Intravenous Vitamin C and Cancer: A Systematic Review
Abstract
Introduction
Methods
Search Strategy
Inclusion Criteria
Record Screening and Selection
Data Extraction
Results
High-Dose IVC
Randomized Controlled Trials
Phase I/II and Uncontrolled Studies
Reference | n | Population | Intervention | Concomitant Therapy | Outcomes | Adverse Events (AEs) |
---|---|---|---|---|---|---|
Randomized controlled trials | ||||||
Ma 2014 | 27 | Stage III-IV ovarian cancer who had undergone debulking sx | High-dose IVC 2×/wk × 6 mo with chemo, plus 6 mo postchemo; c/t chemo alone | Paclitaxel, carboplatin | ↓ Grade 1-II adverse events (P<0.05) ↑ Time to relapse and overall survival (NS trend) |
IVC patients reported 5-fold fewer adverse treatment effects (neurotoxicity, myelosupression, infection, hepatobiliary/ pancreatic toxicity, and toxicities of the renal, pulmonary, and gastrointestincal tract) |
Phase I/II studies | ||||||
Stephenson 2013; Stephenson 2007 | 17 | Variety of solid tumors including breast, colorectal, pancreatic, liver, lung, skin | Escalate to 50, 70, 90, and 110 g/m2 dose groups, 4 d/wk × 4 wk | None | No objective tumor response 13 PD, 3 SD, 1 withdrawal QOL stable for first 2 wk; ↑ at wk 3/4 Cmax 49 mM AUC no difference b/w 70/90/110 g/m2 dose groups (~220 mM) |
DLTs: grade 4 hypernatremia (n = 3) and grade 3 hypokalemia (n = 2) Mild-moderate AE: most commonly nausea or mild headache; 1-2 incidents each of hypertension, insomnia, abnormal urine color, decreased appetite, fatigue, chills, and hyperglycemia |
Welsh 2013 | 15 | Stage IV pancreatic adenocarcinoma; of 15 enrolled, 11 initiated IVC and 9 completed 1 cycle | Escalate to achieve plasma level ≥350 mg/dL (20 mM) 50-125 g given 2×/wk in 4 wk cycles until PD or toxicity |
Gemcitabine | Plasma vitamin C levels ranged from 20 to 25 mM at 1-h postinfusion ↑ Performance status (6/9 patients) Mean survival 13 ± 2 months Time to progression 26 ± 7 wk |
Dose limiting criteria not reached AE attributable to drug combination: dry mouth (n = 6) and diarrhea (n = 4) Grade 3 toxicities: elevated GGT (n = 2) and hypokalemia (n = 1), attributable to the disease process Other toxicities attributable to gemcitabine (ie, hematological) |
Monti 2012 | 14 | Stage IV pancreatic cancer | 3 dose groups: escalate to 50, 75, 100 g IVC 3 d/wk × 8 wk | Gemcitabine and erlotinib | Nine patients completed study: 7SD, 2 PD | No evidence of increased toxicity with addition of IVC. Transient mild nausea and light headedness d/t osmotic load during infusion |
Tumor mass ↓ 10% to 42% in 8 of 9 pt | Other AE attributable to chemo, most commonly grade 1-2 hematological (n = 12) | |||||
Mean progression-free survival 89 d; OS 182 d | ||||||
Plasma ascorbate in patients receiving 100 g was b/w 25.3 and 31.9 mM | ||||||
Hoffer 2008, Robitaille 2009 | 51 | Solid tumors or hematological malignancy | 3 doses/wk of 0.4, 0.6, 0.9, or 1.5 g/kg of ascorbic acid, for 2 weeks | No anticancer treatment 4 weeks prior to study | Physical function (FACT-G) ↓ in low-dose group (P < .01) but stable in the higher dose groups (≥0.6 g/kg) 1.5 g/kg dose maintained plasma vitamin C >10 mM for ~6 hours ↑ 6-hour urinary oxalate (81.3 mg/6 h; normal 10-60 mg), but not associated with AE No change in serum creatinine (eGFR) |
No differences in AE b/w dose levels: nausea, headache, abdominal cramps, diarrhea, flushing/perspiration (n = 1-2 for each AE, grade 1-2 for all) |
Mikirova 2007 | 11 | 9 cancer patients and 2 healthy volunteers | 15, 25, and 50 g single doses | None | Plasma antioxidant capacity (TRAP) pre and post IVC ↑ 2-4 fold | NR |
After 15 g, plasma vitamin C was between 3.4 and 5.1 mM | ||||||
Yeom 2007 | 39 | Stage IV cancer patients | 10 g IVC 2× in a 3-day interval + oral intake of 4 g daily × 1 wk | None | ↑ Global health score from 36 ± 18 to 55 ± 16 post-IVC (P = .001) | None reported |
↑ Functional scale (P < .05) | ||||||
↓ Symptom scales (fatigue, nausea/vomiting, pain, and appetite loss) (P < .005) | ||||||
Riordan 2005 | 24 | Most with colorectal primary tumors (19/24) and mets (22/24) | Continuous daily infusions of 150, 300, 430, 570, or 710 mg/kg, which is ~10, 30, 40, or 50g, ×8 weeks | None | Mean plasma ascorbate levels 1.1 ± 0.9 mM (range = 0.28-3.8 mM); not related to dose | Serious: 1 kidney stone, 1 incidence of reversible hypokalemia |
No significant change in RBCs, WBCs, neutrophils, lymphocytes, platelets, BUN, creatinine, hematocrit | Nonserious: nausea (n = 11), dry skin and mouth (n = 7), edema (n = 7), fatigue (n = 6) | |||||
Slight ↓ in uric acid during therapy |
Pharmacokinetics
Tumor response
Survival
Quality of life
DLTs and adverse events
Risk of bias
Observational Studies
Reference | n | Population | Intervention | Outcomes | AE |
---|---|---|---|---|---|
Prospective cohort | |||||
Takahashi 2012 | 60 | Newly diagnosed advanced cancer patients | Escalate to 50 g IVC, then adjusted to achieve 350-400 mg/dL serum ascorbic acid immediately postinfusion; Administered 2×/wk × 4wk | ↑ EORTC-QLQ-C30 global health score at 2 and 4wk c/t BL (S) ↓ Fatigue, pain, insomnia, constipation ↑ Physical, role, emotional, cognitive, and social functioning ↑ CGI in 60% of patients at 4 wk |
All AE mild (grade I), and no pt discontinued IVC d/t AE |
Retrospective cohort | |||||
Mikirova 2012 | 45 | Cancer of the prostate, breast, bladder, pancreatic, lung, thyroid, skin, Bcell lymphoma, many with mets | Escalate to 50 g 3×/wk, for median of 9 treatments (IQR = 5-18) | No objective tumor response↓ CRP while on IVC (76% patients) ↓ CRP correlated w ↓ PSA ↓ CEA, CA 27.29, CA 15.3 (NS) ↓ IL-2, TNF-α after 6 treatments (NS) Plasma vitamin C ~18 mM after 50 g infusions |
NR |
Subgroup (n = 11): cytokine analysis done after 6 treatments | |||||
Vollbracht 2011 | 125 | Stage IIa-IIb breast cancer: standard care N = 72; standard care + IVC N = 53 | 7.5 g IVC once per week × minimum of 4 wk | ↓ Symptoms of disease and chemo SE: nausea, loss of appetite, fatigue, depression, sleep disorders, dizziness, and hemorrhagic diathesis (S) | None reported |
Symptom intensity scores were almost 2-fold higher in the control group | |||||
Case–control study | |||||
Cameron & Pauling 1991 | 294+ 1532 | Terminal cancer patients treated with IVC + controls | 10-45 g IVC, most commonly 10 g, daily × 10 d, then 10 g/d oral indefinitely | Mean survival 343 days for vitamin C group vs 180 days for controls (1.9-fold increase) | NR |
Cameron & Pauling 1978 | 100+ 1000 | Terminal cancer patients treated with IVC + historic controls | 10-45 g IVC, most commonly 10 g, daily × 10 d, then 10 g/d oral indefinitely | Mean survival: 300+ days longer survival for vitamin C group c/t controls (5.6-fold increase) Survival times >1 y from the date of untreatability observed for 22 of 100 vitamin C–treated patients |
NR |
Cameron & Pauling 1976 | 100+ 1000 | Terminal cancer patients treated with IVC + historic controls | 10-45 g IVC, most commonly 10 g, daily × 10 d, then 10 g/d oral indefinitely | Mean survival: 210 days for vitamin C group compared to 50 days for controls (~4.2-fold increase) | NR |
Pharmacokinetics
Quality of life and side effects of chemotherapy
Tumor markers
Survival
Risk of bias
Case Reports
Reference | Cancer, Stage | Dose | Outcome |
---|---|---|---|
Padayatty 2006 | 3 patients with renal cell carcinoma with mets, bladder cancer, and stage III B-cell lymphoma | 15, 30, 65 g 2×/wk for first months, then variable (1-2×/wk or monthly) for several months | Unexpectedly long survival and objective tumor regression |
RCC with mets: declined conventional therapy: complete tumor regression with IVC at 1 y. Recurrence of second primary tumor at 6 y followed by death at 7 y | |||
Bladder cancer: local resection, declined chemo: health and without recurrence at 9 y | |||
Diffuse large B-cell lymphoma: local radiation only: complete regression of tumor at 1 y, no recurrence at 10 y | |||
Riordan 2004, Riordan 1998, Riordan 1996, Riordan 1990 | 7 patients with RCC (n = 2), CRC (n = 1), pancreatic (n = 1), non-Hodgkin’s lymphoma (n = 2), breast cancer (n = 1) | 30-100 g 2×/wk (1 pt 15 g); most patients maintained less frequent IVC treatment after achieving remission | All cases had objective remission and lived long-term cancer free; surpassed their life expectancy; or died after d/c’ing IVC |
RCC #1: lived cancer free ×14 y and died of CHF at 84 y | |||
RCC #2: objective remission (CXR) at 4 y | |||
CRC (advanced): clear of mets and primary at 1.5 y (CT scan) | |||
5-FU and leucovorin concurrently; no SE except when missed dose of IVC (N/D, ST pain, stomatitis) | |||
Pancreatic: “surpassed life expectancy”; IVC achieved SD and died on d/c’ing IVC d/t saying saw no change | |||
Non-Hodgkin’s lymphoma #1 (diffuse large B cell post sx for removal of 2 mets LN): remains cancer free at 2 y | |||
Non-Hodgkin’s lymphoma #2 (recurrent after initial chemo): CT scan clear, “complete remission” per oncologist at 11 mo | |||
Breast cancer (w bone mets): 100 g × 5 d in hospital; d/c’d morphine, bone scan showed resolution of some skull mets at 3 mo | |||
Drisko 2003 | 2 patients with stage IIIC ovarian adenocarcinoma; IVC alongside cytoreduction with sx, standard paclitaxel/carboplatin × 6 cycles | 60 g 2×/wk; after cancer cleared, maintained at 3-4×/y | Case #1: Postchemo was negative for measurable disease (CT scan). Began IVC after first round of chemo; was disease free at 40 months and normal CA-125 |
Case #2: After initial sx and first round of chemo, disease found in pelvis (8 cm mass with local mets); declined further chemo, started IVC; patient well 3 y postdiagnosis, CA-125 normal, and physical exam normal | |||
Jackson 2002 | 153 cases seen over 16 years of practice | 15-115 g per dose; total 104, 432 g given over 16 y | Safety: No significant AE and no sign of serious kidney disease |
De Oliveira 1998 | 1 patient with melanoma and mets to lung; Sx to remove primary tumor | 50 g IVC 5 d/wk × 1 mo, then less frequently × 1 y. Oral nutritional supplements also given | At both 5 mo and 1 y, CT and X-ray showed that the lung was free of mets |
Jackson 1995 | 1 patient with pancreatic cancer, blocked bile duct, and mets to regional LN. Sx only for removal of primary | 57.5-115 g 3×/wk × 13wk | At 6 mo, abdominal CT scan showed no progression of tumor. Recurrence occurred when IVC treatments reduced to allow patient to travel. No chemo/radiation was given and pt had good QOL until death. Survival was 1 y from initial diagnosis |
Campbell 1979 | 2 patients with advanced Hodgkin’s disease (with dyspnea at rest and/or pleural effusion), and 1 case of bronchial carcinoma (with dyspnea and atelectasis of the left lower lobe) | 30 g IVC over 36 h | Case 1 developed symptoms of acute fever and pain in the tumor mass; symptoms resolved 2 d after d/c’ing IVC. Upon resolution over the next 48 h, low-dose IVC was gradually resumed, starting at 4 g/d and escalated to 10 g/d, and was well tolerated |
20 g IVC/d ×10 d | Case 2 developed acute SOB and symptoms of mediastinal compression; he was given emergency chemo which resulted in rapid symptom improvement. IVC was not reinstituted | ||
100 g IVC over 7 d | Case 3 developed SOB and acute mediastinal compression; he was treated with chemo that resulted in rapid improvement, followed by radiation therapy. IVC was not reinstituted | ||
Campbell 1975, 1980, 1991 | 1 patient with histologically proven, disseminated reticulum cell sarcoma (lymphoma) | HD-IVC, dose NR | “Dramatic regression of . . . disease activity was induced by the continuous administration of large doses of ascorbic acid” with radiological documentation |
In 1980, occurrence of a papillary thyroid carcinoma is reported | |||
In 1991, patient is reported to be alive 17 years later | |||
Cameron 1974 | 50 terminally ill cancer patients not responding to conventional therapy and >4 months since surgery or chemotherapy: lung (7), renal (4), bladder (6), brain (1), colorectal (9), gallbladder (2), stomach (5), breast (7), ovary (3), pancreatic (1), other (3) | 5-45 g/d ascorbic acid for12-10 days (IV) + 10 g oral vitamin C daily | 1 year survival: 16% (8 patients) Tumor response (n): no response 17; minimal response 10; growth retardation 11; cytostasis 3; tumor regression 5; tumor hemorrhage or necrosis 4 Objective benefit: ↓ pain and need for pain meds in bone mets; ↓ ascites and pleural effusion; ↓ hematuria; ↓ hepatomegaly and jaundice; ↓ elevated ESR |
Low-Dose IVC
Reference | n | Population | Intervention | Concomitant Therapy | Outcomes | Adverse Events |
---|---|---|---|---|---|---|
Randomized controlled trials | ||||||
Dammacco 1992 | 51 | MM not receiving other therapy and no prior chemo | 1 g IV vitamin C ×7 d c/t cefodizime 2 g IV ×7 d | None | No change in neutrophil chemiluminescence or phagocytosis, or granulocyte chemotaxis in IVC group | NR |
Phase I/II trials | ||||||
Welch 2010 [conference abstract] | 13 | Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) | 1 g IVC following each administration of arsenic trioxide ×15 wk (d 1-5, then weekly) | Arsenic trioxide (dose escalated) and decitabine | Median OS was 207 d, and 4 patients remain alive with median f/u of 490 d | Toxicities attributable to chemotherapy |
DLT pneumonia/infection | ||||||
Grade 3-4 toxicities were infection, hypotension, hypoxia/pneumonia, anemia, neutropenia, QTc prolongation, pericardial and pleural effusion, hyperglycemia, hypokalemia | ||||||
Berenson 2007 | 22 | MM (relapsed or unresponsive to standard therapy) | 1 g IVC on days 1, 4, 7, and 11 of a 21-d chemo cycle for max of 8 cycles | Arsenic trioxide and bortezomib | 0 CR, PR 2, minor response 4, SD 9 | Attributable to chemotherapy: grade 1-2: pneumonia, chest pain, abdominal pain, back pain, increased QT, asymptomatic arrhythmia, cardiomyopathy, bacteremia, bortezomib intolerance, hyperkalemia, severe decrease in quality of life |
Median PFS 5 mo (95% CI 2-9) | Grade 4 thrombocytopenia (n = 1) | |||||
12-month PFS 34% (13-55); 12-month OS 74% | ||||||
Berenson 2006 | 65 | MM (relapsed or unresponsive to standard therapy) | 1 g IVC on days 1-4 of wk 1, 2×/wk of wk 2-5; 6 wk cycle | Melphalan and arsenic trioxide | Objective response in 31 of 65 patients (48%): 2 CR, 15 PR, 14 minor responses | Grade 3-4 toxicities attributable to chemo: hematological, cardiac, fever/chills, pain, and fatigue |
Median PFS 7 mo; OS 19 mo | ||||||
↓ Elevated serum creatinine | ||||||
Abou-Jawde 2006 | 20 | MM (relapsed or unresponsive to standard therapy) | 1 g IVC on days of arsenic trioxide; 14-15 wk cycles | Arsenic trioxide and dexamethasone | 30% response rate, with at least stable disease in 80% of patients. Median PFS 316 d in all patients and 584 d in those with a response | Well tolerated, with most adverse events being mild or moderate |
Wu 2006 | 20 | MM (relapsed or unresponsive to standard therapy) | 1 g IVC on days 1-4 of wk 1, 2×/wk of wk 2-5; minimum 4 cycles | Arsenic trioxide and dexamethasone | PR 2, minor response 6 | Common AE: grade 1-2 bacterial infections (n = 10), peripheral edema (n = 8), fatigue (n = 7), dyspnea (n = 6), reactivation of herpes zoster (n = 5), neuropathy (n = 5), neutropenia (n = 4), thrombocytopenia (n = 3), and malaise (n = 3) |
At the time of follow-up (median follow-up 9 mo), 11 patients were alive | Grade 3- 4 AE: bacterial infections (n = 6), neutropenia (n = 3), hepatic toxicity (n = 3), and thrombocytopenia (n = 2) | |||||
Borad 2005 | 10 | Refractory MM | 1 g IVC following each dose of arsenic trioxide (2×/wk) | Melphalan and arsenic trioxide | All 10 patients responded to therapy | Generally well tolerated, with minor treatment delays d/t QT interval prolongation, thrombocytopenia, and neutropenia |
↓ Serum M-protein levels by 29% to 90% ↓ Urine M-protein b/w 34% and 71% |
Most common AE: fatigue (n = 7), bone marrow suppression (n = 4), leukopenia (n = 7), thrombocytopenia (n = 4), QT prolongation (n = 5), neuropathy (n = 4), gastrointestinal symptoms (n = 4), pulmonary and peripheral edema (n = 2), herpes zoster reactivation (n = 2), headache (n = 2), skin rash (n = 3) | |||||
Bahlis 2002 | 6 | Stage IIIA relapsed/refractory myeloma | 1 g IVC on each day of arsenic trioxide (25 d over 35 d period) | Arsenic trioxide | PR 2; SD 4Arsenic trioxide + 1 g/d IVC could be given for 25 days w/o DLT Co-administration of IVC did not alter arsenic PK, and ↑ vitamin C levels associated w ↓ GSH |
Grade 3 hematological toxicity (leukopenia, n = 1) |
Randomized Controlled Trials
Phase I/II and uncontrolled studies
Interactions
Discussion
Survival Time in Phase I/II Studies
Symptom Management and Quality of Life
Mechanism of Action
Safety
Interactions
Limitations
Strengths
Acknowledgments
Declaration of Conflicting Interests
Funding
Appendix
Search Strategies (Updated in April 2013)
1 | (intravenous vitamin c or IV vitamin c).tw. |
2 | exp Ascorbic Acid/ |
3 | Injections, Intravenous/ |
4 | 2 and 3 |
5 | ((vitamin c or ascorbic acid or l-ascorbic acid or sodium ascorbate or magnesium ascorbicum or magnorbin or ferrous ascorbate or hybrin) adj3 (intravenous$ or intra-venous$ or IV)).tw. |
6 | 1 or 4 or 5 |
7 | human/ |
8 | 6 and 7 |
Database: EMBASE, Ovid MEDLINE(R)
The Cochrane Library
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