{
"info": {
"nct_id": "NCT00064272",
"official_title": "Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed diagnosis of cancer\n* Currently receiving chemotherapy* containing any chemotherapeutic agent at any dose and experiencing nausea and/or vomiting of any severity (delayed or acute)\n\n * Chemotherapy regimens may be given orally, IV, or by continuous infusion (single day regimens only)\n* Must have received at least 1 prior chemotherapy* course containing any chemotherapeutic agent and meets the following criteria:\n\n * Agent is the same that is scheduled for the next round of chemotherapy\n * Experienced nausea and/or vomiting of any severity (delayed or acute)\n* Must be planning to receive a concurrent 5-HT_3 receptor antagonist antiemetic (e.g., ondansetron, granisetron, dolasetron mesylate, or palanosetron) or antiemetic aprepritant (e.g., Emend®) while on chemotherapy\n* No symptomatic brain metastases NOTE: *Chemotherapy may be adjuvant, neoadjuvant, curative, or palliative\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* No history of bleeding disorder\n* No thrombocytopenia\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nGastrointestinal\n\n* Able to swallow capsules\n* No gastric ulcer\n* No clinical evidence of current or impending bowel obstruction\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Able to understand English\n* Able to complete study questionnaires\n* No allergy to ginger\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* See Disease Characteristics\n* No prior chemotherapy regimens with multiple day doses\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No concurrent radiotherapy that is classified as high or intermediate risk of causing vomiting, including radiotherapy to any of the following areas:\n\n * Total body irradiation\n * Hemi-body\n * Upper abdomen\n * Abdominal-pelvic mantle\n * Cranium (radiosurgery)\n * Craniospinal radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* More than 1 week since prior ginger (teas, capsules, tinctures)\n* No other concurrent ginger (teas, capsules, tinctures)\n\n * Concurrent foods made with small amounts (no more than ¼ teaspoon) of ginger (powdered or fresh) allowed\n* No concurrent therapeutic-doses of warfarin, aspirin, or heparin\n\n * Concurrent low-dose warfarin to maintain peripheral or central venous access, low-dose aspirin (≤ 81 mg), or low-dose heparin allowed"
},
"inclusion_lines": [
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 120 Years",
"criterions": [
{
"exact_snippets": "maximum age of 120 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 120,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"line": "DISEASE CHARACTERISTICS:",
"criterions": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Histologically confirmed diagnosis of cancer",
"criterions": [
{
"exact_snippets": "Histologically confirmed diagnosis of cancer",
"criterion": "cancer diagnosis",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
]
}
]
},
{
"line": "* Currently receiving chemotherapy* containing any chemotherapeutic agent at any dose and experiencing nausea and/or vomiting of any severity (delayed or acute)",
"criterions": [
{
"exact_snippets": "Currently receiving chemotherapy",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "experiencing nausea and/or vomiting",
"criterion": "nausea and/or vomiting",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Chemotherapy regimens may be given orally, IV, or by continuous infusion (single day regimens only)",
"criterions": [
{
"exact_snippets": "Chemotherapy regimens may be given orally",
"criterion": "chemotherapy administration route",
"requirements": [
{
"requirement_type": "allowed routes",
"expected_value": [
"orally"
]
}
]
},
{
"exact_snippets": "Chemotherapy regimens may be given ... IV",
"criterion": "chemotherapy administration route",
"requirements": [
{
"requirement_type": "allowed routes",
"expected_value": [
"IV"
]
}
]
},
{
"exact_snippets": "Chemotherapy regimens may be given ... by continuous infusion",
"criterion": "chemotherapy administration route",
"requirements": [
{
"requirement_type": "allowed routes",
"expected_value": [
"continuous infusion"
]
}
]
},
{
"exact_snippets": "single day regimens only",
"criterion": "chemotherapy regimen duration",
"requirements": [
{
"requirement_type": "duration",
"expected_value": "single day"
}
]
}
]
},
{
"line": "* Must have received at least 1 prior chemotherapy* course containing any chemotherapeutic agent and meets the following criteria:",
"criterions": [
{
"exact_snippets": "Must have received at least 1 prior chemotherapy* course",
"criterion": "prior chemotherapy course",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "course"
}
}
]
}
]
},
{
"line": "* Agent is the same that is scheduled for the next round of chemotherapy",
"criterions": [
{
"exact_snippets": "Agent is the same that is scheduled for the next round of chemotherapy",
"criterion": "chemotherapy agent",
"requirements": [
{
"requirement_type": "consistency",
"expected_value": "same as scheduled for next round"
}
]
}
]
},
{
"line": "* Experienced nausea and/or vomiting of any severity (delayed or acute)",
"criterions": [
{
"exact_snippets": "Experienced nausea and/or vomiting of any severity (delayed or acute)",
"criterion": "nausea",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Experienced nausea and/or vomiting of any severity (delayed or acute)",
"criterion": "vomiting",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Must be planning to receive a concurrent 5-HT_3 receptor antagonist antiemetic (e.g., ondansetron, granisetron, dolasetron mesylate, or palanosetron) or antiemetic aprepritant (e.g., Emend®) while on chemotherapy",
"criterions": [
{
"exact_snippets": "Must be planning to receive a concurrent 5-HT_3 receptor antagonist antiemetic (e.g., ondansetron, granisetron, dolasetron mesylate, or palanosetron)",
"criterion": "5-HT_3 receptor antagonist antiemetic",
"requirements": [
{
"requirement_type": "planned treatment",
"expected_value": true
}
]
},
{
"exact_snippets": "Must be planning to receive ... antiemetic aprepritant (e.g., Emend®)",
"criterion": "aprepitant antiemetic",
"requirements": [
{
"requirement_type": "planned treatment",
"expected_value": true
}
]
}
]
},
{
"line": "* No symptomatic brain metastases NOTE: *Chemotherapy may be adjuvant, neoadjuvant, curative, or palliative",
"criterions": [
{
"exact_snippets": "No symptomatic brain metastases",
"criterion": "symptomatic brain metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "Age",
"criterions": [
{
"exact_snippets": "Age",
"criterion": "age",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "* 18 and over",
"criterions": [
{
"exact_snippets": "18 and over",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "Performance status",
"criterions": [
{
"exact_snippets": "Performance status",
"criterion": "performance status",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "Life expectancy",
"criterions": [
{
"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "Hematopoietic",
"criterions": [
{
"exact_snippets": "Hematopoietic",
"criterion": "hematopoietic",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No history of bleeding disorder",
"criterions": [
{
"exact_snippets": "No history of bleeding disorder",
"criterion": "bleeding disorder",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
}
]
},
{
"line": "* No thrombocytopenia",
"criterions": [
{
"exact_snippets": "No thrombocytopenia",
"criterion": "thrombocytopenia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "Hepatic",
"criterions": [
{
"exact_snippets": "Hepatic",
"criterion": "hepatic function",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Renal",
"criterions": [
{
"exact_snippets": "Renal",
"criterion": "renal function",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Gastrointestinal",
"criterions": [
{
"exact_snippets": "Gastrointestinal",
"criterion": "gastrointestinal condition",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Able to swallow capsules",
"criterions": [
{
"exact_snippets": "Able to swallow capsules",
"criterion": "ability to swallow capsules",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* No gastric ulcer",
"criterions": [
{
"exact_snippets": "No gastric ulcer",
"criterion": "gastric ulcer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No clinical evidence of current or impending bowel obstruction",
"criterions": [
{
"exact_snippets": "No clinical evidence of current or impending bowel obstruction",
"criterion": "bowel obstruction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Negative pregnancy test",
"criterions": [
{
"exact_snippets": "Negative pregnancy test",
"criterion": "pregnancy test",
"requirements": [
{
"requirement_type": "result",
"expected_value": "negative"
}
]
}
]
},
{
"line": "* Fertile patients must use effective contraception",
"criterions": [
{
"exact_snippets": "Fertile patients",
"criterion": "fertility",
"requirements": [
{
"requirement_type": "status",
"expected_value": "fertile"
}
]
},
{
"exact_snippets": "must use effective contraception",
"criterion": "contraception use",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
}
]
},
{
"line": "* Able to understand English",
"criterions": [
{
"exact_snippets": "Able to understand English",
"criterion": "English comprehension",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* Able to complete study questionnaires",
"criterions": [
{
"exact_snippets": "Able to complete study questionnaires",
"criterion": "ability to complete study questionnaires",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* No allergy to ginger",
"criterions": [
{
"exact_snippets": "No allergy to ginger",
"criterion": "allergy to ginger",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "PRIOR CONCURRENT THERAPY:",
"criterions": [
{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
"criterion": "prior concurrent therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Biologic therapy",
"criterions": [
{
"exact_snippets": "Biologic therapy",
"criterion": "biologic therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Chemotherapy",
"criterions": [
{
"exact_snippets": "Chemotherapy",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* See Disease Characteristics",
"criterions": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "see details"
}
]
}
]
},
{
"line": "* No prior chemotherapy regimens with multiple day doses",
"criterions": [
{
"exact_snippets": "No prior chemotherapy regimens with multiple day doses",
"criterion": "prior chemotherapy regimens",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
},
{
"requirement_type": "dose schedule",
"expected_value": "multiple day doses"
}
]
}
]
},
{
"line": "Endocrine therapy",
"criterions": [
{
"exact_snippets": "Endocrine therapy",
"criterion": "endocrine therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Radiotherapy",
"criterions": [
{
"exact_snippets": "Radiotherapy",
"criterion": "radiotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No concurrent radiotherapy that is classified as high or intermediate risk of causing vomiting, including radiotherapy to any of the following areas:",
"criterions": [
{
"exact_snippets": "No concurrent radiotherapy that is classified as high or intermediate risk of causing vomiting",
"criterion": "concurrent radiotherapy",
"requirements": [
{
"requirement_type": "risk classification",
"expected_value": [
"not high",
"not intermediate"
]
}
]
},
{
"exact_snippets": "radiotherapy to any of the following areas",
"criterion": "radiotherapy areas",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Total body irradiation",
"criterions": [
{
"exact_snippets": "Total body irradiation",
"criterion": "total body irradiation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Hemi-body",
"criterions": [
{
"exact_snippets": "Hemi-body",
"criterion": "hemi-body",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Upper abdomen",
"criterions": [
{
"exact_snippets": "Upper abdomen",
"criterion": "upper abdomen",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Abdominal-pelvic mantle",
"criterions": [
{
"exact_snippets": "Abdominal-pelvic mantle",
"criterion": "abdominal-pelvic mantle",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Cranium (radiosurgery)",
"criterions": [
{
"exact_snippets": "Cranium (radiosurgery)",
"criterion": "cranium radiosurgery",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": true
}
]
}
]
},
{
"line": "* Craniospinal radiotherapy",
"criterions": [
{
"exact_snippets": "Craniospinal radiotherapy",
"criterion": "craniospinal radiotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Surgery",
"criterions": [
{
"exact_snippets": "Surgery",
"criterion": "surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* More than 1 week since prior ginger (teas, capsules, tinctures)",
"criterions": [
{
"exact_snippets": "More than 1 week since prior ginger (teas, capsules, tinctures)",
"criterion": "ginger consumption",
"requirements": [
{
"requirement_type": "time since last consumption",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "week"
}
}
]
}
]
},
{
"line": "* No other concurrent ginger (teas, capsules, tinctures)",
"criterions": [
{
"exact_snippets": "No other concurrent ginger (teas, capsules, tinctures)",
"criterion": "ginger consumption",
"requirements": [
{
"requirement_type": "concurrency",
"expected_value": false
}
]
}
]
},
{
"line": "* Concurrent foods made with small amounts (no more than ¼ teaspoon) of ginger (powdered or fresh) allowed",
"criterions": [
{
"exact_snippets": "Concurrent foods made with small amounts (no more than ¼ teaspoon) of ginger (powdered or fresh) allowed",
"criterion": "ginger in concurrent foods",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 0.25,
"unit": "teaspoon"
}
}
]
}
]
},
{
"line": "* No concurrent therapeutic-doses of warfarin, aspirin, or heparin",
"criterions": [
{
"exact_snippets": "No concurrent therapeutic-doses of warfarin",
"criterion": "warfarin",
"requirements": [
{
"requirement_type": "concurrent therapeutic-dose",
"expected_value": false
}
]
},
{
"exact_snippets": "No concurrent therapeutic-doses of ... aspirin",
"criterion": "aspirin",
"requirements": [
{
"requirement_type": "concurrent therapeutic-dose",
"expected_value": false
}
]
},
{
"exact_snippets": "No concurrent therapeutic-doses of ... heparin",
"criterion": "heparin",
"requirements": [
{
"requirement_type": "concurrent therapeutic-dose",
"expected_value": false
}
]
}
]
},
{
"line": "* Concurrent low-dose warfarin to maintain peripheral or central venous access, low-dose aspirin (≤ 81 mg), or low-dose heparin allowed",
"criterions": [
{
"exact_snippets": "Concurrent low-dose warfarin to maintain peripheral or central venous access ... allowed",
"criterion": "concurrent low-dose warfarin",
"requirements": [
{
"requirement_type": "allowance",
"expected_value": true
}
]
},
{
"exact_snippets": "low-dose aspirin (≤ 81 mg) ... allowed",
"criterion": "low-dose aspirin",
"requirements": [
{
"requirement_type": "allowance",
"expected_value": true
},
{
"requirement_type": "dosage",
"expected_value": {
"operator": "<=",
"value": 81,
"unit": "mg"
}
}
]
},
{
"exact_snippets": "low-dose heparin allowed",
"criterion": "low-dose heparin",
"requirements": [
{
"requirement_type": "allowance",
"expected_value": true
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"line": "PATIENT CHARACTERISTICS:",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "Other",
"criterions": []
},
{
"line": "* Not pregnant or nursing",
"criterions": [
{
"exact_snippets": "Not pregnant",
"criterion": "pregnancy status",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
},
{
"exact_snippets": "not ... nursing",
"criterion": "nursing status",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
}
]
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "Other",
"criterions": []
}
]
}