scholarly journals Compression therapy using surgical gloves does not prevent paclitaxel-induced peripheral neuropathy: results from a double-blind phase 2 trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Haruru Kotani ◽  
Mitsuo Terada ◽  
Makiko Mori ◽  
Nanae Horisawa ◽  
Kayoko Sugino ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Primary Outcome ◽  
Compression Therapy ◽  
University Hospital ◽  
Double Blind Study ◽  
Double Blind ◽  
Prophylactic Measure ◽  
Weekly Chemotherapy ◽  
Surgical Gloves ◽  
And Control

Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of paclitaxel (PTX). There is no known prophylactic measure, although there are some reports of prevention with compression therapy using surgical gloves. On account of its predominantly subjective symptoms, it is difficult to exclude bias when assessing for CIPN. In this study, we assessed the effectiveness of the same procedure for the prevention of paclitaxel-induced PN based on a double-blind study design. Methods The patients with early and recurrent breast cancer (with no prior PTX exposure) initiating weekly chemotherapy with PTX 80 mg/m2 were enrolled. Each patient donned two gloves on each hand at every PTX infusion. Two one-size-smaller gloves were donned on one hand (study side) and two normal-size gloves were donned on the other hand (control side) during 90 min from 30 min before the infusion to 30 min after the end of the infusion. Study side are blind for both patients and assessing physicians according to determination of the study side by research nurses in the chemotherapy unit. The primary outcome was the difference in the frequency of CIPN (motor/sensory) determined by the physician using the common terminology criteria for adverse events (CTCAE v4.0), with an evaluation at each cycle of PTX infusion. McNemar test was used to assess the primary outcome. Results Between July 2017 and November 2018, 56 patients were enrolled and 49 patients were evaluated. Overall, Grade ≥ 2 PN (sensory) was observed in 30.6 and 36.7% in the study and control sides, respectively (McNemar p = 0.25). PN (motor) was observed in 4.1 and 6.1% in the study and control sides, respectively (McNemar p = 1.0). Conclusion Surgical glove compression therapy showed no statistically significant effect on the incidence of PTX-induced PN. Trial registrations This study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry managed by the National University Hospital Council of Japan (UMIN000027944). Registered 26 June 2017.

Compression Therapy Using Surgical Gloves Does Not Prevent Paclitaxel-induced Peripheral Neuropathy: Results From a Double-blind Phase 2 Trial 

2020 ◽  
Author(s):  
Haruru Kotani ◽  
Mitsuo Terada ◽  
Makiko Mori ◽  
Nanae Horisawa ◽  
Kayoko Sugino ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Primary Outcome ◽  
Compression Therapy ◽  
University Hospital ◽  
Double Blind Study ◽  
Double Blind ◽  
Prophylactic Measure ◽  
Weekly Chemotherapy ◽  
Surgical Gloves ◽  
And Control

Abstract Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of paclitaxel (PTX). There is no known prophylactic measure, although there are some reports of prevention with compression therapy using surgical gloves. On account of its predominantly subjective symptoms, it is difficult to exclude bias when assessing for CIPN. In this study, we assessed the effectiveness of the same procedure for the prevention of paclitaxel-induced PN based on a double-blind study design.Methods: The patients with early and recurrent breast cancer (with no prior PTX exposure) initiating weekly chemotherapy with PTX 80 mg/m2 were enrolled. Each patient donned two gloves on each hand at every PTX infusion. Two one-size-smaller gloves were donned on one hand (study side) and two normal-size gloves were donned on the other hand (control side) during 90 minutes from 30 minutes before the infusion to 30 minutes after the end of the infusion. Study side are blind for both patients and assessing physicians according to determination of the study side by research nurses in the chemotherapy unit.The primary outcome was the difference in the frequency of CIPN (motor/sensory) determined by the physician using the common terminology criteria for adverse events (CTCAE v4.0), with an evaluation at each cycle of PTX infusion. McNemar test was used to assess the primary outcome.Results: Between July 2017 and November 2018, 56 patients were enrolled and 49 patients were evaluated. Overall, Grade ≥ 2 PN (sensory) was observed in 30.6% and 36.7% in the study and control sides, respectively (McNemar p = 0.25). PN (motor) was observed in 4.1% and 6.1% in the study and control sides, respectively (McNemar p = 1.0). Conclusion: Surgical glove compression therapy showed no statistically significant effect on the incidence of PTX-induced PN.Trial registrations: This study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry managed by the National University Hospital Council of Japan (UMIN000027944).

scholarly journals Effectiveness assessment of riluzole in the prevention of oxaliplatin-induced peripheral neuropathy: RILUZOX-01: protocol of a randomised, parallel, controlled, double-blind and multicentre study by the UNICANCER-AFSOS Supportive Care intergroup

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e027770 ◽  
Author(s):  
Nicolas Kerckhove ◽  
Jérome Busserolles ◽  
Trevor Stanbury ◽  
Bruno Pereira ◽  
Valérie Plence ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Disease Free Survival ◽  
Sensory Neuropathy ◽  
Repeated Administration ◽  
Public Health Issue ◽  
Double Blind Study ◽  
Double Blind ◽  
Related Quality ◽  
Registration Number ◽  
Randomised Controlled

IntroductionMost patients (>70%) experience acute neuropathic symptoms shortly after oxaliplatin infusions. These symptoms are not always resolved between infusions. Overall, 30%–50% of patients suffer from chronic oxaliplatin-induced peripheral neuropathy (OIPN). This cumulative and dose-dependent sensory neuropathy limits compliance or results in oxaliplatin-based chemotherapies to be substituted with less neurotoxic agents. These treatment changes impair clinical outcomes, and may be associated with comorbidities, such as distress, depression and anxiety. Currently, no drug used to prevent or treat OIPN is sufficiently effective to be used routinely in clinical practice. There is, thus, an unmet therapeutic need to reduce the intensity of and/or prevent OIPN. We hypothesised that riluzole would be an excellent candidate to address this public health issue. Riluzole is approved for treating amyotrophic lateral sclerosis. In animals, there is a beneficial effect on sensorimotor and pain disorders, as well as related comorbidities, after repeated administration of oxaliplatin. In humans, riluzole has shown neuroprotective, anxiolytic and antidepressive effects.Methods and analysisRILUZOX-01 trial was designed as a randomised, controlled, double-blind study to evaluate the efficacy of riluzole to prevent OIPN. Patients with colorectal cancer and initiating adjuvant oxaliplatin-based chemotherapy are eligible. Patients (n=210) will be randomly assigned to either riluzole or placebo, concomitantly with chemotherapy. The primary endpoint is the change in OIPN intensity, assessed by the sensory scale of the QLQ-CIPN20, after six 2-week cycles of chemotherapy. Secondary endpoints include incidence and severity of neuropathy, grade of sensory neuropathy, intensity and features of neuropathic pain, health-related quality of life, disease-free survival, overall survival and safety.Ethics and dessiminationThe study was approved by a French ethics committee (ref:39/18_1, ‘Comité de Protection des Personnes’ Ouest-IV, France) and plans to start enroling patients in September 2019. The trial is registered in EudraCT and clinicaltrials.gov.Trial registration numberN°2017-002320-25;NCT03722680

Ten years' experience with liposomal amphotericin B in transplant recipients at Huddinge University Hospital

2002 ◽  
Vol 49 (suppl_1) ◽  
pp. 51-55 ◽  
Author(s):  
Olle Ringdén
Keyword(s):  
Bone Marrow ◽  
Bone Marrow Transplantation ◽  
Amphotericin B ◽  
Marrow Transplantation ◽  
Fungal Infections ◽  
University Hospital ◽  
Fungal Colonization ◽  
Double Blind Study ◽  
Transplant Recipients ◽  
Double Blind

Abstract Our substantial experience in several trials with AmBisome in adult and paediatric patients undergoing transplantation has shown this formulation of amphotericin B to be safe and effective in therapeutic and prophylactic use. AmBisome has shown a significant reduction in fungal colonization and invasive Candida infections compared with placebo in a prospec-tive, double-blind study in bone marrow transplantation, and eradication of invasive fungal infections in 86% of 14 children undergoing bone marrow transplantation. The main side effects of AmBisome use are elevations in serum potassium and creatinine, but these lead to very few withdrawals from treatment. Compared with conventional amphotericin B, AmBisome is very expensive, but its much improved safety profile and proven efficacy make it an excellent agent for management of invasive fungal disease in transplant recipients.

The effect of lavandula angustifolia in the treatment of depression

2011 ◽  
Vol 26 (S2) ◽  
pp. 624-624 ◽  
Author(s):  
N. Parvin ◽  
S. Farzaneh ◽  
M. Nikfarjam ◽  
N. Shahinfard ◽  
N. Asarzadegan
Keyword(s):  
Depression Score ◽  
Control Group ◽  
Case Group ◽  
Double Blind Study ◽  
Control Groups ◽  
Chi Square ◽  
Double Blind ◽  
Treatment Of Depression ◽  
Severity Of Depression ◽  
And Control

Background and aimMedical plants have been used for centuries as a medicinal agent in treatment of depression and anxiety. The purpose of this study was to explore the effects of the lavendula officinalis on depression in patients using citalopram.MethodsThis clinical trial study was performed in Hajar hospital, Shahrekord, Iran. In this study eighty patients randomly allocated into two groups (40 patients in each group). Patients who complained from depression were studied during a two-month double-blind study. In control group, patients were given 20 mg citalopram twice daily plus placebo and case group were treated with 5 g arial part of dried Lavendula officinalis and citaloperam (20 mg, twice per day). After 4 and 8 weeks, patients were followed for evaluations of their depression and complications. Depression severity was scored using standard Hamilton’s depression questionnaire. Data were analyzed using Chi square and Paired-t test.ResultsAfter 1 month treatment, mean depression score in case and control groups were 15.2 ± 3.6 and 17.5 ± 3.5, respectively (P < 0.05). After 2 months the mean score of depression in case and control groups was 14.8 ± 4 and 16.8 ± 4.6, respectively (P < 0.01). The most common side effects in two groups were confusion and dry mouth, which were not significantly different between two groups.ConclusionLavendula officinalis has a positive effect on depressed patients and may be useful to decrease the severity of depression in patients using other antidepressants.

Steroids and control of post-tonsillectomy pain

1993 ◽  
Vol 107 (7) ◽  
pp. 605-606 ◽  
Author(s):  
A. K. Tewary ◽  
H. R. Cable ◽  
G. S. Barr
Keyword(s):  
Surgical Technique ◽  
Visual Analog Scale ◽  
Blind Study ◽  
Double Blind Study ◽  
Appreciable Effect ◽  
Analog Scale ◽  
Double Blind ◽  
Post Operative Pain ◽  
And Control

A prospective, randomized, double-blind study to assess the effect of steroids on post-tonsillectomy pain was performed on 82 adults. The premedication, anaesthesia, surgical technique and post-operative analgesia were standardized. Pain was assessed on a visual analog scale. Steroids were found to have no appreciable effect on the amount of post-operative pain.

scholarly journals Primary hyperparathyroidism and metabolic risk factors, impact of parathyroidectomy and vitamin D supplementation, and results of a randomized double-blind study

2013 ◽  
Vol 169 (6) ◽  
pp. 795-804 ◽  
Author(s):  
Sophie Norenstedt ◽  
Ylva Pernow ◽  
Kerstin Brismar ◽  
Maria Sääf ◽  
Ayla Ekip ◽  
...  
Keyword(s):  
Vitamin D ◽  
Calcium Carbonate ◽  
Primary Hyperparathyroidism ◽  
Oral Treatment ◽  
Vitamin D Supplementation ◽  
University Hospital ◽  
Double Blind Study ◽  
Metabolic Disturbances ◽  
Double Blind ◽  
The Metabolic Syndrome

BackgroundVitamin D insufficiency may increase the risk for cardio metabolic disturbances in patients with primary hyperparathyroidism (PHPT).ObjectiveTo analyze the vitamin D status and indices of the metabolic syndrome in PHPT patients and the effect of vitamin D supplementation after parathyroid adenomectomy (PTX).Design and methodsDouble-blinded, randomized clinical trial (ClinicalTrials.gov Identifier: NCT00982722) performed at Karolinska University Hospital, Sweden, April 2008 to November 2011. One hundred and fifty consecutive patients with PHPT (119 women) were randomized after PTX, 75 to oral treatment with calcium carbonate 1000 mg daily and 75 to calcium carbonate 1000 mg and cholecalciferol 1600 IU daily over 12 months. Changes in metabolic profile and ambulatory blood pressure (BP) were analyzed. Main outcome measures were changes in metabolic factors, BP, and body composition.ResultsThe 25-hydroxyvitamin D (25-OH-D)-level was <50 nmol/l in 76% of the patients before PTX. After PTX, glucose, insulin, and IGF1 decreased, while the 25-OH-D and the IGF-binding protein 1 increased and remained unchanged at follow-up after study medication. One year of vitamin D supplementation resulted in lower parathyroid hormone (PTH) (40 (34–52) vs 49 (38–66) ng/l) and higher 25-OH-D (76 (65–93) vs 49 (40–62) nmol/l; P<0.05). Other laboratory parameters were stable compared with after PTX. Systolic BP decreased and total bone mineral content increased in both groups.ConclusionExcept for the lowering of the PTH level, no additive effect of vitamin D supplementation was seen. However, PTX proved effective in reducing insulin resistance.

scholarly journals A randomized controlled double-blind study of rotigotine on neuropsychiatric symptoms in de novo PD

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
A. Castrioto ◽  
◽  
S. Thobois ◽  
M. Anheim ◽  
J. L. Quesada ◽  
...  
Keyword(s):  
Trait Anxiety ◽  
Placebo Effect ◽  
Primary Outcome ◽  
De Novo ◽  
Neuropsychiatric Symptoms ◽  
Blind Study ◽  
Double Blind Study ◽  
Depression And Anxiety ◽  
Double Blind ◽  
Significant Difference

AbstractManagement of apathy, depression and anxiety in Parkinson’s disease (PD) represents a challenge. Dopamine agonists have been suggested to be effective. This multicenter, randomized (1:1), double-blind study assessed the 6-month effect of rotigotine versus placebo on apathy, depression and anxiety in de novo PD. The primary outcome was the change of apathy, measured with the LARS. The secondary outcomes were the change in depression and anxiety, measured with BDI-2 and STAI-trait and state. Forty-eight drug-naive PD patients were included. The primary outcome was not reached, with a surprisingly high placebo effect on apathy (60%). There was no significant difference in the change of depression at 6 months between rotigotine and placebo. Trait-anxiety was significantly improved by rotigotine compared to placebo (p = 0.04). Compared to placebo, low dose rotigotine significantly improved trait anxiety, but not apathy and depression. The major placebo effect on apathy points towards the importance of a multidisciplinary and tight follow-up in the management of neuropsychiatric symptoms.

scholarly journals Human Herpesviruses in Chronic Fatigue Syndrome

1999 ◽  
Vol 6 (2) ◽  
pp. 216-223 ◽  
Author(s):  
Howard L. Wallace ◽  
Benjamin Natelson ◽  
William Gause ◽  
John Hay
Keyword(s):  
Chronic Fatigue Syndrome ◽  
Mononuclear Cells ◽  
Chronic Fatigue ◽  
Double Blind Study ◽  
Double Blind ◽  
Peripheral Blood Mononuclear ◽  
Fatigue Syndrome ◽  
Axis I ◽  
And Control ◽  
Human Herpesviruses

ABSTRACT We have conducted a double-blind study to assess the possible involvement of the human herpesviruses (HHVs) HHV6, HHV7, Epstein-Barr virus (EBV), and cytomegalovirus in chronic fatigue syndrome (CFS) patients compared to age-, race-, and gender-matched controls. The CFS patient population was composed of rigorously screened civilian and Persian Gulf War veterans meeting the Centers for Disease Control and Prevention’s CFS case definition criteria. Healthy control civilian and veteran populations had no evidence of CFS or any other exclusionary medical or psychiatric condition. Patient peripheral blood mononuclear cells were analyzed by PCR for the presence of these HHVs. Using two-tailed Fisher’s exact test analyses, we were unable to ascertain any statistically significant differences between the CFS patient and control populations in terms of the detection of one or more of these viruses. This observation was upheld when the CFS populations were further stratified with regard to the presence or absence of major axis I psychopathology and patient self-reported gradual versus acute onset of disease. In tandem, we performed serological analyses of serum anti-EBV and anti-HHV6 antibody titers and found no significant differences between the CFS and control patients.

Intravenous Immunoglobulin Therapy for Prevention of Infection in High-Risk Premature Infants: Report of a Multicenter, Double-Blind Study

PEDIATRICS ◽  
1991 ◽  
Vol 88 (3) ◽  
pp. 437-443
Author(s):  
Jean-François Magny ◽  
Clothilde Bremard-Oury ◽  
Dominique Brault ◽  
Claudie Menguy ◽  
Marcel Voyer ◽  
...  
Keyword(s):  
Placebo Group ◽  
High Risk ◽  
Deleterious Effect ◽  
Controlled Trial ◽  
Immunoglobulin Therapy ◽  
Double Blind Study ◽  
Double Blind ◽  
Intravenous Immunoglobulin Therapy ◽  
Probable Infection ◽  
And Control

The effectiveness of intravenously administered immunoglobulin (Ig) therapy for prophylaxis of infection was evaluated in high-risk preterm infants. Two hundred thirty-five premature newborns were randomly assigned, in a double-blind controlled trial, to treatment and placebo groups. Thirty-five infants (29%) of the Ig group and 29 (25%) of the placebo group had one or more episodes of certain infection. Thirty infants (25%) of the Ig group and 18 (16%) of the placebo group had one or more episodes of probable infection. No significant differences were observed in the incidence of certain or probable infection in treated and control infants. Nevertheless, among the infants who had one or more certain or probable episodes of infection, more of them belonged to the Ig group than to the placebo group. The possible deleterious effect of the administration of large amounts of polyspecific Ig is discussed.

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