Can High-Dose vitamin c boost Chemo's punch against pancreatic cancer?
NCT ID NCT03410030
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This trial is testing whether adding high-dose vitamin C (ascorbic acid) to a standard three-drug chemotherapy cocktail can safely and effectively control metastatic pancreatic cancer in people who have not yet received any treatment. The study enrolls adults with stage IV pancreatic cancer and aims to find the best dose of vitamin C that can be given alongside the chemo. Researchers are watching for tumor shrinkage and how long the disease stays stable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- high-dose vitamin C (ascorbic acid) plus a combination of chemotherapy drugs: nab-paclitaxel, cisplatin, and gemcitabine
- What this could lead to
- If it works, this could point toward a more effective first-line treatment for metastatic pancreatic cancer, a disease with very few good options.
- What could go wrong
- This is an early-phase trial with only 17 participants, so results may not apply broadly. High-dose vitamin C can cause kidney stones and other side effects, and the chemo combination itself is intense.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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17 people
The number who actually took part.
- Started
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Dec 2017
- Finished
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Sep 2023
- 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 meet the following criteria to be included in the trial: * Be willing and able to provide written informed consent/assent for the trial. * Be ≥ 18 years of age on day of signing informed consent. * Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (with measurable disease according to RECIST 1.1 criteria). * Have a performance status of 0 or 1 on the ECOG performance scale. * Demonstrate adequate organ function as defined below in table 4. All screening labs should be performed within 14 days of treatment initiation. * Female participants of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving first dose of study medication. * Female participants of childbearing potential must be willing to use adequate method of contraception (as outlined in section 4.4.2) for the duration of the trial. * Male participants must agree to use adequate contraception (as outlined in section 4.4.2) for the duration of the trial. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant. Exclusion Criteria: Patients must not meet any of the following criteria in order to be eligible for the trial: * Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the adjuvant setting with gemcitabine and/or 5-FU or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. * Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment. * Exposure to any investigational agent within 4 weeks prior to initiation of study treatment. * Patients who need constant use of finger stick blood glucose monitoring for tight contro l of their diabetes being the ascorbic acid causes false low readings of glucose via that technology (Vasudevan and Hirsch 2014) 39 * Any person with a G6PD deficiency * History of renal oxalate stones (if type of stone is unknown, need to assess urine oxalates level if \>60mg/dL, then patient is not eligible for the study) * Patient is taking acetaminophen at any dose, or any medication that contains acetaminophen within 72 hours of first dose of ascorbic acid. * Hypersensitivity to any of the agents proposed for treatment. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. * Has an active infection requiring systemic therapy. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through one week from the last dose of trial treatment. * Patients with evidence of iron overload, defined as a transferrin saturation \> 45 percent AND serum ferritin \> 200 ng/mL (males) or \>150 ng/mL (females). * Current, serious, clinically significant cardiac arrhythmias as determined by the investigator, or patient receiving a digitalis derivative.
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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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HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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