Adding high-dose vitamin C to chemotherapy and radiation for lung cancer
A Phase 2 Trial of Pharmacological Ascorbate With Concurrent Chemotherapy and Radiation Therapy for Non-small Cell Lung Cancer
This study is testing if adding high-dose vitamin C to standard chemotherapy and radiation can help people with non-small cell lung cancer feel better during their treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT02905591 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the addition of high-dose ascorbate (vitamin C) to the standard treatment regimen of radiation therapy combined with carboplatin and paclitaxel for patients with non-small cell lung cancer (NSCLC). Participants will receive 75 grams of intravenous ascorbate three times a week during their radiation therapy sessions. The study aims to assess the biological effects of ascorbate on the body while undergoing standard cancer treatment. Imaging and blood samples will be collected to monitor the effects of the therapy over a period of 10 to 12 weeks, followed by standard follow-up care.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with non-small cell lung cancer who are recommended to receive carboplatin and paclitaxel with radiation therapy.
Not a fit: Patients with recurrent non-small cell lung cancer or those with significant pleural effusion may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of standard therapies for non-small cell lung cancer, potentially improving patient outcomes.
How similar studies have performed: While the use of high-dose ascorbate in cancer treatment is being explored, this specific combination with standard therapies for NSCLC is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Note: patients who have a small pleural effusion that is too small to safety tap and is not visible on a chest x-ray are still eligible * Pathologic diagnosis (i.e., cell sample, biopsy, tissue swap, bronchoscopy) of non-small cell lung cancer. * Recommended to receive carboplatin \& paclitaxel with radiation therapy as a treatment * Tumor or metastatic disease must measure at least 1 cm using a CT scan (CAT scan) * Physician determined the patient is healthy enough for chemotherapy and radiation therapy * At least part of the lung cancer must be viewable and measurable by CT or MRI * A platelet count of at least 100,000 cells per mililiter * A creatinine level of less than 1 1/2 times the upper limit of normal for the local lab test, or, a creatinine clearance of at least 60 mL/(min\*1.73m2) * Not pregnant, and commit to using birth control during the study Exclusion Criteria: * Exudative pleural effusion * Recurrent non-small cell lung cancer * Glucose-6-phosphate dehydrogenase (G6PD) deficiency * Patients actively receiving insulin or patients whose doctors have recommended current insulin use * Patients requiring daily finger-stick blood glucose measurements * Patients who are on the following drugs and cannot have a substitution or who decline the substitution: * warfarin * flecainide * methadone * amphetamines * quinidine * chlorpropamide * Prior radiation therapy that would result in a field overlap * Enrolled in another therapeutic clinical trial * Uncontrolled, intercurrent illness * Lactating women * HIV positive individuals undergoing therapy due to known drug:drug interaction between antiretroviral drugs and high-dose ascorbate therapy If all the above are met, the potential participant will receive a 15 gram challenge dose of ascorbate via intravenous infusion. This is the final screening procedure.
Where this trial is running
Iowa City, Iowa
- Holden Comprehensive Cancer Cener — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Study coordinator: Bryan G Allen, MD, PhD
- Email: bryan-allen@uiowa.edu
- Phone: 319-353-8836
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.