Vitamin E for prevention of oxaliplatin-induced peripheral neuropathy: a pilot randomized clinical trial

Afonseca, Samuel Oliveira de; Cruz, Felipe Melo; Cubero, Daniel de Iracema Gomes; Lera, Andrea Thaumaturgo; Schindler, Fernanda; Okawara, M.; Souza, Luiz Carlos Bento de; Rodrigues, Nataly Pimentel; Giglio, Auro del

doi:10.1590/s1516-31802013000100006

Cited by 43 publications

(39 citation statements)

References 11 publications

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“…In fact, daily infusions of an investigational prophylactic CIPN treatment throughout the full course of chemotherapy are not likely to be feasible. On the contrary, oral or topical medications that target the nervous system – such as anti-epileptics, anti-depressants, or anti-inflammatory agents that are being used to decrease pain or augment pain inhibition – would likely best be initiated before the start of chemotherapy and continued until the end of chemotherapy (e.g., [1,75,92]) or for 2 weeks to 3 months after chemotherapy completion (e.g., [8,9,63,128,129]).…”

Section: Design Considerations In the Context Of 4 Illustrative Prmentioning

confidence: 99%

Research design considerations for chronic pain prevention clinical trials

Gewandter

Dworkin

Turk

et al. 2015

Pain

130

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Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (i.e., chronic post-surgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (i.e., surgery, viral infection, injury, and toxic/noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.

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Section: Design Considerations In the Context Of 4 Illustrative Prmentioning

confidence: 99%

Research design considerations for chronic pain prevention clinical trials

Gewandter

Dworkin

Turk

et al. 2015

Pain

130

View full text Add to dashboard Cite

show abstract

“…Numerous studies have examined the role of vitamin E in reducing the risk of CIPN occurrence; however, some aspects of this relation still remain controversial. Pace et al Afonseca et al have reported no significant effect for vitamin E on the occurrence of oxaliplatin-induced neuropathy (8). Thus, more research should be conducted to explain how vitamin E could act as a neuroprotective agent in this context.…”

Section: Introductionmentioning

confidence: 98%

The Vitamin E Preventive Effect on Taxol-Induced Neuropathy Among Patients With Breast Cancer: A Randomized Clinical Trial

Shamsaei

Ahmadzadeh

Mehraban

2017

Jundishapur J Nat Pharm Prod

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Background: Chemotherapy-induced neuropathy is one of the most severe complications of cancer drug therapies causing a number of problems for patients and making treatment limitation decisions problematic. One of the most important drugs used in breast cancer chemotherapy regimens, Taxol is considered as the most common cause of neuropathy in such cases. The aim of this study was to evaluate the effect of vitamin E on reducing the Taxol-induced neuropathy development among patients with breast cancer. Methods: The randomized clinical trial (RCT) included 70 patients with breast cancer who received Taxol chemotherapy regimens. They were assigned to one of the two groups: a group without vitamin E feeding (Group I) and a group with vitamin E treatment at a daily dose of 400 IU bid (Group II). Electrophysiological testing of all patients was performed before starting medications and again 3 months post-treatment. The data were compared between the groups. Results: Vitamin E feeding had no significant effect on amplitude, latency, and CV of tibial and peroneal nerves (P > 0.05), while the delta amplitude of sural nerve was significantly lower among patients taking vitamin E supplements (P = 0.007). Conclusion:We suggest the inhibitory effect of vitamin E on the progression of Taxol-induced neuropathy, by slowing the speed of progression, among breast cancer patients by improving the function of the nervous system.

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“…The bulk of evidence is negative for both scenarios [12], [14], [19], [20], with rare exceptions [17], [21]. Importantly, the large majority of studies have not used validated pain measurement tools [10], [11], [13], [14], [16], [19], [22], [23], while most have used the common terminology criteria (CTC) adverse events grading system as the primary outcome measurement. While this choice is sound and supported by robust evidence [24], it must be kept in mind that most patients with OXAIPN have small‐fiber‐predominant polyneuropathy [1], which has as its main symptom neuropathic pain.…”

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confidence: 99%

Pregabalin for the Prevention of Oxaliplatin-Induced Painful Neuropathy: A Randomized, Double-Blind Trial

et al. 2017

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Lessons Learned. Pregabalin is a medication that can decrease neuronal hyperexcitability, relieve neuropathic pain, and reach stable plasma levels after a titration period of only a few days.Its use during oxaliplatin infusions was not able to decrease the incidence of chronic, oxalipaltin‐related neuropathic pain, compared with placebo.Background.Patients with colorectal cancer (CRC) receiving oxaliplatin (OXA) develop acute and chronic painful oxaliplatin‐induced peripheral neuropathy (OXAIPN). Acute and chronic OXA‐related neuropathies have different pathophysiological bases, but both lead to a common phenomenon: central sensitization (CS) of nociceptive neuronal networks, leading to increased sensitivity (hyperlgesia, allodynia) in the somatosensory system, the common ground of chronic neuropathic pain. Because CS is related to increased risk of painful OXAIPN, we hypothesized that preemptive use of the anti‐hyperalgesic drug pregabaline (known to decrease CS) during OXA infusions would decrease the incidence of chronic OXAIPN.Methods.Pain‐free, chemotherapy‐naïve CRC patients receiving at least one cycle of modified‐FLOX [5‐FU(500 mg/m2)+leucovorin(20 mg/m2)/week for] 6 weeks+oxaliplatin(85 mg/m2) at weeks 1‐3‐5 every 8 weeks] were randomized (1:1) into the study. Patients received either pregabalin or placebo for 3 days before and 3 days after each OXA infusion and were followed for up to 6 months. Clinical assessments were performed at baseline, at the end of chemotherapy, and after the follow‐up period. The main outcome was average pain at the last visit assessed by the visual analogic scale (0–10) item of the Brief Pain Inventory (BPI). Secondary endpoints were presence of neuropathic pain according to the Douleur Neuropathique‐4 (DN‐4), pain dimensions (short‐ form McGill Pain Questionnaire [MPQ]), Neuropathic Pain Symptom Inventory (NPSI), and changes in nerve conduction studies (NCS) and side effect profile.Results.One hundred ninety‐nine patients (57.0 ± 10.7 years old, 98 female, 101 male) were randomized. Data from 56 patients were not included in the analyses (as they did not receive at least one full cycle of modified FLOX). Data from 78 patients in the pregabalin group and 65 patients in the placebo group were retained for analyses. At the last visit, pain intensity in the pregabalin group was 1.03 (95% confidence interval [CI] = 0.79–1.26), and 0.85 (95% CI = 0.64–1.06) in the placebo group, which did not reach significance. Scores from the BPI, MPQ, DN‐4, NPSI, and NCS and side‐effect profiles and incidence of death did not differ between groups. Quality of life (QoL) score did not differ between groups (placebo = 76.9 ± 23.1, pregabalin group 79.4 ± 20.6). Mood scores were not significantly different between groups (placebo 9.7 [8.1–11.2]; pregabalin 6.8 [5.6–8.0]).Conclusion.The preemptive use of pregabalin during OXA infusions was safe, but did not decrease the incidence of chronic pain related to OXAIPN.

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Vitamin E for prevention of oxaliplatin-induced peripheral neuropathy: a pilot randomized clinical trial

Cited by 43 publications

References 11 publications

Research design considerations for chronic pain prevention clinical trials

Research design considerations for chronic pain prevention clinical trials

The Vitamin E Preventive Effect on Taxol-Induced Neuropathy Among Patients With Breast Cancer: A Randomized Clinical Trial

Pregabalin for the Prevention of Oxaliplatin-Induced Painful Neuropathy: A Randomized, Double-Blind Trial

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