Phase III placebo-controlled trial of capsaicin cream in the management of surgical neuropathic pain in cancer patients.

1997 ◽  
Vol 15 (8) ◽  
pp. 2974-2980 ◽  
Author(s):  
N Ellison ◽  
C L Loprinzi ◽  
J Kugler ◽  
A K Hatfield ◽  
A Miser ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Controlled Trial ◽  
Phase Iii ◽  
Painful Site ◽  
Average Pain ◽  
Skin Redness ◽  
Topical Capsaicin ◽  
Chili Peppers ◽  
Placebo Cream

PURPOSE A minority of cancer survivors develops long-term postsurgical neuropathic pain. Based on evidence that capsaicin, the pungent ingredient in hot chili peppers, might be useful for treating neuropathic pain, we developed the present clinical trial. PATIENTS AND METHODS Ninety-nine assessable patients with postsurgical neuropathic pain were entered onto this study. After stratification, patients were to receive 8 weeks of a 0.075% capsaicin cream followed by 8 weeks of an identical-appearing placebo cream, or vice versa. A capsaicin/placebo cream was to be applied to the painful site four times daily. Treatment evaluation was performed by patient-completed weekly questionnaires. RESULTS During the first 8-week study period, the capsaicin-cream arm was associated with substantially more skin burning, skin redness, and coughing (P < .0001 for each). Nonetheless, treatment was stopped for patient refusal or toxicity just as often while patients were receiving the placebo as compared with the capsaicin. The capsaicin cream arm had substantially more pain relief (P = .01) after the first 8 weeks, with an average pain reduction of 53% versus 17%. On completion of the 16-week study period, patients were asked which treatment period was most beneficial. Of the responding patients, 60% chose the capsaicin arm, 18% chose the placebo arm, and 22% chose neither (P = .001). CONCLUSION A topical capsaicin cream decreases postsurgical neuropathic pain and, despite some toxicities, is preferred by patients over a placebo by a three-to-one margin among those expressing a preference.

Phase III, placebo-controlled trial (SUCCEED) evaluating ridaforolimus as maintenance therapy in advanced sarcoma patients following clinical benefit from prior standard cytotoxic chemotherapy: Long-term (≥ 24 months) overall survival results.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 10010-10010 ◽  
Author(s):  
Jean-Yves Blay ◽  
Sant P. Chawla ◽  
Isabelle Ray-Coquard ◽  
Axel Le Cesne ◽  
Arthur P. Staddon ◽  
...  
Keyword(s):  
Overall Survival ◽  
Maintenance Therapy ◽  
Controlled Trial ◽  
Mammalian Target Of Rapamycin ◽  
Progression Free Survival ◽  
Mtor Inhibitors ◽  
Phase Iii ◽  
Clinical Activity ◽  
Prior Chemotherapy

10010 Background: The mammalian target of rapamycin (mTOR) regulates cell growth and proliferation and is abnormally activated in many sarcomas. Ridaforolimus, an oral mTOR inhibitor, demonstrated clinical activity in previous nonrandomized trials in advanced sarcomas following failure of prior chemotherapy. Methods: An international, multicenter, placebo-controlled, phase 3 trial was conducted to evaluate maintenance therapy with ridaforolimus in patients with metastatic soft-tissue or bone sarcomas who achieved disease control from prior chemotherapy. Patients were randomized (1:1) to receive oral ridaforolimus (40 mg) or placebo once daily for 5 days each week. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS) and safety and tolerability. For OS, patients were to be followed at 3-month intervals for at least 24 months and up to 60 months after randomization. Results: 702 of 711 randomized patients received treatment. At the time of the data cutoff for OS (386 deaths), patients in the study population had been followed for at least 15 months. Median OS was 93.3 weeks with ridaforolimus vs 83.4 weeks with placebo (hazard ratio [HR]=0.88; 95% confidence interval [CI]: 0.72, 1.08; P=0.23). Ridaforolimus significantly improved PFS vs placebo (HR=0.72; 95% CI: 0.61, 0.85; P=0.0001; median PFS: 17.7 weeks vs 14.6 weeks); PFS improved across all prespecified baseline characteristics. As expected from the class of mTOR inhibitors, the most common adverse events with ridaforolimus were stomatitis, thrombocytopenia, noninfectious pneumonitis, hypertriglyceridemia, hyperglycemia, infections, and rash. Conclusions: Oral ridaforolimus was generally well-tolerated and significantly improved PFS in metastatic sarcoma patients with benefit from prior chemotherapy, offering an effective treatment alternative to surveillance alone. Results of a long-term OS analysis (prespecified to occur at 67% mortality, 24 months minimum follow-up) in the intent-to-treat population will be available in early 2012.

PRODIGE: A phase III randomized placebo-controlled trial of thromboprophylaxis using dalteparin low molecular weight heparin (LMWH) in patients with newly diagnosed malignant glioma

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2011-2011 ◽  
Author(s):  
J. R. Perry ◽  
L. Rogers ◽  
N. Laperriere ◽  
J. Julian ◽  
W. Geerts ◽  
...  
Keyword(s):  
Malignant Glioma ◽  
Administrative Support ◽  
Controlled Trial ◽  
Steering Committee ◽  
Research Network ◽  
Phase Iii ◽  
Study Medication ◽  
Newly Diagnosed

2011 Background: Venous thromboembolism (VTE) occurs in 20–30% of patients with malignant glioma per year of survival. We have conducted an RCT testing the efficacy and safety of long-term dalteparin for the prevention of VTE in newly diagnosed malignant glioma. Methods: Adults with newly diagnosed malignant glioma were randomized to receive dalteparin 5,000 anti-Xa units or placebo, both subcutaneously daily for 6 months starting within the first month after surgery. Patients were allowed to continue study medication for up to 12 months. Because of the poor prognosis of malignant glioma it was determined apriori that the primary outcome was 6-month VTE-free survival. In order to detect a 60% VTE hazard reduction with LMWH with 80% power, 512 patients were required. Results: Recruitment began October 2002 and was closed in May 2006 because of expiration of study medication and no further re-supply. Of the 563 patients screened at 15 centers, 174 were excluded. Of the 389 eligible patients approached for consent, 186 were randomized: 99 to LMWH, 87 to placebo. Twenty-one patients developed objectively confirmed VTE during the first 6 months: 9 on LMWH and 12 on placebo (11% and 17% respectively; HR=0.7, 95% CI: 0.37–1.5, p=0.3). Over the 12 months there were 5 (5.1%) major bleeds with LMWH and 1 (1.2%) with placebo (HR=4.0, 95%CI: 0.5–34, p=0.2). All major bleeds were intracranial. Twelve-month mortality was 48% for LMWH and 45% for placebo (HR=1.2, 95%CI: 0.7–1.9, p=0.5). Conclusions: Although there was a trend in favor of the LMWH reducing VTE this was not statistically significant, likely as a result of low power. There was also a trend for increased intracranial bleeding with LMWH. Our study confirms the high incidence of thromboembolism in these patients; however, the role of long-term anticoagulant thromboprophylaxis remains unclear. Supported in part by a grant in aid from Pfizer Inc. and the Ontario Cancer Research Network. The PRODIGE steering committee thanks Terri Finch for superb administrative support. Pfizer

scholarly journals A Functional Threshold for Long-Term Use of Hand and Arm Function Can Be Determined: Predictions From a Computational Model and Supporting Data From the Extremity Constraint-Induced Therapy Evaluation (EXCITE) Trial

2009 ◽  
Vol 89 (12) ◽  
pp. 1327-1336 ◽  
Author(s):  
Nicolas Schweighofer ◽  
Cheol E. Han ◽  
Steven L. Wolf ◽  
Michael A. Arbib ◽  
Carolee J. Winstein
Keyword(s):  
Controlled Trial ◽  
Hand Function ◽  
Cost Effective ◽  
Phase Iii ◽  
Future Research ◽  
Therapy Evaluation ◽  
Effective Interventions ◽  
Term Change ◽  
Number Of Patients

Background Although spontaneous use of the more-affected arm and hand after stroke is an important determinant of participation and quality of life, a number of patients exhibit decreases in use following rehabilitative therapy. A previous neurocomputational model predicted that if the dose of therapy is sufficient to bring performance above a certain threshold, training can be stopped. Objective The aim of this study was to test the hypothesis that there exists a threshold for function of the paretic arm and hand after therapy. If function is above this threshold, spontaneous use will increase in the months following therapy. In contrast, if function is below this threshold, spontaneous use will decrease. Methods New computer simulations are presented showing that changes in arm use following therapy depend on a performance threshold. This prediction was tested by reanalyzing the data from the Extremity Constraint-Induced Therapy Evaluation (EXCITE) trial, a phase III randomized controlled trial in which participants received constraint-induced movement therapy for 2 weeks and were tested both 1 week and 1 year after therapy. Results The results demonstrate that arm and hand function measured immediately after therapy predicts, on average, the long-term change of arm use. Above a functional threshold, use improves. Below this threshold, use decreases. Limitations The reanalysis of the EXCITE trial data provides a “group” threshold above which a majority of patients, but not all, improve spontaneously. A goal of future research is to provide the means to assess when patients reach their individual threshold. Conclusion Understanding of the causal and nonlinear relationship between limb function and daily use is important for the future development of cost-effective interventions and prevention of “rehabilitation in vain.”

scholarly journals Randomized trial of azithromycin to eradicate Ureaplasma respiratory colonization in preterm infants: 2-year outcomes

2021 ◽  
Author(s):  
Rose M. Viscardi ◽  
Michael L. Terrin ◽  
Laurence S. Magder ◽  
Natalie L. Davis ◽  
Susan J. Dulkerian ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Strong Evidence ◽  
Controlled Trial ◽  
Tracheal Aspirate ◽  
Phase Iii ◽  
Respiratory Morbidity ◽  
List Type ◽  
Neurodevelopmental Outcomes ◽  
Neurodevelopmental Impairment

Abstract Background To assess the potential impact of azithromycin treatment in the first week following birth on 2-year outcomes in preterm infants with and without Ureaplasma respiratory colonization who participated in a double-blind, placebo-controlled randomized controlled trial. Methods Respiratory morbidity was assessed at NICU discharge and at 6, 12, and 22–26 months corrected age using pulmonary questionnaires. Comprehensive neurodevelopmental assessments were completed between 22 and 26 months corrected age. The primary and secondary composite outcomes were death or severe respiratory morbidity and death or moderate–severe neurodevelopmental impairment, respectively, at 22–26 months corrected age. Results One hundred and twenty-one randomized participants (azithromycin, N = 60; placebo, N = 61) were included in the intent-to-treat analysis. There were no significant differences in death or serious respiratory morbidity (34.8 vs 30.4%, p = 0.67) or death or moderate–severe neurodevelopmental impairment (47 vs 33%, p = 0.11) between the azithromycin and placebo groups. Among all trial participants, tracheal aspirate Ureaplasma-positive infants experienced a higher frequency of death or serious respiratory morbidity at 22–26 months corrected age (58%) than tracheal aspirate Ureaplasma-negative infants (34%) or non-intubated infants (21%) (p = 0.028). Conclusions We did not observe strong evidence of a difference in long-term pulmonary and neurodevelopment outcomes in preterm infants treated with azithromycin in the first week of life compared to placebo. Impact No strong evidence of a difference in long-term pulmonary and neurodevelopment outcomes was identified at 22–26 months corrected age in infants treated with azithromycin in the first week of life compared to placebo. The RCT is the first study of 2-year pulmonary and neurodevelopmental outcomes of azithromycin treatment in ELGANs. Provides evidence that ELGANs with lower respiratory tract Ureaplasma have the most frequent serious respiratory morbidity in the first 2 years of life, suggesting that a Phase III trial of azithromycin to prevent BPD targeting this population is warranted.

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