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

2013 ◽  
Vol 131 (1) ◽  
pp. 35-38 ◽  
Author(s):  
Samuel Oliveira de Afonseca ◽  
Felipe Melo Cruz ◽  
Daniel de Iracema Gomes Cubero ◽  
Andrea Thaumaturgo Lera ◽  
Fernanda Schindler ◽  
...  
Keyword(s):  
Placebo Group ◽  
Vitamin E ◽  
Peripheral Neuropathy ◽  
Group Versus ◽  
University Hospital ◽  
Magnesium Supplementation ◽  
Oxaliplatin Treatment ◽  
Before And After ◽  
The Common ◽  
To Receive

CONTEXT AND OBJECTIVEOxaliplatin is one of the chemotherapy regimens most used for treating colorectal cancer. One of the main limitations to its use is induction of peripheral neuropathy. Previous studies have shown that vitamin E can reduce the incidence of peripheral neuropathy by 50%. This study aimed to assess the effectiveness of vitamin E for prevention of oxaliplatin-induced peripheral neuropathy.DESIGN AND SETTINGProspective, phase II, randomized pilot study developed at a university hospital in the Greater ABC region.METHODSPatients were randomized five days before starting oxaliplatin treatment, to receive either vitamin E or placebo until the end of the chemotherapy regimen. The outcome was evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), version 3, and specific gradation scales for oxaliplatin-induced peripheral neuropathy. Patients with colorectal and gastric cancer who had been scheduled to receive oxaliplatin-based chemotherapy were included. Both groups received calcium and magnesium supplementation before and after oxaliplatin infusions.RESULTSEighteen patients were randomized to the vitamin E group and 16 to the placebo group. Cumulative incidence of 83% with peripheral neuropathy grades 1/2 was observed in the vitamin E group, versus 68% in the placebo group (P = 0.45). A trend towards more diarrhea was observed among patients who received vitamin E (55.6% vs. 18.8%; P = 0.06). There were no other significant differences in toxicity between the groups.CONCLUSIONSNo significant decrease in the incidence of acute oxaliplatin-induced peripheral neuropathy was demonstrated through vitamin E use.CLINICAL TRIAL REGISTRATIONNCT01523574.

Vitamin E in the neuroprotection of cisplatin induced peripheral neurotoxicity and ototoxicity

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9114-9114 ◽  
Author(s):  
A. Pace ◽  
S. Carpano ◽  
E. Galiè ◽  
A. Savarese ◽  
M. Della Giulia ◽  
...  
Keyword(s):  
Placebo Group ◽  
Vitamin E ◽  
Peripheral Neurotoxicity ◽  
Double Blind ◽  
Multicentric Study ◽  
Phase Ii Studies ◽  
Significant Difference ◽  
Before And After ◽  
Vitamin E Supplementation

9114 Background: Peripheral neurotoxicity is a well recognized effect of cisplatin chemotherapy that can result in severe disability and represents a major dose-limiting factor. Several phase II studies have recently investigated the role of vitamin E as neuroprotectant in the prevention of cisplatin induced peripheral neurotoxicity and ototoxicity. Methods: An Italian randomized, placebo controlled, double blind multicentric study is ongoing to confirm the role of vitamin E supplementation in the prevention of neurotoxicity and ototoxicity induced by cisplatin Patients candidates to cisplatin chemotherapy were randomised to either vitamin E supplementation (a-tocopherol 400 mg/day) or to placebo. Patients were evaluated with neurological and neurophysiological examination before and after treatment. Neurotoxicity was measured using the comprehensive clinical and neurophysiological Total Neuropathy Score (TNS). Ototoxicity was evaluated with audiometric test and acoustic evoked potential before and after treatment. Results: 81 patients have been enrolled in 3 italian oncologic centers. An interim analysis on the first 50 patients was carried out. 25 patients (11 in the vit E group and 14 in the placebo group) received a cumulative dose higher than 300 mg/mq and were evaluable for neurotoxicity. Statistical analysis showed a significant difference (p < 0.05) in median neurotoxicity score observed in vit E group (TNS=1) respect to the placebo group (TNS=5). Conclusions: This is the first randomised, placebo controlled, double blind trial exploring the efficacy of vitamin E in the neuroprotection of cisplatin neurotoxicity. The results of this study confirm the neuroprotective effect of vitamin E supplementation against cisplatin-induced neurotoxicity. No significant financial relationships to disclose.

scholarly journals Hypofractionated Radiotherapy Using Simultaneous Integrated Boost Technique with Concurrent and Adjuvant Temozolomide for Glioblastoma

2020 ◽  
pp. 16-23
Author(s):  
Manal M. S. Elghareeb ◽  
Hanan Ahmed Wahba ◽  
Ahmed M. El- Demeri ◽  
Mohamed Elashry ◽  
Rasha Abd El Ghany Khedr
Keyword(s):  
Performance Status ◽  
Group Versus ◽  
Target Volume ◽  
Simultaneous Integrated Boost ◽  
University Hospital ◽  
Hypofractionated Radiotherapy ◽  
Conventional Radiotherapy ◽  
Integrated Boost ◽  
A Prospective Study ◽  
To Receive

Aim: This study was conducted to assess the safety and efficacy of postoperative hypofractionated radiotherapy (HRT) using simultaneous integrated boost (SIB) technique for glioblastoma (GBM) compared to conventional radiotherapy (CRT). Study Design: This was a prospective study with historical control arm. Place and Duration of the Study: Department of Clinical Oncology and Nuclear Medicine, Mansoura University Hospital, Mansoura, Egypt, between May 2017 and June 2019. Methods: The intervention (HRT) group included 30 patients who received 3D conformal HRT with SIB using field in field (FIF) technique to deliver a differential radiation dose to different targets. Planning target volume 60 (PTV60) includes the gross target volume (GTV) plus a 5-mm margin, and PTV45 includes the GTV plus a 15-mm margin. PTV60 will receive 60 Gy in 20 fractions, and PTV45 will receive 45 Gy in the same 20 fractions (one fraction daily and 5 days per week).The CRT group included 30 patients who received 3D conformal CRT with total dose 60 Gy in 2-Gy fractions delivered over 6 weeks. Both groups was planned to receive concurrent and adjuvant temozolamide. Results: The median PFS was 10 months in both groups. The median OS was 13 months in HRT group versus 12 months in CRT group which is statistically non significant. The toxicities were mild and acceptable. Performance status and adjuvant temozolamide were significant predictors that affect the overall survival. Conclusions: HRT with SIB using 3D conformal RTH with (FIF) technique in patients with GBM is a feasible and safe treatment and its results is comparable to the conventional radiotherapy.

scholarly journals Efficacy of Contact Needle Therapy for Chemotherapy-Induced Peripheral Neuropathy

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Keiko Ogawa ◽  
Masao Ogawa ◽  
Koji Nishijima ◽  
Masaki Tsuda ◽  
Genichi Nishimura
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Peripheral Neuropathy ◽  
Breakthrough Pain ◽  
Chemotherapeutic Agents ◽  
Discontinuation Of Treatment ◽  
Before And After ◽  
The Common ◽  
Adequate Sample Size

Cancer chemotherapy-induced peripheral neuropathy (CIPN) often results in discontinuation of treatment with potentially useful anticancer drugs and may deteriorate the patient’s quality of life. This study investigated the effect of contact needle therapy (CNT) on CIPN caused by responsible chemotherapeutic agents as taxanes and oxaliplatin. Six patients with CIPN were treated with CNT. The severity of CIPN was evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 and FACT/GOG-Ntx before and after CNT. After the treatment, all of the patients showed some improvement. Four patients showed apparent improvement in breakthrough pain. One of the cases had difficulty in walking because of CIPN in lower extremities, but after 2 times of CNT, he could walk without pain and could continue the chemotherapy. Although its putative mechanisms remain elusive, CNT has strong potential as an adjunctive therapy in CIPN. Well-designed clinical trials with adequate sample size and power are necessary to confirm the findings of this study.

TICLOPIDINE AND PREVENTION OF ARTERIAL REOCCLUSION AFTER DIRECT PERIPHERAL VASCULAR SURGERY

1987 ◽  
Author(s):  
P Castelli ◽  
A Basellini ◽  
G B Agus ◽  
E Martelli ◽  
R Zucca
Keyword(s):  
Placebo Group ◽  
Active Treatment ◽  
Doppler Sonography ◽  
Group Versus ◽  
Control Group ◽  
Acute Ischemia ◽  
End Of Treatment ◽  
Late Thrombosis ◽  
Revascularization Surgery ◽  
To Receive

Late thrombosis after arterial revascularization surgery is a relatively frequent complication especially when the more peripheral districts are involved. Among the causes of these failures, in addition to progression of the atherosclerotic disease, the behavior of platelet aggregation is of particular importance. With the aim of preventing this pathology we performed two controlled clinical 6-month studies on patients undergoing thrombo-endoarterectomy (TEA) of the femoropopliteal district and on patients undergoing aortobifemoral bypass.In the first study 47 patients were randomly allocated to receive ticlopidine, 500 mg/day, (23 patients) or placebo (24 patients), and in the second study 125 patients were evaluated (25 treated with ticlopidine, 500 mg/day, and 100 controls).Physical examination, doppler sonography, angiography, and blood tests were performed on all patients at baseline, during and at the end of treatment.In the patients who underwent TEA of the femoropopliteal district doppler sonography revealed 3 reocclusions in the ticlopidine-treated patients versus 6 reocclusions and 6 significant stenoses in the placebo group (p = 0.007).Furthermore, clinical symptomatology persisted or reappeared in 5 patients in the ticlopidine group versus 15 in the placebo group (p = 0.003).The active treatment significantly reduced the incidence of acute ischemia. In the. patients who underwent a bypass 5 reocclusions were observed in the control group, whereas the bypass remained patent in all the patients who received the active treatment. Ticlopidine was well tolerated in all the patients and no alterations of blood composition or other side effects were observed.

scholarly journals Efficacy and Safety of Tenapanor in Patients with Hyperphosphatemia Receiving Maintenance Hemodialysis: A Randomized Phase 3 Trial

2019 ◽  
Vol 30 (4) ◽  
pp. 641-652 ◽  
Author(s):  
Geoffrey A. Block ◽  
David P. Rosenbaum ◽  
Andrew Yan ◽  
Glenn M. Chertow
Keyword(s):  
Placebo Group ◽  
Water Content ◽  
Mechanism Of Action ◽  
Elevated Serum ◽  
Group Versus ◽  
Serum Phosphate ◽  
Maintenance Hemodialysis ◽  
Withdrawal Period ◽  
Phase 3 ◽  
To Receive

BackgroundGuidelines recommend reducing elevated serum phosphate in patients with CKD. Tenapanor, a minimally absorbed inhibitor of gastrointestinal sodium/hydrogen exchanger 3 (NHE3), reduces paracellular phosphate transport.MethodsIn this phase 3 randomized, double-blind trial, we randomly assigned patients with hyperphosphatemia receiving maintenance hemodialysis to receive twice-daily oral tenapanor (3, 10, or 30 mg [the latter down-titrated, if needed]) for 8 weeks. Patients were then rerandomized 1:1 to receive either their previously assigned dose or placebo for a 4-week ‘withdrawal’ period. We measured serum phosphate levels over the course of the trial. The primary end point was mean change in serum phosphate over the 4-week withdrawal period for the tenapanor group (using pooled data) versus the placebo group.ResultsOf 219 patients randomized, 152 completed both study phases. During the initial 8-week treatment period, all three treatment groups experienced significant decreases in mean serum phosphate (reductions of 1.00, 1.02, and 1.19 mg/dl, corresponding to the 3, 10, and 30 mg [down-titrated] dose groups, respectively). Tenapanor also showed a significant benefit over placebo during the withdrawal period, with a mean increase of 0.85 mg/dl in the placebo group versus a mean increase of 0.02 mg/dl in the pooled tenapanor group. Adverse events were largely limited to softened stool and a modest increase in bowel movement frequency, resulting from increased stool sodium and water content, stemming from tenapanor’s mechanism of action.ConclusionsTenapanor significantly reduced elevated serum phosphate in patients with hyperphosphatemia receiving maintenance hemodialysis. Adverse effects were limited to those induced by its known mechanism of action, which increases stool sodium and water content.

scholarly journals Comparison of the Effects of Omega 3 and Vitamin E on Palcitaxel-Induced Peripheral Neuropathy

2018 ◽  
Vol 6 (10) ◽  
pp. 1857-1861 ◽  
Author(s):  
Ali Arash Anoushirvani ◽  
Laila Poorsaadat ◽  
Reza Aghabozorgi ◽  
Maryam Kasravi
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Vitamin E ◽  
Peripheral Neuropathy ◽  
Side Effect ◽  
Omega 3 ◽  
Exclusion Criteria ◽  
Routine Administration ◽  
Significant Difference

BACKGROUND: Paclitaxel-induced peripheral neuropathy is the most important side effect limiting the use of this medication. AIM: This study aimed to compare the effects of omega-3 and vitamin E on the incidence of peripheral neuropathy in patients receiving Taxol. METHODS: In this clinical trial, 63 patients who were a candidate for receiving taxol, were enrolled based on inclusion and exclusion criteria. In group O, patients received 640 mg omega-3 three times a day, and group E, received 300 mg vitamin E two times a day. Patients took the supplements up to three months after the onset of Taxol. Group P received placebo for a similar period. All patients referred to a neurologist for electrophysiological evaluation before the onset of chemotherapy and at months 1 and 3. The presence of neuropathy and its progression was recorded by the neurologist. RESULTS: Neurological examination in this study indicated that 6 patients (28.6%) in Group O, 7 patients (33.3%) in group E, and 15 patients (71.4%) in placebo group started peripheral neuropathy. There was a significant difference between intervention groups and the placebo group (p = 0.0001) and no significant difference between intervention groups (p = 0.751). CONCLUSION: Our data suggested that vitamin E and omega-3 may significantly reduce the incidence of Paclitaxel-induced peripheral neuropathy. Routine administration of such supplements that have no special side effect for patients under chemotherapy may greatly enhance their quality of life.

scholarly journals Neuropathy severity at the time of oxaliplatin treatment alteration in patients with colon cancer (Alliance A151912).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12090-12090
Author(s):  
Daniel Louis Hertz ◽  
Travis Dockter ◽  
Daniel V. Satele ◽  
Charles L. Loprinzi ◽  
Jennifer Le-Rademacher
Keyword(s):  
Colon Cancer ◽  
Peripheral Neuropathy ◽  
Dose Reduction ◽  
Oxaliplatin Treatment ◽  
End Of Treatment ◽  
Chi Squared ◽  
Few Data ◽  
Eortc Qlq ◽  
To Receive ◽  
Clinical Trial Information

12090 Background: Clinical guidelines recommend altering chemotherapy treatment by decreasing, delaying, or discontinuing dosing in patients (pts) experiencing chemotherapy-induced peripheral neuropathy (CIPN). There are few data available on clinical use of treatment alteration including the severity of CIPN at the time of alteration. Our objective was to investigate the incidence of oxaliplatin treatment alterations and CIPN severity at that time. Methods: This was a retrospective analysis of pts with colon cancer scheduled to receive oxaliplatin-containing combination chemotherapy on the N08CB trial of intravenous calcium and magnesium for prevention of CIPN. Dose alterations were not mandated by the N08CB protocol. Clinicians assessed CIPN using NCI-CTCAE V.4.0; pts used the sensory subscale of the EORTC-QLQ Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN8). Pts were classified as 1) completed oxaliplatin treatment without alteration, 2) dose reduction or delay due to CIPN, 3) discontinuation due to CIPN, 4) discontinuation due to other AE, or 5) discontinuation for another reason. Comparisons focused primarily on pts with alteration due to CIPN (groups 2 and/or 3) compared with pts completing treatment without alteration (group 1) using chi-squared and Kruskal-Wallis tests. Results: In this analysis of 350 N08CB pts, 135 (39%) completed oxaliplatin without treatment alteration, 70 (20%) had a dose reduction (n=66) or delay (n=4) due to CIPN and 35 (10%) discontinued early due to CIPN. Pts who experienced alterations due to CIPN were younger (p=0.0249) and more likely to be female (p=0.008). Clinician-assessed CIPN severity was greater in pts at the time of dose reduction or delay compared with CIPN severity at the end of treatment in pts with no alteration (p<0.0001). Pt-assessed CIPN severity was not different in pts who completed treatment without alteration compared to pts who had a dose reduction or delay (p=0.88) or a discontinuation (p=0.37). CIPN8 scores at cycle 4 were higher (worse) in pts who eventually had any alteration (i.e., reduction, delay, or discontinuation) compared to pts who completed treatment without any alteration (median CIPN8 11.5 vs. 7.7, p=0.023). Conclusions: Treatment alterations due to CIPN are relatively common in pts receiving adjuvant oxaliplatin for colon cancer and are associated with clinician-assessed but not pt-reported CIPN severity. Rapid CIPN8 increases early in treatment are indicative of increased likelihood of a future oxaliplatin treatment alteration, indicating a potential use of early monitoring and intervention. Support: UG1CA189823; https://acknowledgments.alliancefound.org. Clinical trial information: NCT01099449 (NCCTG N08CB).

Cytoprotective Effect of Tocotrienol-Rich Fraction and α-Tocopherol Vitamin E Isoforms Against Glutamate-Induced Cell Death in Neuronal Cells

2014 ◽  
Vol 84 (3-4) ◽  
pp. 0140-0151 ◽  
Author(s):  
Thilaga Rati Selvaraju ◽  
Huzwah Khaza’ai ◽  
Sharmili Vidyadaran ◽  
Mohd Sokhini Abd Mutalib ◽  
Vasudevan Ramachandran ◽  
...  
Keyword(s):  
Vitamin E ◽  
Cell Viability ◽  
Neuronal Cells ◽  
Positive Control ◽  
Post Treatment ◽  
Mitochondrial Activity ◽  
Before And After ◽  
Pre Treatment ◽  
Tocotrienol Rich Fraction ◽  
Major Mediator

Glutamate is the major mediator of excitatory signals in the mammalian central nervous system. Extreme amounts of glutamate in the extracellular spaces can lead to numerous neurodegenerative diseases. We aimed to clarify the potential of the following vitamin E isomers, tocotrienol-rich fraction (TRF) and α-tocopherol (α-TCP), as potent neuroprotective agents against glutamate-induced injury in neuronal SK-N-SH cells. Cells were treated before and after glutamate injury (pre- and post-treatment, respectively) with 100 - 300 ng/ml TRF/α-TCP. Exposure to 120 mM glutamate significantly reduced cell viability to 76 % and 79 % in the pre- and post-treatment studies, respectively; however, pre- and post-treatment with TRF/α-TCP attenuated the cytotoxic effect of glutamate. Compared to the positive control (glutamate-injured cells not treated with TRF/α-TCP), pre-treatment with 100, 200, and 300 ng/ml TRF significantly improved cell viability following glutamate injury to 95.2 %, 95.0 %, and 95.6 %, respectively (p < 0.05).The isomers not only conferred neuroprotection by enhancing mitochondrial activity and depleting free radical production, but also increased cell viability and recovery upon glutamate insult. Our results suggest that vitamin E has potent antioxidant potential for protecting against glutamate injury and recovering glutamate-injured neuronal cells. Our findings also indicate that both TRF and α-TCP could play key roles as anti-apoptotic agents with neuroprotective properties.

Melatonin Improves Lipid Profile and Ameliorates Lipid Peroxidation in Patients with Chronic Kidney Disease.

2018 ◽  
pp. 38-45
Keyword(s):  
Lipid Peroxidation ◽  
Placebo Group ◽  
Lipid Profile ◽  
Kidney Diseases ◽  
Oxidized Ldl ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Before And After ◽  
Inhibit Lipid Peroxidation ◽  
Controlled Clinical Study

Dyslipidemia and oxidative modifications of lipid are frequently associated in patients with chronic kidney diseases (CKD) and considered the most important risk factors for cardiovascular events. Melatonin is a well-known potent antioxidant and has beneficial effect on lipid metabolism. the study was designed to evaluate if Melatonin could improve lipid profile and ameliorates lipid peroxidation. This single blind placebo controlled clinical study carried out on 41 patients with CKD who were randomized into two groups, control groups (n=20) those who received placebo cap and melatonin group those who received 5mg melatonin (n=21). Lipid profile [total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL-C), low-density lipoprotein (LDL-C)] and parameters of lipid peroxidation [oxidized LDL (oxLDL) and malondialdehyde (MDA) were measured before and after 12 weeks of the treatment. After 12 weeks of treatment, melatonin significantly increased HDL-C and decreased LDL-C compared to the initial value. The elevation in HDL-C and reduction in LDL-C were significantly different from that in placebo group. Also, both oxLDL and MDA levels significantly lowered by melatonin compared to the baseline and to the placebo group. Collectively, the results of our study showed that melatonin has advantageous effect on lipid profile and inhibit lipid peroxidation in patients with CKD.

A STUDY ON THE VARIATION IN CA 72-4 LEVELS OF THE GASTRIC CANCER’S PATIENTS BEFORE AND AFTER SURGERY TREATMENT

2011 ◽  
pp. 81-87
Author(s):  
Thi Thu Huong Hoang ◽  
Minh Vuong Nguyen
Keyword(s):  
Gastric Cancer ◽  
Study Groups ◽  
University Hospital ◽  
Control Group ◽  
Central Hospital ◽  
Before And After

Objectives: Studying on the variation in CA 72-4 levels of the gastric cancer’s patients before and after 10 days and 30 days surgery treatment. Materials and methods: The studying group included 42 gastric cancer’s patients who were examinated and treated in cancerology service of Hue University Hospital and gastroenterology service of Hue Central Hospital. The control group included 30 healthy normal examinated at Hue University Hospital. The study groups were clinical, endoscopic anatopathologic examination diagnosed with gastric cancer and quantitative levels of CA 72-4 in three times points: before surgerying, after surgerying 10 days and 30 days postoperatively. Rerults: The concentration of CA 72-4 in gastric cancer’s patients was 10.06 ± 16.49 U/ml. Clearly higher than the control group 1.2 ± 0.4 U/ml(p <0.01). The rate increased levels of CA 72-4 in gastric cancer’s patients before surgerying was 27.5% and the control group was 0%. After 10 days of surgery, CA 72-4 level was 5.56 ± 8.55 U/ml; 82.5% of patients have reduced levels of CA 72-4 and 17.5% no changes; there are 0% increased cases. After 30 days of surgery, CA 72-4 level was 3.79 ± 6,52 U/ml. CA 72-4 level 10 days after surgering have decreased significantly compared to before surgery (p < 0.05) and 30 days after surgery have decreased significantly compared to after 10 days (p < 0.05). 30 days postoperatively, 90% patients had reduced levels of CA 72-4, 10% no changes, no patient had increased levels of CA 72-4 and no patient be relapsed after 30 days of treatment. Conclusions: CA 72-4 concentrations before surgerying increased 27.5%, after surgery 10 days and 30 days reduced step by step, no case have increased CA 72-4 levels, no case relapsed after 30 days.

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