrobial Treatment is Administered | Genistein cycles | 0 days |
| Arm B: Placebo Followed by Genistein | Number of Days That Antimicrobial Treatment is Administered | Placebo cycles | 5 days |
Secondary
Number of Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A: Genistein Followed by Placebo | Number of Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event | Genistein cycles | 0.75 days | Standard Deviation 0.5 |
| Arm A: Genistein Followed by Placebo | Number of Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event | Placebo cycles | 0.5 days | Standard Deviation 0.58 |
| Arm B: Placebo Followed by Genistein | Number of Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event | Genistein cycles | 0.5 days | Standard Deviation 0.58 |
| Arm B: Placebo Followed by Genistein | Number of Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event | Placebo cycles | 0.25 days | Standard Deviation 0.5 |
Secondary
Number of Days That Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Genistein Followed by Placebo | Number of Days That Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | Genistein Cycles | 0 days |
| Arm A: Genistein Followed by Placebo | Number of Days That Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | Placebo Cycles | 0 days |
| Arm B: Placebo Followed by Genistein | Number of Days That Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | Placebo Cycles | 0 days |
| Arm B: Placebo Followed by Genistein | Number of Days That Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | Genistein Cycles | 0 days |
| Arm A: Genistein Followed by Placebo - PLACEBO Cycles | Number of Days That Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | Genistein Cycles | 0 days |
| Arm A: Genistein Followed by Placebo - PLACEBO Cycles | Number of Days That Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | Placebo Cycles | 0 days |
| Arm B: Placebo Followed by Genistein - PLACEBO Cycles | Number of Days That Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | Genistein Cycles | 0 days |
| Arm B: Placebo Followed by Genistein - PLACEBO Cycles | Number of Days That Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | Placebo Cycles | 0 days |
Secondary
Number of Days That Planned Cancer Treatment is Delayed Due to an Adverse Event
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Genistein Followed by Placebo | Number of Days That Planned Cancer Treatment is Delayed Due to an Adverse Event | Genistein Cycles | 0 days |
| Arm A: Genistein Followed by Placebo | Number of Days That Planned Cancer Treatment is Delayed Due to an Adverse Event | Placebo Cycles | 0 days |
| Arm B: Placebo Followed by Genistein | Number of Days That Planned Cancer Treatment is Delayed Due to an Adverse Event | Placebo Cycles | 0 days |
| Arm B: Placebo Followed by Genistein | Number of Days That Planned Cancer Treatment is Delayed Due to an Adverse Event | Genistein Cycles | 0 days |
| Arm A: Genistein Followed by Placebo - PLACEBO Cycles | Number of Days That Planned Cancer Treatment is Delayed Due to an Adverse Event | Genistein Cycles | 0 days |
| Arm A: Genistein Followed by Placebo - PLACEBO Cycles | Number of Days That Planned Cancer Treatment is Delayed Due to an Adverse Event | Placebo Cycles | 0 days |
| Arm B: Placebo Followed by Genistein - PLACEBO Cycles | Number of Days That Planned Cancer Treatment is Delayed Due to an Adverse Event | Genistein Cycles | 0 days |
| Arm B: Placebo Followed by Genistein - PLACEBO Cycles | Number of Days That Planned Cancer Treatment is Delayed Due to an Adverse Event | Placebo Cycles | 0 days |
Secondary
Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Genistein Followed by Placebo | Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | Genistein Cycles | 0 Participants |
| Arm A: Genistein Followed by Placebo | Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | Placebo Cycles | 0 Participants |
| Arm B: Placebo Followed by Genistein | Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | Placebo Cycles | 0 Participants |
| Arm B: Placebo Followed by Genistein | Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | Genistein Cycles | 0 Participants |
| Arm A: Genistein Followed by Placebo - PLACEBO Cycles | Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | Genistein Cycles | 0 Participants |
| Arm A: Genistein Followed by Placebo - PLACEBO Cycles | Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | Placebo Cycles | 0 Participants |
| Arm B: Placebo Followed by Genistein - PLACEBO Cycles | Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | Genistein Cycles | 0 Participants |
| Arm B: Placebo Followed by Genistein - PLACEBO Cycles | Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | Placebo Cycles | 0 Participants |
Secondary
Number of Times That a Blood Product is Administered for Anemia, Decreased Platelets, Abnormal Bleeding, or the Subject's Best Interest
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A: Genistein Followed by Placebo | Number of Times That a Blood Product is Administered for Anemia, Decreased Platelets, Abnormal Bleeding, or the Subject's Best Interest | Genistein cycles | 0.75 transfusions | Standard Deviation 0.96 |
| Arm A: Genistein Followed by Placebo | Number of Times That a Blood Product is Administered for Anemia, Decreased Platelets, Abnormal Bleeding, or the Subject's Best Interest | Placebo cycles | 1.25 transfusions | Standard Deviation 0.5 |
| Arm B: Placebo Followed by Genistein | Number of Times That a Blood Product is Administered for Anemia, Decreased Platelets, Abnormal Bleeding, or the Subject's Best Interest | Genistein cycles | 1.00 transfusions | Standard Deviation 1.15 |
| Arm B: Placebo Followed by Genistein | Number of Times That a Blood Product is Administered for Anemia, Decreased Platelets, Abnormal Bleeding, or the Subject's Best Interest | Placebo cycles | 0.75 transfusions | Standard Deviation 0.96 |
Secondary
Percentage of Participants Requiring Reduced Treatment Doses Due to an Adverse Event
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Genistein Followed by Placebo | Percentage of Participants Requiring Reduced Treatment Doses Due to an Adverse Event | 0 percentage of participants |
| Arm B: Placebo Followed by Genistein | Percentage of Participants Requiring Reduced Treatment Doses Due to an Adverse Event | 0 percentage of participants |
| Arm A: Genistein Followed by Placebo - PLACEBO Cycles | Percentage of Participants Requiring Reduced Treatment Doses Due to an Adverse Event | 0 percentage of participants |
| Arm B: Placebo Followed by Genistein - PLACEBO Cycles | Percentage of Participants Requiring Reduced Treatment Doses Due to an Adverse Event | 0 percentage of participants |
Secondary
Serum Marker Levels of Inflammation C-reactive Protein (CRP; mg/dL) During Cycles of Chemotherapy
Time frame: Once before treatment starts and then four more times while the study drug is being taken, an 8 - 16 week period if there are no chemotherapy delays
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A: Genistein Followed by Placebo | Serum Marker Levels of Inflammation C-reactive Protein (CRP; mg/dL) During Cycles of Chemotherapy | CRP, Genistein cycles | 0.37 mg/dL | Standard Deviation 0.29 |
| Arm A: Genistein Followed by Placebo | Serum Marker Levels of Inflammation C-reactive Protein (CRP; mg/dL) During Cycles of Chemotherapy | CRP, Placebo cycles | 0.33 mg/dL | Standard Deviation 0.26 |
| Arm B: Placebo Followed by Genistein | Serum Marker Levels of Inflammation C-reactive Protein (CRP; mg/dL) During Cycles of Chemotherapy | CRP, Genistein cycles | 0.13 mg/dL | Standard Deviation 0.05 |
| Arm B: Placebo Followed by Genistein | Serum Marker Levels of Inflammation C-reactive Protein (CRP; mg/dL) During Cycles of Chemotherapy | CRP, Placebo cycles | 0.15 mg/dL | Standard Deviation 0.1 |
Secondary
Serum Marker Levels of Inflammation Erythrocyte Sedimentation Rate (ESR; mm/hr) During Cycles of Chemotherapy
Time frame: Once before treatment starts and then four more times while the study drug is being taken, an 8 - 16 week period if there are no chemotherapy delays
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A: Genistein Followed by Placebo | Serum Marker Levels of Inflammation Erythrocyte Sedimentation Rate (ESR; mm/hr) During Cycles of Chemotherapy | ESR, Genistein cycles | 14.67 mm/hr | Standard Deviation 4.93 |
| Arm A: Genistein Followed by Placebo | Serum Marker Levels of Inflammation Erythrocyte Sedimentation Rate (ESR; mm/hr) During Cycles of Chemotherapy | ESR, Placebo cycles | 20.00 mm/hr | Standard Deviation 5.29 |
| Arm B: Placebo Followed by Genistein | Serum Marker Levels of Inflammation Erythrocyte Sedimentation Rate (ESR; mm/hr) During Cycles of Chemotherapy | ESR, Genistein cycles | 3.25 mm/hr | Standard Deviation 1.5 |
| Arm B: Placebo Followed by Genistein | Serum Marker Levels of Inflammation Erythrocyte Sedimentation Rate (ESR; mm/hr) During Cycles of Chemotherapy | ESR, Placebo cycles | 2.50 mm/hr | Standard Deviation 0.58 |
Secondary
Severity of Adverse Events That Are Commonly Caused by Chemotherapy Treatment Based on CTCAE Severity Criteria
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm A: Genistein Followed by Placebo | Severity of Adverse Events That Are Commonly Caused by Chemotherapy Treatment Based on CTCAE Severity Criteria | 0 Events |
| Arm B: Placebo Followed by Genistein | Severity of Adverse Events That Are Commonly Caused by Chemotherapy Treatment Based on CTCAE Severity Criteria | 0 Events |
| Arm A: Genistein Followed by Placebo - PLACEBO Cycles | Severity of Adverse Events That Are Commonly Caused by Chemotherapy Treatment Based on CTCAE Severity Criteria | 0 Events |
| Arm B: Placebo Followed by Genistein - PLACEBO Cycles | Severity of Adverse Events That Are Commonly Caused by Chemotherapy Treatment Based on CTCAE Severity Criteria | 0 Events |