Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Recombinant Human Intestinal Trefoil Factor Oral Spray for Prevention of Oral Mucositis in Patients With Colorectal Cancer Who Are Receiving Fluorouracil-Based Chemotherapy

2009 ◽  
Vol 27 (26) ◽  
pp. 4333-4338 ◽  
Author(s):  
Douglas E. Peterson ◽  
Nicholas P. Barker ◽  
Lilia I. Akhmadullina ◽  
Irina Rodionova ◽  
Nailya Z. Sherman ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Oral Mucositis ◽  
Low Dose ◽  
Area Under The Curve ◽  
Controlled Study ◽  
High Dose ◽  
Trefoil Factor ◽  
Intestinal Trefoil Factor ◽  
Double Blind ◽  
Who Grade

Purpose This study evaluated the safety and efficacy of recombinant human intestinal trefoil factor (rhITF) administered as topical oral spray for prevention and treatment of chemotherapy-induced oral mucositis (OM). Patients and Methods Ninety-nine patients with colorectal cancer who had moderate to severe OM (WHO grade ≥ 2) in the first cycle of chemotherapy were randomly assigned to receive either placebo, rhITF 10 mg/mL (ie, low dose), or rhITF 80 mg/mL (ie, high dose) by oral spray (300 μL, eight times each day) for 14 consecutive days in the second chemotherapy cycle. Patients were assessed on days 1, 3, 5, 7, 10, 12, 14, and 21 (± 2 days for the last assessment) for safety and for OM incidence and severity. Results Treatment of patients at high risk for developing OM with low- or high-dose rhITF significantly reduced the amount of incidence (75% to 81%; low-dose rhITF P < .001; high-dose rhITF P = .002). Frequencies of WHO grade ≥ 2 OM in the placebo, low-dose rhITF, and high-dose rhITF groups were 48.5%, 9.1%, and 12.1%, respectively. Assessment of the area under the curve revealed statistically significant reductions in OM severity in the rhITF-treated groups versus placebo. Only a minority of patients (6.1%) reported treatment-emergent adverse events (TEAEs), all of which were mild to moderate in intensity and resolved without sequelae. The incidence of TEAEs was not significantly different among treatment groups. Conclusion rhITF oral spray formulation was safe and effective when used for the reduction of chemotherapy-associated OM in patients with colorectal cancer. Patients exhibited high compliance in dosing administration. Future clinical study is planned to develop this drug for use in OM management in patients with cancer.

scholarly journals Co-Administration of Iron and a Bioavailable Curcumin Supplement Increases Serum BDNF Levels in Healthy Adults

Antioxidants ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. 645 ◽  
Author(s):  
Helena Tiekou Lorinczova ◽  
Owen Fitzsimons ◽  
Leah Mursaleen ◽  
Derek Renshaw ◽  
Gulshanara Begum ◽  
...  
Keyword(s):  
Iron Supplementation ◽  
Energy Homeostasis ◽  
Low Dose ◽  
Controlled Study ◽  
High Dose ◽  
Double Blind ◽  
Treatment Groups ◽  
Novel Approach ◽  
First Time ◽  
Serum Bdnf

Brain-derived neurotrophic factor (BDNF) is key for the maintenance of normal neuronal function and energy homeostasis and has been suggested to improve cognitive function, including learning and memory. Iron and the antioxidant curcumin have been shown to influence BDNF homeostasis. This 6-week, double blind, randomized, placebo-controlled study examined the effects of oral iron supplementation at low (18 mg) and high (65 mg) ferrous (FS) iron dosages, compared to a combination of these iron doses with a bioavailable formulated form of curcumin (HydroCurcTM; 500 mg) on BDNF levels in a healthy adult cohort of 155 male (26.42 years ± 0.55) and female (25.82 years ± 0.54) participants. Participants were randomly allocated to five different treatment groups: both iron and curcumin placebo (FS0+Plac), low dose iron and curcumin placebo (FS18+Plac), low dose iron and curcumin (FS18+Curc), high dose iron and curcumin placebo (FS65+Plac) and high dose iron and curcumin (FS65+Curc). Results showed a significant increase in BDNF over time (26%) in the FS18+Curc group (p = 0.024), and at end-point between FS18+Curc and FS18+Plac groups (35%, p = 0.042), demonstrating for the first time that the combination with curcumin, rather than iron supplementation alone, results in increased serum BDNF. The addition of curcumin to iron supplementation may therefore provide a novel approach to further enhance the benefits associated with increased BDNF levels.

Weekly high-dose leucovorin versus low-dose leucovorin combined with fluorouracil in advanced colorectal cancer: results of a randomized multicenter trial. Study Group for Palliative Treatment of Metastatic Colorectal Cancer Study Protocol 1.

1996 ◽  
Vol 14 (8) ◽  
pp. 2274-2279 ◽  
Author(s):  
E Jäger ◽  
M Heike ◽  
H Bernhard ◽  
O Klein ◽  
G Bernhard ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Side Effects ◽  
Metastatic Colorectal Cancer ◽  
Low Dose ◽  
Multicenter Trial ◽  
World Health ◽  
High Dose ◽  
Who Grade ◽  
Group A ◽  
Group B

PURPOSE To determine the most effective dose of leucovorin (folinic acid [FA]) within a weekly bolus fluorouracil (FU) schedule, we conducted a randomized multicenter trial to compare therapeutic effects and toxicity of high-dose FA versus low-dose FA combined with FU at equal doses in both treatment groups. PATIENTS AND METHODS Patients with measurable inoperable or metastatic colorectal cancer were randomized to receive weekly FU 500 mg/m2 by intravenous (IV) bolus combined with high-dose FA 500 mg/m2 (group A) or low-dose FA 20 mg/m2 (group B) by 2-hour infusion. RESULTS Of 291 assessable patients (group A, n = 148; group B, n = 143), we observed, in group A, complete response (CR)/partial response (PR) in 32 (21.6%), no change (NC) in 64 (43.2%), and progressive disease (PD) in 52 (35.1%); and in group B, CR/PR in 25 (17.5%), NC in 63 (44.1%), and PD in 55 (38.5%). The median response duration was 24.8 weeks in group A and 23.1 weeks in group B. Median progression-free intervals were 29.3 weeks (group A) and 30 weeks (group B). The median survival time was 55.1 weeks in group A and 54.1 weeks in group B. Overall toxicity was moderate. Mild nausea and vomiting, and stomatitis were common side effects in both groups. The incidence of World Health Organization (WHO) grade III/IV diarrhea was significantly higher in group A (40 v 23 patients). Severe side effects were observed only in a minority of patients in both arms. WHO grade IV diarrhea was observed in seven patients: four in group A and three in group B. The rate of toxicity-related adjustments of dose and schedule was comparable in both groups. CONCLUSION High-dose FA/FU is not superior to low-dose FA/FU within a weekly treatment schedule. Response rates and survival were comparable in both treatment arms. Treatment-related toxicity was higher in group A (high-dose FA). Therefore, low-dose FA combined with weekly FU may be considered the preferred treatment for metastatic colorectal cancer.

SM03, an anti-human CD22 monoclonal antibody, for active rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled study

Rheumatology ◽  
2021 ◽  
Author(s):  
Jing Li ◽  
Mengtao Li ◽  
Di Wu ◽  
Jiaxin Zhou ◽  
Shui-on Leung ◽  
...  
Keyword(s):  
B Cell ◽  
Phase Ii ◽  
Dose Group ◽  
Low Dose ◽  
Response Rate ◽  
Controlled Study ◽  
High Dose ◽  
Double Blind ◽  
Acr20 Response ◽  
Acr20 Response Rate

Abstract Objective SM03, a novel chimaeric mAb specific to B cell-restricted antigen CD22, has been developed to treat RA and other B-cell-related diseases. This 24-week phase II randomized, double-blind, multi-dose, placebo-controlled study aimed to evaluate the efficacy and safety of SM03 in moderately-to-severely active RA patients in China. Methods One hundred and fifty-six patients on background MTX were randomized in a 1:1:1 ratio to receive a cumulative dose of 3600 mg (high dose, 600 mg × 6 infusions at weeks 0, 2, 4, 12, 14 and 16) or 2400 mg SM03 (low dose, 600 mg × 4 infusions at weeks 0, 2, 12 and 14) or the placebo. The primary outcome was the 24-week ACR 20% improvement criteria (ACR20) response rate. Safety was also assessed. Results The 24-week ACR20 response rate was significantly higher with high- (65.3%, P = 0.002) and low-dose SM03 (56.9%, P = 0.024) than with placebo (34.0%), but comparable between the high- and low-dose group. The rate of adverse events was not statistically different among the high-dose group (35.3%), the low-dose group (51.9%) and the placebo group (34.6%). Thirteen (12.6%) patients receiving SM03 reported treatment-emergent infections, including 3.9% patients in the high-dose group. No patients reported severe treatment-emergent infections or malignancies. Conclusions In active RA Chinese patients receiving background MTX, SM03 at a cumulative dose of both 2400 mg and 3600 mg is efficacious and well-tolerated throughout the 24 weeks of treatment. Moreover, SM03 has demonstrated a good safety profile. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT04192617.

High-dose adenosine infusion provokes oscillations of chest pain without correlation to opioid modulation: A double-blind controlled study

2004 ◽  
Vol 5 (9) ◽  
pp. 469-475 ◽  
Author(s):  
Bita Sadigh-Lindell ◽  
Christer Sylvén ◽  
Margareta Berglund ◽  
Björn E. Eriksson
Keyword(s):  
Chest Pain ◽  
Adenosine Infusion ◽  
Controlled Study ◽  
High Dose ◽  
Double Blind

Analysis of acute naproxen administration on memory in young adults: A randomized, double-blind, placebo-controlled study

2017 ◽  
Vol 31 (10) ◽  
pp. 1374-1376
Author(s):  
Jack H Wilson ◽  
Amy H Criss ◽  
Sean A Spangler ◽  
Katherine Walukevich ◽  
Sandra Hewett
Keyword(s):  
Young Adults ◽  
Healthy Adult ◽  
Adult Population ◽  
Critical Role ◽  
Random Order ◽  
Controlled Study ◽  
High Dose ◽  
Short Term ◽  
Double Blind ◽  
Inflammatory Drugs

Nonsteroidal anti-inflammatory drugs work by non-selectively inhibiting cyclooxygenase enzymes. Evidence indicates that metabolites of the cyclooxygenase pathway play a critical role in the process of learning and memory. We evaluated whether acute naproxen treatment impairs short-term working memory, episodic memory, or semantic memory in a young, healthy adult population. Participants received a single dose of placebo or naproxen (750 mg) in random order separated by 7–10 days. Two hours following administration, participants completed five memory tasks. The administration of acute high-dose naproxen had no effect on memory in healthy young adults.

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