Evaluating the effects of duloxetine on prophylaxis of oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer: A randomized double-blind placebo controlled clinical trial

2021 ◽  
pp. 107815522110526
Author(s):  
Soufi Rokhsareh ◽  
Shirin Haghighi ◽  
Maria Tavakoli-Ardakani
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Peripheral Neuropathy ◽  
Chemotherapy Regimen ◽  
Gynecologic Oncology ◽  
Gynecologic Oncology Group ◽  
Double Blind ◽  
Gi Cancer ◽  
Tertiary Teaching ◽  
Analysis Of Results

Background Oxaliplatin is a key drug in treatment of gastrointestinal (GI) cancer. Peripheral neuropathy (PN) is a troublesome and dose-dependent adverse effect of oxaliplatin. It can occur in two distinct forms: acute and chronic. Its incidence is estimated about 65-98%, of which 22% of cases need to stop chemotherapy. In some cases, PN has a long-lasting effect on patient's quality of life (QOL). Therefore, this study was done to evaluate efficacy of duloxetine on prevention of oxaliplatin- induced peripheral neuropathy (OIPN) in patients with GI cancer. Methodology In this randomized and double -blind clinical trial study conducted in a tertiary teaching hospital, eligible patients were divided into two groups. Treatment group received duloxetine the day before initiation of chemotherapy regimen at a dose of 30 mg/day for one week and then, the dose was titrated up to 60 mg/day until 12 weeks. For placebo group, one placebo capsule was prescribed daily for one week followed by 2 capsules daily until 12 weeks. In each of chemotherapy courses, PN was assessed using national cancer institute-common terminology criteria for adverse effects (NCI-CTCAE v4.03). Also, chemotherapy -related QOL at the baseline and 12 weeks was assessed by functional assessment of cancer treatment gynecologic oncology group - neurotoxicity (FACT/GOG-NTX). Results Forty patients were randomly assigned to treatment and placebo groups which were similar to each other in terms of chemotherapy regimen, type, and stage of cancer. Analysis of results obtained from the NCI-CTCAE (v4.03) showed that duloxetine could prevent worsening of paresthesia more than placebo ( P = 0.025) and patients in duloxetine group experienced less peripheral sensory neuropathy ( P = 0.001) than placebo group. Analysis of results obtained from the FACT/GOG-NTX demonstrated a significant worsening of tingling and discomfort in hands ( P = 0.002, 0.001, respectively) and feet ( P = 0.017, 0.019, respectively) in placebo group compared to duloxetine group. Also, patients experienced more cold temperature -induced pain in extremities ( P = 0.001) in placebo group compared to duloxetine group. On the other hand, duloxetine could not improve QOL ( P = 0.06) and had not significant effects on trouble feeling the shape of small objects in hand ( P = 0.420) or trouble buttoning buttons ( P = 0.086). The P-value < 0.05 was considered to be statistically significant.

scholarly journals Evaluating the Effects of Duloxetine on oxaliplatin Induced Peripheral Neuropathy Prophylaxis in Gastrointestinal Cancer Patients, randomized double-blind placebo controlled clinical Trial

2020 ◽  
Author(s):  
rokhsareh soufi ◽  
Maria Tavakoli Ardakani ◽  
shirin haghighi
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Peripheral Neuropathy ◽  
Chemotherapy Regimen ◽  
Double Blind ◽  
Cancer Data ◽  
Gi Cancer ◽  
Tertiary Teaching ◽  
Hands And Feet

Abstract Backgroundoxaliplatin is a key drug in gastrointestinal (GI) cancer treatment. Peripheral Neuropathy is a troublesome and dose-dependent adverse effect of oxaliplatin. It can occur in two distinct forms: acute and chronic. Its incidence is estimated about 65-98 percent, of which 22 percent needed to stop chemotherapy. In some cases peripheral neuropathy has a long lasting impact on patient’s quality of life. The purpose of this study is to evaluate the efficacy of duloxetine on the prevention of oxaliplatin induced peripheral neuropathy in GI cancer patients.MethodsIn this randomized and double blind study, which was conducted in a tertiary teaching hospital, eligible patients were divided in to two groups. Treatment group was received Duloxetine the day before chemotherapy regimen initiation with the dose of 30 mg/day for one week and then was titrated up to 60 mg/day until 12 weeks. One placebo capsule daily for one week then two capsules daily until 12 weeks was prescribed for placebo group. In every chemotherapy courses peripheral neuropathy was assessed by using NCI-CTCAE v4.03. Also chemotherapy related quality of life (QOL) at the baseline and 12 weeks was assessed by using FACT/GOG-NTX.ResultsForty patients were randomized to the treatment and placebo group which were similar with chemotherapy regimen, type and stage of cancer. Data analysis of NCI-CTCAE showed duloxetine could prevent worsening of paresthesia more than placebo (P = 0.025) and patients in duloxetine group experience less peripheral sensory neuropathy (P = 0.001) than placebo. FACT/GOG-NTX analysis showed significant worsening of tingling and discomfort in hands (respectively P = 0.002, 0.001) and feet (respectively P = 0.017, 0.019), having pain in hands and feet (P = 0.001) and difficulty breathing in cold temperature exposure (P = 0.023) in placebo compared with duloxetine group. In the other hand, duloxetine could not improve QOL (P = 0.06) and hadn’t significant effects on Trouble feeling the shape of small objects in hand (P = 0.420) or Trouble buttoning buttons (P = 0.086).ConclusionDuloxetine can consider as a safe and effective medication for the prevention of oxaliplatin induced peripheral neuropathy in GI cancer. Nonetheless, more studies with larger population are needed.Trial registrationIRCT20100127003210N15. Registered 25 Jun 2018, https://fa.irct.ir/user/trial/3256/view

TJ-107 for the prevention of oxaliplatin-induced peripheral neuropathy: Results of a phase II randomized placebo-controlled clinical trial.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 567-567
Author(s):  
Toru Kono ◽  
Taishi Hata ◽  
Yoshinori Munemoto ◽  
Takanori Matsui ◽  
Hiroshi Kojima ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Peripheral Neuropathy ◽  
Cancer Patients ◽  
Phase Ii ◽  
Gynecologic Oncology ◽  
Phase Iii ◽  
Chemotherapy Response ◽  
Gynecologic Oncology Group ◽  
Response To Chemotherapy ◽  
Patient Reported

567 Background: Oxaliplatin-induced peripheral neuropathy (OPN) continues to be a substantial problem for many cancer patients. In light of the promising data on TJ-107 from a previous pilot study (ASCO-GI, 2009), the present clinical trial was conducted to evaluate its efficacy for the prevention of OPN. To determine whether TJ-107 given as an adjuvant therapy effectively prevents oxaliplatin-induced peripheral neuropathy Methods: A phase II, randomized, double-blind, placebo-controlled trial was conducted in colorectal cancer patients undergoing therapy with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX). TJ-107 (7.5g) or matching placebo was orally administered three times daily. The primary endpoint was the incidence of grade 2 or greater OPN according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version 3) criteria after 8 cycles of chemotherapy. Patient-reported neurotoxicity symptoms were also assessed using the neurotoxicity subscale of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group–Neurotoxicity (FACT/GOG-Ntx, version 4). Secondary endpoints included the incidence of all grades of OPN after each cycle and chemotherapy response rates. Results: A total of 93 patients were enrolled from May 1, 2009 to March 31, 2010 at 37 participating GONE trial institutions in Japan. Eighty-nine evaluable patients were randomized to either the TJ-107 group (n = 44) or the placebo group (n = 45). Placebo patients showed a significantly higher rate of neurotoxicity than that of TJ-107 patients (p < 0.001), with the median difference in NTX-12 score of 3 and 3.5 at the 8th week and 26th week, respectively. There were no significant between-group differences in response to chemotherapy (55.5% in TJ-107, 39.1% in placebo). In addition, TJ-107 treatment was well tolerated overall. Conclusions: TJ-107 shows promise in reducing the incidence of OPN. Further investigation in a larger phase III trial is necessary before any conclusions can be drawn. [Table: see text]

Efficacy of topical Citrullus colocynthis (bitter apple) extract oil in chemotherapy‐induced peripheral neuropathy: A pilot double‐blind randomized placebo‐controlled clinical trial

2019 ◽  
Vol 33 (10) ◽  
pp. 2685-2691 ◽  
Author(s):  
Nematollah Rostami ◽  
Seyed Hamdollah Mosavat ◽  
Ghazaleh Heydarirad ◽  
Roya Arbab Tafti ◽  
Mojtaba Heydari
Keyword(s):  
Clinical Trial ◽  
Peripheral Neuropathy ◽  
Controlled Clinical Trial ◽  
Citrullus Colocynthis ◽  
Double Blind

Value of Whole-Body Washing With Chlorhexidine for the Eradication of Methicillin-ResistantStaphylococcus aureus:A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

2007 ◽  
Vol 28 (9) ◽  
pp. 1036-1043 ◽  
Author(s):  
C. Wendt ◽  
S. Schinke ◽  
M. Württemberger ◽  
K. Oberdorfer ◽  
O. Bock-Hensley ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Treatment Group ◽  
Solution Treatment ◽  
University Hospital ◽  
Whole Body ◽  
Double Blind ◽  
Antiseptic Solution ◽  
Double Blind Clinical Trial ◽  
Double Blinded

Background.Whole-body washing with antiseptic solution has been widely used as part of eradication treatment for colonization with methicillin-resistantStaphylococcus aureus(MRSA), but evidence for the effectiveness of this measure is limited.Objective.To study the efficacy of whole-body washing with chlorhexidine for the control of MRSA.Design.Randomized, placebo-controlled, double-blinded clinical trial.Setting.University Hospital of Heidelberg and surrounding nursing homes.Patients.MRSA carriers who were not treated concurrently with antibiotics effective against MRSA were eligible for the study.Intervention.Five days of whole-body washing with either 4% chlorhexidine solution (treatment group) or with a placebo solution. All patients received mupirocin nasal ointment and chlorhexidine mouth rinse. The outcome was evaluated 3, 4, 5, 9, and 30 days after treatment with swab samples taken from several body sites.Results.Of 114 patients enrolled in the study (56 in the treatment group and 58 in the placebo group), 11 did not finish treatment (8 from the treatment group and 3 from the placebo group [P= .02]). At baseline, the groups did not differ with regard to age, sex, underlying condition, site of MRSA colonization, or history of MRSA eradication treatment. Eleven patients were MRSA-free 30 days after treatment (4 from the treatment group and 7 from the placebo group [P= .47]). Only groin-area colonization was significantly better eradicated by the use of chlorhexidine. The best predictor for total eradication was a low number of body sites positive for MRSA. Adverse effects were significantly more frequent in the treatment group than in the placebo group (any symptom, 71% vs 33%) but were reversible in most cases.Conclusion.Whole-body washing can reduce skin colonization, but it appears necessary to extend eradication measures to the gastrointestinal tract, wounds, and/or other colonized body sites if complete eradication is the goal.Trial Registration.ClinicalTrials.gov identifier: NCT00266448.

scholarly journals Subcutaneous granulocyte colony-stimulating factor administration for subacute traumatic spinal cord injuries, report of neurological and functional outcomes: a double-blind randomized controlled clinical trial

2019 ◽  
Vol 30 (1) ◽  
pp. 19-30 ◽  
Author(s):  
Nazi Derakhshanrad ◽  
Hooshang Saberi ◽  
Mir Saeed Yekaninejad ◽  
Mohammad Taghi Joghataei
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Placebo Group ◽  
Spinal Cord Injuries ◽  
Functional Improvement ◽  
Granulocyte Colony Stimulating Factor ◽  
Double Blind ◽  
Cord Injury ◽  
The Mean ◽  
Stimulating Factor

OBJECTIVEGranulocyte-colony stimulating factor (G-CSF) is a major cytokine that has already been clinically verified for chronic traumatic spinal cord injuries (TSCIs). In this study, the authors set out to determine the safety and efficacy of G-CSF administration for neurological and functional improvement in subacute, incomplete TSCI.METHODSThis phase II/III, prospective, double-blind, placebo-controlled, parallel randomized clinical trial was performed in 60 eligible patients (30 treatment, 30 placebo). Patients with incomplete subacute TSCIs with American Spinal Injury Association Impairment Scale (AIS) grades B, C, and D were enrolled. Patients were assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale, Spinal Cord Independence Measure (SCIM-III) and International Association of Neurorestoratology Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS), just before intervention and at 1, 3, and 6 months, after 7 daily subcutaneous administrations of 300 μg/day of G-CSF in the treatment group and placebo in the control group.RESULTSAmong 60 participants, 28 patients (93.3%) in the G-CSF group and 26 patients (86.6%) in the placebo group completed the study protocol. After 6 months of follow-up, the AIS grade remained unchanged in the placebo group, while in the G-CSF group 5 patients (45.5%) improved from AIS grade B to C, 5 (45.5%) improved from AIS grade C to grade D, and 1 patient (16.7%) improved from AIS grade D to E. The mean ± SEM change in ISNCSCI motor score in the G-CSF group was 14.9 ± 2.6 points, which was significantly greater than in the placebo group (1.4 ± 0.34 points, p < 0.001). The mean ± SEM light-touch and pinprick sensory scores improved by 8.8 ± 1.9 and 10.7 ± 2.6 points in the G-CSF group, while those in the placebo group improved by 2.5 ± 0.60 and 1.2 ± 0.40 points, (p = 0.005 and 0.002, respectively). Evaluation of functional improvement according to the IANR-SCIFRS instrument revealed significantly more functional improvement in the G-CSF group (10.3 ± 1.3 points than in the placebo group (3.0 ± 0.81 points; p < 0.001). A significant difference was also observed between the 2 groups as measured by the SCIM-III instrument (29.6 ± 4.1 vs 10.3 ± 2.2, p < 0.001).CONCLUSIONSIncomplete subacute TSCI is associated with significant motor, sensory, and functional improvement after administration of G-CSF.Clinical trial registration no.: IRCT201407177441N3 (www.irct.ir)

scholarly journals The efficacy of trimethoprim-sulfamethoxazole treatment in children with acute bloody diarrhea

2007 ◽  
Vol 47 (1) ◽  
pp. 17
Author(s):  
Selvi Nafianti ◽  
Oke R. Ramayani ◽  
Dedy G. Daulay ◽  
Supriatmo Supriatmo ◽  
Berlian Hasibuan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Developing Countries ◽  
Placebo Group ◽  
Campylobacter Jejuni ◽  
Bloody Diarrhea ◽  
Fecal Analysis ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Stool Analysis

Background The etiologies of bloody diarrhea are shigella,amoeba, enterocolitis, trichuriasis, and other causes i.e, EIEC,Campylobacter jejuni or rotavirus. In developing countries,trimetroprim-sulfamethoxazole (TMP-SMP) is effective in 80%of children with bloody diarrhea.Objective To determine the efficacy of trimethoprim-sulfa-methoxazole (TMP-SMX) treatment in children with acute bloodydiarrhea.Methods A randomized double blind clinical trial was conductedin Adam Malik Hospital and Dr. Pirngadi Hospital Medan duringSeptember 2003-March 2004. Children aged 2-24 months oldwith diagnosis of acute bloody diarrhea were randomized into twogroups to either receive TMP-SMX or placebo for 5 days.Microscopic fecal analysis was performed on the first, second,fifth and twelfth day, and the results were compared.Results A total of 68 children consisted of 48 (71%) boys and 20(29%) girls were enrolled. Each group had 34 participants.Analysis of the first day showed leukocyte and erythrocyte in thestool specimens, which were all absent on the twelfth day in bothgroups. There was no difference in stool analysis between TMP-SMX and placebo group in day two (P=0.758), day five (P=0.341)and day twelve. Diarrhea duration in TMP-SMX and placebogroup was 7.18 days and 6.65 days, respectively. This differentwas statistically not significant (P=0.385).Conclusion There is no difference in the efficacy of trimethoprim-sulfamethoxazole treatment compared to placebo in children withacute bloody diarrhea.

scholarly journals Bevacizumab use in the frontline, maintenance and recurrent settings for ovarian cancer

2020 ◽  
Vol 16 (7) ◽  
pp. 225-246 ◽  
Author(s):  
Carolyn E Haunschild ◽  
Krishnansu S Tewari
Keyword(s):  
Ovarian Cancer ◽  
Gynecologic Oncology ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Double Blind ◽  
Free Survival ◽  
Platinum Sensitive ◽  
The Us ◽  
Us Fda

On 13 June 2018, Genentech, Inc. issued a press release announcing that the US FDA had approved the antiangiogenesis drug, bevacizumab, in combination with chemotherapy for frontline and maintenance therapy for women with newly diagnosed ovarian cancer. Regulatory approval was based on the National Cancer Institute-sponsored Gynecologic Oncology Group (GOG) protocol 0218, the Phase III, randomized, placebo-controlled, double-blind, multi-center and multi-national clinical trial that met its primary end point, progression-free survival. Bevacizumab is now approved in the frontline, platinum-sensitive recurrent and platinum-resistant recurrent settings for epithelial ovarian cancer. This review will address the broad range of clinical trials addressing the efficacy of bevacizumab use in ovarian cancer.

scholarly journals A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3794
Author(s):  
Yu Hwa Park ◽  
Do Hoon Kim ◽  
Jung Suk Lee ◽  
Hyun Il Jeong ◽  
Kye Wan Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Uric Acid ◽  
Placebo Group ◽  
Serum Uric Acid ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Food Ingredient ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of Chrysanthemum indicum Linn flower extract and Cinnamomum cassia extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0–9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (p = 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (p = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (p = 0.0324), a statistically significant difference (p = 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (p = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (p = 0.2187), a statistically significant difference between the administration groups (p = 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.

scholarly journals Zinc supplementation improves body weight management, inflammatory biomarkers and insulin resistance in individuals with obesity: a randomized, placebo-controlled, double-blind trial

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Hoda Khorsandi ◽  
Omid Nikpayam ◽  
Reyhaneh Yousefi ◽  
Maryam Parandoosh ◽  
Nima Hosseinzadeh ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Clinical Trial ◽  
Body Weight ◽  
Placebo Group ◽  
Zinc Supplementation ◽  
Energy Requirement ◽  
Anthropometric Measurements ◽  
Model Assessment ◽  
Double Blind ◽  
Calorie Diet

Abstract Background The present study was designed to determine whether zinc supplementation would increase the effects of restricted calorie diet (RCD) on obesity. Methods and materials A randomized, double-blind clinical trial was performed on 40 obese subjects who were randomly assigned to receive zinc supplements (30 mg/day) or placebo for a period of 15-weeks. Both groups were under a restricted calorie diet (~ 300 kcal lower than the estimated energy requirement). Anthropometric measurements, biochemical markers, appetite, and dietary intakes were determined during the study period. Results The reductions of body weight, body mass index, waist circumference, and hip circumference were significantly higher in the zinc group compared to the placebo group (P = 0.032, 0.025, 0.003, and 0.0001, respectively). Lower levels of high sensitivity C-reactive protein, apelin, homeostatic model assessment of insulin resistance (HOMA-IR), and appetite score were observed in the zinc group in comparison with the placebo group (P = 0.0001, 0.001, 0.031 and 0.001 respectively). Conclusion This study indicates that Zn supplementation with a restricted calorie diet has favorable effects in reducing anthropometric measurements, inflammatory markers, insulin resistance and appetite in individuals with obesity, and may play an effective role in the treatment of obesity. Trial registration This clinical trial was registered at clinicaltrials.gov at the U.S. National Library of Medicine (NCT02516475).

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