{
    "info": {
        "nct_id": "NCT01262560",
        "official_title": "Phase II Randomized Trial of Prophylactic Manuka Honey for the Reduction of Chemoradiation Therapy Induced Esophagitis-Related Pain During the Treatment of Lung Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Patients being treated with combination chemotherapy (definitive or adjuvant) and radiation therapy once daily for small cell or non-small cell lung cancer (primary population for the trial)\n\n  * Patients can receive chemoradiotherapy while on a Radiation Therapy Oncology Group (RTOG) lung trial or while not being on a clinical trial\n  * No patients receiving chemoradiotherapy while enrolled on a single institution trial or trials coordinated by other cooperative groups\n* No patients with metastatic disease\n* At least 5 cm of the esophagus must be in the 60 Gy isodose volume in 1.6 to 2.0 Gy fractions\n\nPATIENT CHARACTERISTICS:\n\n* Age 18 and up\n* Able to swallow thick liquids prior to treatment\n* Able to speak English or Spanish in order to complete required forms (verbal completion is adequate)\n* No patients with poorly controlled diabetes\n* No known hypersensitivity to honey\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No patients who have received prior chemotherapy or radiation therapy\n* No patients receiving more than once daily treatments\n* Therapeutic use of honey other than the Manuka honey provided for this trial is not allowed while patients are on study\n* Patients must also avoid honey-flavored medical products and/or sugary, viscous substances\n* Amifostine is not permitted"
    },
    "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": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Patients being treated with combination chemotherapy (definitive or adjuvant) and radiation therapy once daily for small cell or non-small cell lung cancer (primary population for the trial)",
            "criterions": [
                {
                    "exact_snippets": "Patients being treated with combination chemotherapy",
                    "criterion": "combination chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation therapy once daily",
                    "criterion": "radiation therapy frequency",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "once daily"
                        }
                    ]
                },
                {
                    "exact_snippets": "small cell or non-small cell lung cancer",
                    "criterion": "lung cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "small cell",
                                "non-small cell"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients can receive chemoradiotherapy while on a Radiation Therapy Oncology Group (RTOG) lung trial or while not being on a clinical trial",
            "criterions": [
                {
                    "exact_snippets": "Patients can receive chemoradiotherapy",
                    "criterion": "chemoradiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "while on a Radiation Therapy Oncology Group (RTOG) lung trial",
                    "criterion": "RTOG lung trial participation",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "while not being on a clinical trial",
                    "criterion": "clinical trial participation",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No patients receiving chemoradiotherapy while enrolled on a single institution trial or trials coordinated by other cooperative groups",
            "criterions": [
                {
                    "exact_snippets": "No patients receiving chemoradiotherapy",
                    "criterion": "chemoradiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "enrolled on a single institution trial",
                    "criterion": "enrollment in a single institution trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "trials coordinated by other cooperative groups",
                    "criterion": "enrollment in trials coordinated by other cooperative groups",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No patients with metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "No patients with metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 5 cm of the esophagus must be in the 60 Gy isodose volume in 1.6 to 2.0 Gy fractions",
            "criterions": [
                {
                    "exact_snippets": "At least 5 cm of the esophagus must be in the 60 Gy isodose volume",
                    "criterion": "esophagus in 60 Gy isodose volume",
                    "requirements": [
                        {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "1.6 to 2.0 Gy fractions",
                    "criterion": "fraction size",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1.6,
                                        "unit": "Gy"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2.0,
                                        "unit": "Gy"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age 18 and up",
            "criterions": [
                {
                    "exact_snippets": "Age 18 and up",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to swallow thick liquids prior to treatment",
            "criterions": [
                {
                    "exact_snippets": "Able to swallow thick liquids",
                    "criterion": "ability to swallow thick liquids",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to speak English or Spanish in order to complete required forms (verbal completion is adequate)",
            "criterions": [
                {
                    "exact_snippets": "Able to speak English or Spanish",
                    "criterion": "language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "languages",
                            "expected_value": [
                                "English",
                                "Spanish"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "complete required forms (verbal completion is adequate)",
                    "criterion": "form completion ability",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "verbal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No patients with poorly controlled diabetes",
            "criterions": [
                {
                    "exact_snippets": "No patients with poorly controlled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "not poorly controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known hypersensitivity to honey",
            "criterions": [
                {
                    "exact_snippets": "No known hypersensitivity to honey",
                    "criterion": "hypersensitivity to honey",
                    "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": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "See Disease Characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No patients who have received prior chemotherapy or radiation therapy",
            "criterions": [
                {
                    "exact_snippets": "No patients who have received prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No patients who have received prior ... radiation therapy",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No patients receiving more than once daily treatments",
            "criterions": [
                {
                    "exact_snippets": "No patients receiving more than once daily treatments",
                    "criterion": "treatment frequency",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "times per day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Therapeutic use of honey other than the Manuka honey provided for this trial is not allowed while patients are on study",
            "criterions": [
                {
                    "exact_snippets": "Therapeutic use of honey other than the Manuka honey provided for this trial is not allowed",
                    "criterion": "therapeutic use of honey",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "Manuka honey provided for this trial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must also avoid honey-flavored medical products and/or sugary, viscous substances",
            "criterions": [
                {
                    "exact_snippets": "avoid honey-flavored medical products",
                    "criterion": "honey-flavored medical products",
                    "requirements": [
                        {
                            "requirement_type": "avoidance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "avoid ... sugary, viscous substances",
                    "criterion": "sugary, viscous substances",
                    "requirements": [
                        {
                            "requirement_type": "avoidance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Amifostine is not permitted",
            "criterions": [
                {
                    "exact_snippets": "Amifostine is not permitted",
                    "criterion": "Amifostine",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        }
    ]
}