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.

Randomized double-blind prospective trial to evaluate the effects of sargramostim versus placebo in a moderate-dose fluorouracil, doxorubicin, and cyclophosphamide adjuvant chemotherapy program for stage II and III breast cancer.

1996 ◽  
Vol 14 (11) ◽  
pp. 2976-2983 ◽  
Author(s):  
S E Jones ◽  
M W Schottstaedt ◽  
L A Duncan ◽  
R L Kirby ◽  
R H Good ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Dose Intensity ◽  
Stage Ii ◽  
Severe Neutropenia ◽  
Controlled Study ◽  
Moderate Dose ◽  
Double Blind ◽  
Long Term Outcome ◽  
Gm Csf

PURPOSE To determine the effects of sargramostim (recombinant human granulocyte-macrophage colony-stimulating factor [rhu GM-CSF]) on the incidence, duration, and complications of myelosuppression after moderate-dose fluorouracil, doxorubicin, cyclophosphamide (FAC) adjuvant chemotherapy in patients with node-positive breast cancer. PATIENTS AND METHODS In this randomized, double-blind, placebo-controlled study, 142 women with stage II and III breast cancer were to receive four 21-day cycles of chemotherapy that consisted of fluorouracil 600 mg/ m2 intravenously (IV), doxorubicin 60 mg/m2 IV, and cyclophosphamide 750 mg/m2 IV on day 1, followed by placebo or GM-CSF 250 micrograms/m2/d daily subcutaneously (SC) on days 3 through 15. All patients received prophylactic ciprofloxacin by mouth when the absolute neutrophil count (ANC) was less than 1,000/microL. RESULTS Eighty-six percent of GM-CSF patients (n = 62) and 96% of placebo patients (n = 69) completed four assessable cycles of treatment on study. Overall, the median duration of severe neutropenia (ANC < 500/microL) was 2.8 days with GM-CSF and 6.8 days with placebo (P < .001); the duration of ANC less than 1,000/microL was 6.0 versus 9.1 days, respectively (P < .001). Hospitalizations for febrile neutropenia were uncommon in either group: GM-CSF, six; placebo, eight. The only other difference in hematologic toxicity was grade 3/4 thrombocytopenia observed with greater frequency in GM-CSF patients than placebo patients in cycles 3 and 4. GM-CSF increased mean the FAC dose-intensity among patients who completed two or more cycles (P < .001). GM-CSF was generally well tolerated and associated with more injection-site reactions, but less mucositis than placebo. There were no deaths on study. CONCLUSION GM-CSF significantly enhanced ANC recovery after FAC chemotherapy; it decreased the incidence and duration of associated neutropenia and moderately increased the dose-intensity of adjuvant chemotherapy. Whether these effects will ultimately translate into improved long-term outcome remains to be determined.

Prophylactic Topical Treatment for EGFR Inhibitor-Induced Papulopustular Rash: A Randomized Clinical Trial

Dermatology ◽  
2020 ◽  
pp. 1-7
Author(s):  
Iris Amitay-Laish ◽  
Hadas Prag-Naveh ◽  
Ayelet Ollech ◽  
Batya Davidovici ◽  
Yael Anne Leshem ◽  
...  
Keyword(s):  
Topical Treatment ◽  
Protocol Analysis ◽  
Controlled Trial ◽  
Growth Factor Receptor ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Epidermal Growth ◽  
The Common ◽  
Grade 3 ◽  
To Receive

<b><i>Background:</i></b> The incidence of epidermal growth factor receptor inhibitor (EGFRI)-induced papulopustular rash is 60–85%. <b><i>Objective:</i></b> To investigate prophylactic topical treatment for EGFRI-induced rash. <b><i>Methods:</i></b> A single-center, randomized, double-blind, placebo-controlled trial. Adult cancer patients initiating treatment with EGFRIs were randomized to receive facial topical treatment with chloramphenicol 3% + prednisolone 0.5% (CHL-PRED) ointment, chloramphenicol 3% (CHL) ointment, or aqua cream (AQUA). The primary end points were the incidence of ≥grade 3 rash using the Common Terminology Criteria for Adverse Events (CTCAE), on days 14 and 30. A subanalysis was conducted for incidence of a protocol-specified significant rash, defined as ≥10 facial papulopustular lesions. <b><i>Results:</i></b> The per-protocol analysis on day 14 included 69 patients, who received CHL-PRED (21), CHL (23), or AQUA (25). The incidence of CTCAE ≥grade 3 rash was not statistically significant between arms; however, the incidence of the protocol-specified significant rash was: CHL-PRED 14%, CHL 39%, and AQUA 48% (<i>p</i> = 0.03, CHL-PRED vs. AQUA). At 30 days, the CTCAE ≥grade 3 incidence was similar, but the incidences of protocol-specified significant rash were 6%, 16%, and 43% (<i>p</i> = 0.03, CHL-PRED vs. AQUA). No significant differences were found between CHL and CHL-PRED and between CHL and AQUA. <b><i>Conclusions:</i></b> Prophylactic topical CHL-PRED was efficacious when compared to AQUA, in the treatment of EGFRI-induced facial papulopustular rash.

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).

scholarly journals Effect of Melatonin on Cognitive Function and Sleep in relation to Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Melissa Voigt Hansen ◽  
Michael Tvilling Madsen ◽  
Lærke Toftegård Andersen ◽  
Ida Hageman ◽  
Lars Simon Rasmussen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Placebo Group ◽  
Cognitive Function ◽  
Cognitive Dysfunction ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Sleep Efficiency ◽  
Mean Difference ◽  
Double Blind ◽  
Double Blind Placebo

Background.Sleep disturbances and cognitive dysfunction are common in patients with breast cancer. Disturbed sleep leads to poor cognitive performance and exogenous melatonin may improve sleep and attenuate cognitive dysfunction. We hypothesized that melatonin would improve sleep and cognitive function after surgery.Methods.This study reports secondary endpoints from a randomized, double-blind, placebo-controlled trial. Women, 30–75 years, were randomized to 6mg oral melatonin/placebo for 3 months. We assessed postoperative cognitive dysfunction (POCD) with a neuropsychological test battery, sleep with a diary, and sleep quality with VAS.Results. 54 patients were randomized to melatonin (n=28) or placebo (n=26); 11 withdrew (10 placebo, 1 melatonin,P=0.002). The incidence of POCD was 0% (0/20) [95% CI 0.0%; 16.8%] in the placebo group and 0% (0/26) [95% CI 0.0%; 13.2%] in the melatonin group 2 weeks postoperatively (P=1.00) and 6.3% (1/16) [95% CI 0.0%; 30.2%] in the placebo group and 0% (0/26) [95% CI 0.0%; 13.2%] in the melatonin group 12 weeks postoperatively (P=0.38). Sleep efficiency was significantly greater in the melatonin group; mean difference was 4.28% [95% CI 0.57; 7.82] (P=0.02). The total sleep period was significantly longer in the melatonin group; mean difference was 37.0 min [95% CI 3.6; 69.7] (P=0.03).Conclusion.Melatonin increased sleep efficiency and total sleep time but did not affect cognitive function. The dropout rate was significantly lower in the melatonin group. This trial is registered with Clinicaltrials.govNCT01355523.

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.

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