Vitamin c boost: could a simple supplement make pancreatic cancer treatment safer?
NCT ID NCT01852890
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested whether adding high-dose vitamin C (ascorbate) to standard chemotherapy and radiation is safe for people with pancreatic cancer. Sixteen adults with pancreatic cancer took part. The main goal was to see how many serious side effects occurred, with a focus on whether the vitamin C caused any additional harm.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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16 people
The number who actually took part.
- Started
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Jan 2014
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have histologically or cytologically diagnosed pancreatic adenocarcinoma. Documentation of disease extent by CT scan is required. Radiologically measurable disease is not required. * Age ≥ 18 years * ECOG performance status 0, 1, or 2 (Karnofsky \> 50%). * A complete blood count and differential must be obtained within 21 days prior to radiation fraction 1, with adequate bone marrow functions as defined below: * Absolute neutrophil count (ANC) ≥ 1500 cells per mm3 * Platelets ≥ 100,000 per mm3 * Leukocytes ≥ 3,000 per mm3 * Serum blood chemistries within 21 days of radiation fraction 1, as defined below: * Creatinine ≤ 1.5 x UIHC upper limit of normal or creatinine clearance of at least 60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal. * Total bilirubin ≤ 2 x UIHC upper limit of normal * ALT ≤ 2.5 times the UIHC upper limit of normal * AST ≤ 2.5 times the UIHC upper limit of normal * PT/INR within normal limits (UIHC) * Tolerate one test dose (15g) of ascorbate. * Not pregnant. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * G6PD (glucose-6-phosphate dehydrogenase) deficiency. * Prior abdominal radiotherapy that would result in overlap of fields. The treating radiation oncologist should review prior RT fields as available. * Adjuvant therapy (including radiation therapy) within 2 calendar weeks. Toxicities from prior therapy for the malignancy should resolve to grade 1 or less. * Patients actively receiving insulin are excluded. * Patients who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide. High dose ascorbate may affect urine acidification and, as a result, may affect clearance rates of these drugs. * Second malignancy other than non-melanoma skin cancers within the past 5 years. * Other investigational agents/therapy with the intention to treat the disease under study (observational or imaging trials are acceptable). * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations, or any other condition that would limit compliance with study requirements as determined by study team members. * Pregnant or lactating women: The risks of radiation and chemotherapy to a fetus are well documented. * Known HIV-positive individuals. High-dose ascorbate acid is a known CYP450 3A4 inducer, which results in lower serum levels of antiretroviral drugs. A clinical trial designed to address these interaction issues is more appropriate than this phase 1 study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
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Other studies related to the condition(s) this trial covers.
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