Role of calcium and magnesium infusion in prevention of oxaliplatin neurotoxicity. A phase III trial

Gobran, Nagy Samy

doi:10.1007/s10330-013-1161-7

Cited by 7 publications

(11 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A study published in 2013 in the Chinese-German Journal of Clinical Oncology has also supported findings of a statistically significant reduction in neurotoxicity in patients receiving calcium and magnesium with oxaliplatin infusions (Gobran, 2013). The study was conducted from July 2008 through February 2011 and enrolled 30 patients to the calcium/ magnesium treatment arm and 30 patients to the placebo arm.…”

Section: Prospective Randomized Controlled Trialsmentioning

confidence: 78%

The Use of Calcium and Magnesium to Prevent Neurotoxicity in Patients Receiving Oxaliplatin

Martyn¹,

Petito²

2015

JADPRO

View full text Add to dashboard Cite

show abstract

Section: Prospective Randomized Controlled Trialsmentioning

confidence: 78%

The Use of Calcium and Magnesium to Prevent Neurotoxicity in Patients Receiving Oxaliplatin

Martyn¹,

Petito²

2015

JADPRO

View full text Add to dashboard Cite

show abstract

“…Specifically, only one prevention study utilized both clinical assessment and a patient-reported outcome (PRO) measure with strong psychometric properties. [29] Three studies[181920] used either a CIPN clinical examination or PRO with adequate validity and reliability. Physician-graded (the NCI-CTCAE or WHO) scales were the primary CIPN measure in nine studies.…”

Section: Resultsmentioning

confidence: 99%

“…Physician-graded (the NCI-CTCAE or WHO) scales were the primary CIPN measure in nine studies. [161718222324273041] Eligibility criteria were not reported in four studies,[16222529] and various studies lacked control for peripheral neuropathy-associated comorbidities, chemotherapy regimen and dose received,[1724272830] previous receipt of chemotherapy,[17192930] and concomitant analgesics/psychotropics/neuroleptics. [161719222324252729] Finally, several studies may have utilized an inadequate drug dosage[2230] or a drug that mechanistically would possibly not lead to meaningful benefits in the outcome.…”

Section: Resultsmentioning

confidence: 99%

Characterization of Internal Validity Threats to Phase III Clinical Trials for Chemotherapy-Induced Peripheral Neuropathy Management: A Systematic Review

Lee

Kanzawa-Lee

Knoerl

et al. 2019

Asia-Pacific Journal of Oncology Nursing

View full text Add to dashboard Cite

Objective: The recent American Society of Clinical Oncology (ASCO) Clinical Guidelines for chemotherapy-induced peripheral neuropathy (CIPN) management (48 Phase III trials reviewed) only recommend duloxetine. However, before concluding that a CIPN intervention is ineffective, scientists and clinicians should consider the risk of Type II error in Phase III studies. The purpose of this systematic review was to characterize internal threats to validity in Phase III CIPN management trials. Methods: The PubMed, CINAHL, EMBASE ® , and Scopus databases were searched for Phase III clinical trials testing interventions for CIPN management between 1990 and 2018. The key search terms were neoplasms, cancer, neuropathy, and CIPN. Two independent researchers evaluated 24 studies, using a modified Joanna Briggs Institute Checklist for Randomized Control Trials developed by the authors specific for CIPN intervention trials. Results: Two studies exhibited minimal or no design flaws. 22/24 Phase III clinical trials for CIPN have two or greater design flaws due to sample heterogeneity, malapropos mechanism of action, malapropos intervention dose, malapropos timing of the outcome measurement, confounding variables, lack of a valid and reliable measurement, and suboptimal statistical validity. Conclusions: Numerous CIPN interventions have been declared ineffective based on the results of Phase III trials. However, internal validity threats to numerous studies may have resulted in Type II error and subsequent dismissal of a potentially effective intervention. Patients may benefit from rigorous retesting of several agents (e.g., alpha-lipoic acid, duloxetine, gabapentin, glutathione, goshajinkigan, lamotrigine, nortriptyline, venlafaxine, and Vitamin E) to expand and validate the evidence regarding ASCO's recommendations for CIPN management.

show abstract

“…Although these medications have been proven to be effective in preventing CIPN, their therapeutic potential is limited due to contradictive conclusions and unexpected side effects ( Wolf et al, 2008 ; Ceresa and Cavaletti, 2011 ). For example, Ca/Mg decreased neuropathy by about 50% compared with a historical control group ( Gobran, 2013 ). However, Ca/Mg can interfere with the response to oxaliplatin-based chemotherapy, and is shown to be ineffective in a large phase III clinical trial ( Gamelin et al, 2008 ; Loprinzi et al, 2014 ).…”

Section: Treatment Options For Cipn and Limitationsmentioning

confidence: 94%

“…So far a variety of pharmacological strategies have been tested to improve the neurological symptoms of CIPN. These promising drugs include PARP inhibitors, Ca/Mg, vitamin E, amifostine, glutathione, glutamine, N -acetylcysteine, acetyl- L -carnitine, recombinant human leukemia inhibitory factor, and venlafaxine ( Flatters et al, 2006 ; Cavaletti, 2011 ; Gobran, 2013 ; Ta et al, 2013 ). Although these medications have been proven to be effective in preventing CIPN, their therapeutic potential is limited due to contradictive conclusions and unexpected side effects ( Wolf et al, 2008 ; Ceresa and Cavaletti, 2011 ).…”

Section: Treatment Options For Cipn and Limitationsmentioning

confidence: 99%

Chemotherapy-induced peripheral neurotoxicity and complementary and alternative medicines: progress and perspective

Cheng

Liu

Wang³

et al. 2015

Front. Pharmacol.

View full text Add to dashboard Cite

Chemotherapy-induced peripheral neurotoxicity (CIPN) is a severe and dose-limiting side effect of antineoplastic drugs. It can cause sensory, motor and autonomic system dysfunction, and ultimately force patients to discontinue chemotherapy. Until now, little is understood about CIPN and no consistent caring standard is available. Since CIPN is a multifactorial disease, the clinical efficacy of single pharmacological drugs is disappointing, prompting patients to seek alternative treatment options. Complementary and alternative medicines (CAMs), especially herbal medicines, are well known for their multifaceted implications and widely used in human health care. Up to date, several phytochemicals, plant extractions, and herbal formulas have been evaluated for their potential therapeutic benefit of preventing the onset and progression of CIPN in experimental models. Clinical acupuncture has also been shown to improve CIPN symptoms. In this review, we will give an outline of our current knowledge regrading the advanced research of CIPN, the role of CAMs in alleviating CIPN and possible lacunae in research that needs to be addressed.

show abstract

Role of calcium and magnesium infusion in prevention of oxaliplatin neurotoxicity. A phase III trial

Cited by 7 publications

References 16 publications

The Use of Calcium and Magnesium to Prevent Neurotoxicity in Patients Receiving Oxaliplatin

The Use of Calcium and Magnesium to Prevent Neurotoxicity in Patients Receiving Oxaliplatin

Characterization of Internal Validity Threats to Phase III Clinical Trials for Chemotherapy-Induced Peripheral Neuropathy Management: A Systematic Review

Chemotherapy-induced peripheral neurotoxicity and complementary and alternative medicines: progress and perspective

Contact Info

Product

Resources

About