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Property:Exclusion criteria

From CAMIH

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A
previous history of peripheral neuropathy or with symptomatic peripheral neuropathy at entry into the study. We also excluded patients who had received other chemotherapy regimens (except 5-fluorouracil alone) and those currently receiving gabapentin, carbamazepine, amitriptyline, amifostine or multivitamins  +
Already taking a vitamin D supplement or active vitamin D; had a history of urinary tract stones; and other difficulties as judged by the surgeon in charge  +
History of previous malignancy or chemotherapy, history of other systemic diseases, metastatic condition or receiving other antiemetic drugs  +
Previous or simultaneous radiotherapy in the head and neck region, including the nasopharynx, oropharynx, and larynx; previous head and neck surgery due to malignancy; use of dentures; pregnancy; infection  +
History of peripheral neuropathy (i.e., hereditary, paraneoplastic, or associated with nutritional agents) and a history of systemic diseases (i.e., diabetes mellitus, SLE, HIV, alcohol abuse); excluded if they were not chemotherapy-naïve or if clinical or electrophysiological evidence of peripheral neuropathy was disclosed at baseline  +
History of peripheral neuropathy (i.e., hereditary, paraneoplastic, or associated with nutritional agents) and a history of systemic diseases (i.e., diabetes mellitus, SLE, HIV, alcohol abuse); excluded if they were not chemotherapy-naïve or if clinical or electrophysiological evidence of peripheral neuropathy was disclosed at baseline  +
Second malignancy within 5 years (excluding basal or squamous cell carcinoma of the skin treated curatively); brain metastasis; nephrolithiasis within 10 years; chronic hypercalcemia (i.e., serum calcium >1.0 mg/dL the upper limit of normal); chronic gastrointestinal disease (i.e., malabsorption, surgery affecting absorption, and chronic ulcerative colitis); urinary protein >4 g/24 h; urinary calcium ≥500 mg/24 h; active angina, New York Heart Association class II–IV heart failure, or history of myocardial infarction within 6 month; uncontrolled infection; or hypersensitivity to polysorbate 80, use of digitalis, thiazide diuretics, calcium supplements, anticonvulsants, fluoride, and lithium was not allowed, use of steroids was permitted unless taken for prostate cancer; treatment with suramin, strontium, or other therapeutic radioisotopesor radiotherapy within 4 weeks  +
Patients who were supposed to receive head and neck radiotherapy as part of their treatment, patients who were taking anticoagulant therapy, as some studies have shown that vitamin E may increase the bleeding tendency.  +
B
- Karnofsky performance score of less than 60 - multiple primary head and neck cancers or a history of cancer - severe cardiovascular disease - inadequate renal, hepatic, or hematologic function - anticoagulant therapy - pregnancy - average daily supplement intake of β-carotene or vitamin E in the preceding year greater than 6.0 mg and 50 IU, respectively  +
- Karnofsky performance score of less than 60 - multiple primary head and neck cancers or a history of cancer - severe cardiovascular disease - inadequate renal, hepatic, or hematologic function - anticoagulant therapy - pregnancy - average daily supplement intake of β-carotene or vitamin E in the preceding year greater than 6.0 mg and 50 IU, respectively  +
- Karnofsky performance score of less than 60 - multiple primary head and neck cancers or a history of cancer - severe cardiovascular disease - inadequate renal, hepatic, or hematologic function - anticoagulant therapy - pregnancy - average daily supplement intake of β-carotene or vitamin E in the preceding year greater than 6.0 mg and 50 IU, respectively  +
Current or planned therapy with chemotherapy, androgens, estrogens, progestational agents, corticosteroids, or other agents used for treating hot flashes, intake of two multivitamin tablets per day or over 60 IU of vitamin E daily, pregnant or lactating women could not participate, nor could those with a history of bleeding tendencies, immune deficiencies, or thrombophlebitis  +
Use of Ginkgo biloba in the last 6 months; antithrombotic therapy; significant concomitant diseases, e.g. diabetes  +
Active malignancy within 5 years (except nonmelanoma skin cancer), significant active medical illness that would preclude protocol treatment, a history of hypercalcemia or vitamin D toxicity, or hospitalization for treatment of angina, myocardial infarction, or congestive heart failure in the previous 12 months; kidney stones (calcium salt) within 5 years, hypersensitivity to calcitriol or drugs formulated with polysorbate-80, grade 2 or higher peripheral neuropathy, neutrophil count less than 1,500/mm<sup>3</sup> , platelet count lower than 100,000/ mm<sup>3</sup> , serum creatinine more than upper limit of normal (ULN), serum calcium more than ULN, conjugated bilirubin more than ULN, alkaline phosphatase more than 4 x ULN (patients with known bone involvement and a normal conjugated bilirubin, ALT, and AST were not excluded), ALT or AST more than 2.0 x ULN when alkaline phosphatase is less than 2.5 x ULN, ALT or AST more than 1.5 x ULN when alkaline phosphatase is more than 2.5 x ULN, prior investigational therapy or use of calcitriol within 30 days, prior chemotherapy for prostate cancer except for adjuvant therapy more than 12 months before enrollment, prior chemotherapy with docetaxel, treatment with radiotherapy within 4 weeks or treatment with other radiopharmaceuticals within 8 weeks  +
Patients with symptomatic brain metastases; - scheduled to receive or having received, in the past 4 weeks, radiotherapy to upper abdomen or craniospinal region; - emesis or significant nausea within 24h before the first HEC cycle; - coagulation disorders or current therapy with oral anticoagulants; - planned surgery during the study period or within 2 weeks after its conclusion; - prior seizures; - cannabinoids or current/past drug or alcohol abuse; - use of other investigational drug(s) within 30 days before study entry or during the study; - any relevant condition potentially interfering with study evaluation; - known hypersensitivity to ginger or any components of the product.  +
History of autoimmune disease, chronic inflammatory disease, active infectious diseases, liver or kidney disease, use of immunosuppressive drugs, or supplements containing zinc or copper, and chemotherapy or radiotherapy within 12 months before the study  +
Previous treatment for HFS; hypersensitivity to pyridoxine; immunosuppression or positive human immunodefciency virus (HIV) serology  +