Neuroprotective Effect of Reduced Glutathione on Oxaliplatin-Based Chemotherapy in Advanced Colorectal Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial

2002 ◽  
Vol 20 (16) ◽  
pp. 3478-3483 ◽  
Author(s):  
Stefano Cascinu ◽  
Vincenzo Catalano ◽  
Luigi Cordella ◽  
Roberto Labianca ◽  
Paolo Giordani ◽  
...  
Keyword(s):  
Saline Solution ◽  
Neuroprotective Effect ◽  
Controlled Trial ◽  
Sensory Nerve ◽  
Clinical Activity ◽  
Double Blind ◽  
Double Blind Placebo ◽  
To Receive ◽  
Infusion Period ◽  
Toxicity Criteria

PURPOSE: We performed a randomized, double-blind, placebo-controlled trial to assess the efficacy of glutathione (GSH) in the prevention of oxaliplatin-induced neurotoxicity. PATIENTS AND METHODS: Fifty-two patients treated with a bimonthly oxaliplatin-based regimen were randomized to receive GSH (1,500 mg/m2 over a 15-minute infusion period before oxaliplatin) or normal saline solution. Clinical neurologic evaluation and electrophysiologic investigations were performed at baseline and after four (oxaliplatin dose, 400 mg/m2), eight (oxaliplatin dose, 800 mg/m2), and 12 (oxaliplatin dose, 1,200 mg/m2) cycles of treatment. RESULTS: At the fourth cycle, seven patients showed clinically evident neuropathy in the GSH arm, whereas 11 patients in the placebo arm did. After the eighth cycle, nine of 21 assessable patients in the GSH arm suffered from neurotoxicity compared with 15 of 19 in the placebo arm. With regard to grade 2 to 4 National Cancer Institute common toxicity criteria, 11 patients experienced neuropathy in the placebo arm compared with only two patients in the GSH arm (P = .003). After 12 cycles, grade 2 to 4 neurotoxicity was observed in three patients in the GSH arm and in eight patients in the placebo arm (P = .004). The neurophysiologic investigations (sural sensory nerve conduction) showed a statistically significant reduction of the values in the placebo arm but not in the GSH arm. The response rate was 26.9% in the GSH arm and 23.1% in the placebo arm, showing no reduction in activity of oxaliplatin. CONCLUSION: This study provides evidence that GSH is a promising drug for the prevention of oxaliplatin-induced neuropathy, and that it does not reduce the clinical activity of oxaliplatin.

Neuroprotective effect of reduced glutathione on cisplatin-based chemotherapy in advanced gastric cancer: a randomized double-blind placebo-controlled trial.

1995 ◽  
Vol 13 (1) ◽  
pp. 26-32 ◽  
Author(s):  
S Cascinu ◽  
L Cordella ◽  
E Del Ferro ◽  
M Fronzoni ◽  
G Catalano
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Normal Saline ◽  
Saline Solution ◽  
Neuroprotective Effect ◽  
Controlled Trial ◽  
Sensory Nerve ◽  
Complete Response ◽  
Double Blind ◽  
Double Blind Placebo

PURPOSE We performed a randomized double-blind placebo-controlled trial to assess the efficacy of glutathione (GSH) in the prevention of cisplatin (CDDP)-induced neurotoxicity. PATIENTS AND METHODS Fifty patients with advanced gastric cancer treated with a weekly CDDP-based regimen were included in this study. In patients randomized to receive GSH, GSH was given at a dose of 1.5 g/m2 in 100 mL of normal saline solution over a 15-minute period immediately before CDDP administration, and at a dose of 600 mg by intramuscular injection on days 2 to 5. Normal saline solution was administered to placebo-randomized patients. Clinical neurologic evaluation and electrophysiologic investigations have been performed at baseline and after 9 (CDDP dose, 360 mg/m2) and 15 (CDDP dose, 600 mg/m2) weeks of treatment. RESULTS At the 9th week, no patients showed clinically evident neuropathy in the GSH arm, whereas 16 patients in the placebo arm did. After the 15th week, four of 24 assessable patients in the GSH arm suffered from neurotoxicity versus 16 of 18 in the placebo arm (P = .0001). In confirmation of this neuroprotective effect, the neurophisiologic investigations, based on the evaluation of the median, ulnar, and sural sensory nerve conduction, showed a statistically significant reduction of these values in the placebo arm but not in the GSH arm, above all considering potential amplitude. In this trial, GSH also reduced hemotransfusion requirements (32 v 62 hemotransfusions) and treatment delay (55 v 94 weeks). The response rate was 76% (20% complete response) in the GSH group and 52% (12% complete response) in the placebo arm, confirming preliminary reports about the lack of reduction in activity of cytotoxic drugs induced by GSH. CONCLUSION This study provides evidence that GSH is a promising and effective new drug for the prevention of CDDP-induced neuropathy, and that it does not reduce the clinical activity of chemotherapeutic drugs.

scholarly journals Efficacy of a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 in hospital personnel dedicated to patients care with COVID-19 disease. A pragmatic multicenter, randomized, double-blind, placebo-controlled trial (CARR-COV-02)

2021 ◽  
Author(s):  
Juan Manuel Figueroa ◽  
Monica Lombardo ◽  
Ariel Dogliotti ◽  
Luis Flynn ◽  
Robert P. Giugliano ◽  
...  
Keyword(s):  
Placebo Group ◽  
Nasal Spray ◽  
Controlled Trial ◽  
Hospital Personnel ◽  
Culture Methods ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Efficacy ◽  
To Receive

Background Iota-Carrageenan (I-C) is a sulfate polysaccharide synthesized by red algae, with demonstrated antiviral activity and clinical efficacy as nasal spray in the treatment of common cold. In vitro, I-C inhibits SARS-CoV-2 infection in cell culture. Methods This is a pragmatic multicenter, randomized, double-blind, placebo-controlled trial assessing the use of a nasal spray containing I-C in the prophylaxis of COVID-19 in hospital personnel dedicated to care of COVID-19 patients. Clinically healthy physicians, nurses, kinesiologists and others medical providers were assigned in a 1:1 ratio to receive four daily doses of I-C spray or placebo for 21 days. The primary end point was clinical COVID-19, as confirmed by reverse-transcriptase-polymerase-chain-reaction testing, over a period of 21 days. The trial is registered at ClinicalTrials.gov (NCT04521322). Findings A total of 394 individuals were randomly assigned to receive I-C or placebo. Both treatment groups had similar baseline characteristics. The incidence of COVID-19 was significantly lower in the I-C group compared to placebo (1.0% vs 5.0%) (Odds Ratio 0.19 (95% confidence interval 0.05 to 0.77; p= 0.03). Workday loss in placebo group compared to I-C were 1.6% days / person (95% CI, 1.0 to 2.2); p <0.0001 There were no differences in the incidence of adverse events across the two groups (17.3% in the I-C group and 15.2% in the placebo group, p= 0.5). Interpretation I-C showed significant efficacy in preventing SARS-CoV-2 infection in hospital personnel dedicated to care patients with COVID-19 disease.

scholarly journals Efficacy of Standardized Extract ofBacopa monnieri(Bacognize®) on Cognitive Functions of Medical Students: A Six-Week, Randomized Placebo-Controlled Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Navneet Kumar ◽  
L. G. Abichandani ◽  
Vijay Thawani ◽  
K. J. Gharpure ◽  
M. U. R. Naidu ◽  
...  
Keyword(s):  
Medical Students ◽  
Cognitive Functions ◽  
Controlled Trial ◽  
Bacopa Monnieri ◽  
Normal Range ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Medical College ◽  
Second Year ◽  
To Receive

Rationale.Bacopa monnieri, popularly known as Brahmi, has been traditionally used in Ayurveda since ages for its memory enhancing properties. However, data on placebo-controlled trial ofBacopa monnierion intellectual sample is scarce. Hence this study was planned to evaluate the effect ofBacopa monnierion memory of medical students for six weeks.Objective. To evaluate the efficacy ofBacopa monnierion memory of medical students with six weeks’ administration.Method and Material. This was a randomized double blind placebo-controlled noncrossover, parallel trial. Sixty medical students of either gender from second year of medical school, third term, regular batch, were enrolled from Government Medical College, Nagpur, India. Baseline biochemical and memory tests were done. The participants were randomly divided in two groups to receive either 150 mg of standardized extract ofBacopa monnieri(Bacognize) or matching placebo twice daily for six weeks. All baseline investigations were repeated at the end of the trial. Students were followed up for 15 days after the intervention.Results. Statistically significant improvement was seen in the tests relating to the cognitive functions with use ofBacopa monnieri. Blood biochemistry also showed a significant increase in serum calcium levels (still within normal range).

Clonidine is not a Useful Adjunct to Methadone Gradual Detoxification in Opioid Addiction

1994 ◽  
Vol 165 (3) ◽  
pp. 370-374 ◽  
Author(s):  
Hamid Ghodse ◽  
Judith Myles ◽  
Stephen E. Smith
Keyword(s):  
Blood Pressure ◽  
Clinical Examination ◽  
Drug Dependence ◽  
Controlled Trial ◽  
Double Blind ◽  
Treatment Unit ◽  
Double Blind Placebo ◽  
To Receive ◽  
Drug Dependence Treatment

BackgroundThe role of clonidine in the management of opioid-dependent individuals undergoing gradual detoxification.MethodA double-blind placebo-controlled trial was conducted on 86 voluntary in-patients (59 male, 27 female) aged 18–47 years, at a specialist drug-dependence treatment unit. Patients entered the trial when on 40 mg of methadone daily or less, and were randomised to receive incremental doses of clonidine (increasing from 0.2 mg daily to 1.2 mg daily) during a 14-day period of gradual methadone detoxification and for four weeks thereafter. Blood pressure was monitored and severity of opioid abstinence was assessed by questionnaire and by clinical examination.ResultHalf the subjects were withdrawn or defaulted from the trial by the end of two weeks, those receiving clonidine earlier than those receiving dummy medication (9 of the former and only one of the latter because of systemic hypotension). Similar proportions of subjects completed detoxification in the two groups. In those who completed detoxification, clonidine did not significantly reduce either the symptoms or objective signs of opioid withdrawal.ConclusionsThese findings suggest that clonidine has no place as an adjunct to a programme of gradual opioid detoxification.

scholarly journals Comparison of azithromycin vs doxycycline prophylaxis in leptospirosis, A randomized double blind placebo-controlled trial

2018 ◽  
Vol 12 (11) ◽  
pp. 991-995
Author(s):  
Ahmad Alikhani ◽  
Ebrahim Salehifar ◽  
Fatemeh Zameni ◽  
Alireza Rafiei ◽  
Jamshid Yazdani-charati ◽  
...  
Keyword(s):  
Paddy Field ◽  
Controlled Trial ◽  
Fisher Exact Test ◽  
Mazandaran Province ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Informed Consent Form ◽  
Significant Difference ◽  
Field Workers ◽  
To Receive

Introduction: Leptospirosis is an important zoonotic disease in paddy field with 29.5% prevalence rate in Mazandaran province and 4% to 52% mortality rate among hospitalized patients. Prevention is an important strategy for the control of this disease. This study aimed to compare the prophylactic effect of azithromycin versus doxycycline against leptospirosis in an endemic area in north of Iran. Methodology: In this randomized double-blind placebo-controlled trial, paddy field workers (n = 187) were randomized to receive azithromycin (500mg weekly), doxycycline (200 mg weekly) or placebo starting one week before exposure to paddy field, during and to four weeks after. Paddy field workers aged 18- 65 years who signed the informed consent form were assessed for signs and symptoms of leptospirosis in addition to serologic evidence of the disease 6th and 12th week. Data were analyzed with SPSS version 13 using Chi-square and Fisher exact test and ANOVA. Results: From June to September 2016, 187 participants were entered the study to receive azithromycin (n = 66), doxycycline (n = 71) or placebo (n = 50). In terms of preventing against clinical leptospirosis, there was not any significant difference between three arms, though there was statistically significant difference of seropositivity after 6 and 12 weeks in comparison to baseline among all three groups (P = 0.029) and between active treatment (eg. azithromycin and doxycycline) groups and placebo group (P = 0.01). Conclusion: Azithromycin like doxycycline decreased seropositivity without significant effect on clinical leptospirosis.

A phase 3 (COSMIC-311), randomized, double-blind, placebo-controlled study of cabozantinib in patients with radioiodine (RAI)-refractory differentiated thyroid cancer (DTC) who have progressed after prior VEGFR-targeted therapy.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS6097-TPS6097 ◽  
Author(s):  
Marcia S. Brose ◽  
Bruce Robinson ◽  
Candy Bermingham ◽  
Soham Puvvada ◽  
Anne E. Borgman ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Targeted Therapy ◽  
Differentiated Thyroid Cancer ◽  
Controlled Trial ◽  
Objective Response ◽  
Controlled Study ◽  
Clinical Activity ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo

TPS6097 Background: Treatment options are limited for patients with RAI-refractory DTC that is resistant to VEGFR-targeted therapy. Cabozantinib inhibits receptor tyrosine kinases including VEGFR2, MET, AXL, and RET, which are implicated in the development of DTC, and has shown clinical activity in early-phase studies of patients with RAI-refractory DTC. This study evaluates the efficacy and safety of cabozantinib in patients with RAI-refractory DTC who have progressed during or after prior VEGFR-targeted therapy. Methods: This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial (NCT03690388). The co-primary endpoints are progression-free survival and objective response rate evaluated by blinded independent radiology committee (BIRC) per RECIST v 1.1. Additional endpoints include safety, overall survival, quality of life, and changes in relevant biomarker levels (eg, thyroglobulin). Approximately 300 patients will be randomized in a 2:1 ratio to receive either cabozantinib (60 mg QD orally) or placebo. Randomization is stratified by prior treatment with lenvatinib and age (≤ 65 yrs vs > 65 yrs). Eligible patients must have a pathologic diagnosis of DTC and must have been previously treated with or deemed ineligible for treatment with iodine-131 for DTC. Patients must have received lenvatinib or sorafenib for DTC and progressed during or following treatment with a VEGFR inhibitor. Up to 2 prior VEGFR-targeting TKI agents are allowed. Patients randomized to placebo may be eligible for real time on-study crossover to cabozantinib based on BIRC confirmation of disease progression. Unblinded patients randomized to cabozantinib may continue on study treatment if there is clinical benefit per investigator. Key words: Radioiodine-refractory differentiated thyroid cancer, cabozantinib, VEGFR-targeted therapy, trial-in-progress. Clinical trial information: NCT03690388.

Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Hematopoietic Growth Factor PIXY321 After Moderate-Dose Fluorouracil, Doxorubicin, and Cyclophosphamide in Stage II and III Breast Cancer

1999 ◽  
Vol 17 (10) ◽  
pp. 3025-3032 ◽  
Author(s):  
Stephen E. Jones ◽  
Pankaj Khandelwal ◽  
Kristi McIntyre ◽  
Robert Mennel ◽  
Douglas Orr ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Controlled Trial ◽  
Dose Intensity ◽  
Stage Ii ◽  
Moderate Dose ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Fac Chemotherapy ◽  
Grade 3 ◽  
To Receive

PURPOSE: To measure the effect of PIXY321 (granulocyte-macrophage colony-stimulating factor/interleukin-3 S. cerevisiae fusion protein) on the incidence, duration, and complications of neutropenia and thrombocytopenia after moderate-dose fluorouracil 600 mg/m2, doxorubicin 60 mg/m2, and cyclophosphamide 750 mg/m2 (FAC) chemotherapy in patients with stage II and III breast cancer. PATIENTS AND METHODS: In this multicenter, randomized, double-blind placebo-controlled trial, 71 women were to receive four 21-day cycles of treatment with moderate-dose FAC chemotherapy by short intravenous infusion on day 1, followed by either placebo or PIXY321 (375 μg/m2 subcutaneously twice a day) on days 3 to 15. All patients were to receive prophylactic oral ciprofloxacin when the absolute neutrophil count was less than 1,000/μL. RESULTS: PIXY321 significantly reduced the incidence and duration of grade 3 and grade 4 neutropenia in cycles 1 and 2 and the duration of grade 3 neutropenia in cycles 1 through 4. In cycles 3 and 4, grade 3 thrombocytopenia was significantly more common with PIXY321 (P < .05). Two patients, both in the PIXY321 group, required platelet transfusions. Fever and hospitalization for intravenous antibiotics were significantly more common in the PIXY321 group during cycle 1 only. More patients in the PIXY321 group achieved hematologic recovery by day 22 in cycles 1 through 3, and time to recovery was significantly shorter with PIXY321 in all cycles. FAC dose intensity was roughly 2% higher in the PIXY321 group (P = NS). Nonhematologic events of any intensity occurring with significantly greater overall frequency in the PIXY321 group included injection-site reactions, fever, chills, abdominal pain, and arthralgia. No patient died on study or within 30 days of her last dose of study drug. CONCLUSION: PIXY321 decreased the incidence and duration of FAC-induced grade 3 and 4 neutropenia in cycles 1 and 2 and significantly shortened the time to hematologic recovery in all cycles. However, it produced more systemic toxicity as well as thrombocytopenia in cycles 3 and 4.

Double-blind placebo-controlled study to evaluate the effect of pro-juven progesterone cream on atherosclerosis and bone density

2009 ◽  
Vol 15 (3) ◽  
pp. 100-106 ◽  
Author(s):  
Beverly Benster ◽  
Adam Carey ◽  
Fred Wadsworth ◽  
Maura Griffin ◽  
Andrew Nicolaides ◽  
...  
Keyword(s):  
Bone Density ◽  
Postmenopausal Women ◽  
Controlled Trial ◽  
Intima Media Thickness ◽  
Rate Of Change ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Arterial Plaque ◽  
To Receive

Objective To establish whether treatment for three years with pro-juven progesterone cream affects progression of atherosclerotic plaques or bone density in postmenopausal women. Design Randomized double-blind placebo-controlled trial. Sample One hundred and thirty-one healthy postmenopausal women aged between 50 and 75 years with at least one asymptomatic arterial plaque visible on ultrasound of the carotid or femoral bifurcation. Methods Women were randomly allocated to receive pro-juven progesterone cream, 20 mg twice daily, or placebo, for three years. Main outcome measure Rate of change of plaque thickness, intima-media thickness and bone density of lumbar spine and femoral neck. Results There was no difference between the groups. Conclusion Pro-juven progesterone cream 20 mg twice daily did not affect progression of asymptomatic atherosclerosis or deterioration in bone density over three years.

Sign in / Sign up

Export Citation Format

Share Document