{"id":"c00a57ed-cf9e-57a5-b5cf-9a75c1f74fa1","stable_key":"cb568d28-484a-5c2e-9fcc-2d780358e514:c-iv-pancreas-survival-signal","predicate":"addition_to_chemotherapy_improved_survival_in_small_trial","statement":"Median overall survival was 16 versus 8.3 months with versus without added IV ascorbate (HR 0.46; 90% CI 0.23–0.92; P=0.030).","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"positive","is_public":true,"mechanism_event_id":"5448e1b6-15ba-5e2c-9fa9-3758684a8900","mechanism_event_label":"Adding the infusions to the two-drug regimen produced a promising survival signal in this small study.","subject":{"id":"38d0c4d9-53d1-5239-bfe3-c1b5e9b79085","slug":"ascorbate","display_name":"L-Ascorbate","entity_type_key":"small_molecule"},"object":{"id":"e34dfe99-dcac-5452-8dd3-4b90c0592057","slug":"pancreatic-cancer-overall-survival","display_name":"Overall survival in pancreatic cancer","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"5448e1b6-15ba-5e2c-9fa9-3758684a8900","stable_key":"cb568d28-484a-5c2e-9fcc-2d780358e514:c-iv-pancreas-survival-signal-event","event_type":"observed_intervention","label":"Adding the infusions to the two-drug regimen produced a promising survival signal in this small study.","description":"Median overall survival was 16 versus 8.3 months with versus without added IV ascorbate (HR 0.46; 90% CI 0.23–0.92; P=0.030).","status":"provisional","compartment":null,"participants":[{"entity":{"id":"2c2de575-1ed9-5397-bcc0-4ea15dadd47b","slug":"gemcitabine","display_name":"Gemcitabine","entity_type_key":"small_molecule"},"role":"cointervention","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"7407ae65-3b87-5824-b897-eafe80d518df","slug":"nab-paclitaxel","display_name":"Albumin-bound paclitaxel formulation","entity_type_key":"chemical_species"},"role":"cointervention","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""},{"entity":{"id":"38d0c4d9-53d1-5239-bfe3-c1b5e9b79085","slug":"ascorbate","display_name":"L-Ascorbate","entity_type_key":"small_molecule"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":2,"notes":""},{"entity":{"id":"e34dfe99-dcac-5452-8dd3-4b90c0592057","slug":"pancreatic-cancer-overall-survival","display_name":"Overall survival in pancreatic cancer","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":3,"notes":""}]},"contexts":[{"dimension":"experimental_model","value_text":"Unblinded randomized phase II metastatic pancreatic cancer trial at two academic sites: 36 randomized, 34 received assigned therapy and entered analysis.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"Gemcitabine and nab-paclitaxel with or without IV pharmacologic ascorbate 75 g three times weekly.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Small unblinded trial; a planned futility interim analysis was followed by efficacy-based closure supported by the monitoring committee, without a stated prespecified efficacy boundary. 34 treated/evaluable of 36 randomized, 90% rather than 95% intervals, one-sided design. Tumor redox mediators were not measured; requires confirmation and does not support replacing chemotherapy.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Vitamin C research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"vitamin-c","display_name":"Vitamin C","entity_type_key":"chemical_species"}},{"dimension":"organism","value_text":"Homo sapiens","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"Adding the infusions to the two-drug regimen produced a promising survival signal in this small study.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[c-bodeker2024] A randomized trial of pharmacological ascorbate, gemcitabine, and nab-paclitaxel for metastatic pancreatic cancer (2024). https://pubmed.ncbi.nlm.nih.gov/39369582/ DOI: 10.1016/j.redox.2024.103375","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue_or_cell_type","value_text":"Human blood or whole-person endpoints","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"4d473be1-310e-5e6a-96e5-c1d586fbbd0e","evidence_kind":"source_excerpt","locator":"Lines 1806-1816","start_line":1806,"end_line":1816,"excerpt":"### c-iv-pancreas-survival-signal\nMedian overall survival was 16 versus 8.3 months with versus without added IV ascorbate (HR 0.46; 90% CI 0.23–0.92; P=0.030).\nCondition category: normal\nnutrient_topic: Vitamin C research collection; topical membership is not evidence of a direct dietary effect.\nplain_language: Adding the infusions to the two-drug regimen produced a promising survival signal in this small study.\norganism: Homo sapiens\ntissue_or_cell_type: Human blood or whole-person endpoints\nexperimental_model: Unblinded randomized phase II metastatic pancreatic cancer trial at two academic sites: 36 randomized, 34 received assigned therapy and entered analysis.\nlimitations: Small unblinded trial; a planned futility interim analysis was followed by efficacy-based closure supported by the monitoring committee, without a stated prespecified efficacy boundary. 34 treated/evaluable of 36 randomized, 90% rather than 95% intervals, one-sided design. Tumor redox mediators were not measured; requires confirmation and does not support replacing chemotherapy.\nexposure: Gemcitabine and nab-paclitaxel with or without IV pharmacologic ascorbate 75 g three times weekly.\n[c-bodeker2024] A randomized trial of pharmacological ascorbate, gemcitabine, and nab-paclitaxel for metastatic pancreatic cancer (2024). https://pubmed.ncbi.nlm.nih.gov/39369582/ DOI: 10.1016/j.redox.2024.103375","model_system":"Unblinded randomized phase II metastatic pancreatic cancer trial at two academic sites: 36 randomized, 34 received assigned therapy and entered analysis.","directness":"author_interpretation","verification_status":"source_derived_draft","notes":"Exact curation-document quotation, not publisher quotation. Study references: [c-bodeker2024] A randomized trial of pharmacological ascorbate, gemcitabine, and nab-paclitaxel for metastatic pancreatic cancer (2024). https://pubmed.ncbi.nlm.nih.gov/39369582/ DOI: 10.1016/j.redox.2024.103375","relationship":"supports","weight":1.0,"link_notes":"","source":{"id":"fa811221-13bd-5c10-adc1-eaf097c7703c","stable_key":"import-cb568d28-484a-5c2e-9fcc-2d780358e514","title":"Vitamin C: mechanisms, deficiency and nutrient interactions (2026-09-17)","document_type":"imported_text","citation_label":"AI-assisted literature curation; primary study URLs and scope retained in the document and extraction. Not publisher full text.","file_path":"","sha256":"b7fd83f956abb81855f2ea23199ba14e465cd91f4a2ac560277ec21ddafd7bfc","revision_id":"6cde9bbb-d712-5746-82a6-85b144253efa","review_status":"unverified_draft","notes":""}}],"relations":[],"conflicts":[],"corrections":[],"research":null}