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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Genistein followed by Placebo | Experimental | Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 |
|
| Arm B: Placebo followed by Genistein | Experimental | Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genistein | Drug | Estrogen-like compound (isoflavone) derived from soybeans |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment |
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Inclusion Criteria
Newly diagnosed solid tumor or lymphoma with histological verification
Age 1 - 21 years at time of diagnosis
Karnofsky/Lanksy performance score of ≥ 50
Able to tolerate enteral medication administration
Planned chemotherapeutic regimen for a patient must meet all of the following criteria:
Informed consent or parental permission and assent obtained prior to trial-related activities
Able and willing to comply with all study related procedures
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
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| Name | Affiliation | Role |
|---|---|---|
| William C. Petersen, Jr., M.D. | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Arm B: Placebo Followed by Genistein |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 30, 2017 |
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| Placebo | Drug | Pill that contains no medicine |
|
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis |
| 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 Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | This includes hearing loss/tinnitus, motor neuropathy, oral mucositis | 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 |
| 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 | 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 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 |
| 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 |
| 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 |
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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy | Posted | Mean | Standard Deviation | days | 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 |
|
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Serum Marker Levels of Inflammation Erythrocyte Sedimentation Rate (ESR; mm/hr) During Cycles of Chemotherapy | Posted | Mean | Standard Deviation | mm/hr | 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 |
|
| ||||||||||||||||||||||||||||||||||||||
| 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 | Posted | Mean | Full Range | days | 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 | Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment | This includes hearing loss/tinnitus, motor neuropathy, oral mucositis | Posted | Count of Participants | Participants | 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 | 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 | Posted | Mean | Full Range | Events | 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 | Number of Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event | Posted | Mean | Standard Deviation | days | 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 |
|
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| Secondary | Number of Days That Planned Cancer Treatment is Delayed Due to an Adverse Event | Posted | Mean | Full Range | days | 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 | Percentage of Participants Requiring Reduced Treatment Doses Due to an Adverse Event | Posted | Number | percentage of participants | 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 |
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| Secondary | Number of Days That Antimicrobial Treatment is Administered | Posted | Mean | Full Range | days | 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 |
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| Secondary | Number of Cycles Where Granulocyte-colony Stimulating Factor (G-CSF) is Administered | Posted | Number | cycles | 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 | cycles | cycles |
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| Secondary | Number of Times That a Blood Product is Administered for Anemia, Decreased Platelets, Abnormal Bleeding, or the Subject's Best Interest | Posted | Mean | Standard Deviation | transfusions | 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 |
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| Secondary | Serum Marker Levels of Inflammation C-reactive Protein (CRP; mg/dL) During Cycles of Chemotherapy | Posted | Mean | Standard Deviation | mg/dL | 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 |
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All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
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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 | Arm A: Genistein Followed by Placebo - GENISTEIN Cycles | 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 | 0 | 2 | 1 | 2 | 2 | 2 |
| EG001 | Arm B: Placebo Followed by Genistein - GENISTEIN Cycles | 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 | 1 | 2 | 1 | 2 | 2 | 2 |
| EG002 | Arm A: Genistein Followed by Placebo - PLACEBO Cycles | 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 | 0 | 2 | 1 | 2 | 0 | 2 |
| EG003 | Arm B: Placebo Followed by Genistein - PLACEBO Cycles | 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 | 0 | 2 | 1 | 2 | 0 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Anal mucositis | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| White blood cell count decreased | Investigations | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Peripheral sensory Neuropathy | Nervous system disorders | Systematic Assessment |
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| sinus tachycardia | Cardiac disorders | Systematic Assessment |
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| Prolonged QTC interval | Cardiac disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
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| Bladder infection | Immune system disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
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| Methemoglobinemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Eye infection | Infections and infestations | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Petersen | UVA Health | 434-924-8499 | wcp3g@uvahealth.org |
| Aug 4, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009447 | Neuroblastoma |
| D012512 | Sarcoma, Ewing |
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D012208 | Rhabdomyosarcoma |
| D012509 | Sarcoma |
| D008527 | Medulloblastoma |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009396 | Wilms Tumor |
| D001932 | Brain Neoplasms |
| D018242 | Neuroectodermal Tumors, Primitive |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D005910 | Glioma |
| D018193 | Neoplasms, Complex and Mixed |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019833 | Genistein |
| ID | Term |
|---|---|
| D007529 | Isoflavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG003 | Arm B: Placebo Followed by Genistein - PLACEBO Cycles | 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 |
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| OG003 | Arm B: Placebo Followed by Genistein - PLACEBO Cycles | 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 |
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| OG003 | Arm B: Placebo Followed by Genistein - PLACEBO Cycles | 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 |
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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 |
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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 |
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| cycles |
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