A Randomized, Placebo-Controlled Study to Evaluate the Effect of Bio-Enhanced Turmeric Formulation on Radiation-Induced Oral Mucositis

ORL ◽  
2021 ◽  
pp. 1-11
Author(s):  
Tej Prakash Soni ◽  
Anil Kumar Gupta ◽  
Lalit Mohan Sharma ◽  
Harish Singhal ◽  
Shantanu Sharma ◽  
...  
Keyword(s):  
Weight Loss ◽  
Oral Cancer ◽  
Oral Mucositis ◽  
Controlled Trial ◽  
Controlled Study ◽  
High Dose ◽  
Oral Pain ◽  
Oral Cancer Patients ◽  
Grade 3 ◽  
The Impact

<b><i>Introduction:</i></b> Oral mucositis is the most common toxicity of chemoradiotherapy treatment of head and neck cancers. The present study was performed to evaluate the effect of a researched turmeric formulation on oral mucositis in patients receiving chemoradiotherapy for oral cancer. <b><i>Methods:</i></b> This randomized double-blinded placebo-controlled trial included 60 patients with oral cancer who had undergone radical surgery. Patients were equally randomized into 3 arms. Bio-enhanced turmeric formulation (BTF) capsules (low dose [1 g/day] or high dose [1.5 g/day]) or placebo was administered daily for 6 weeks with concurrent chemoradiotherapy. Study endpoints included the impact of the treatment on chemoradiotherapy-induced oral mucositis along with dysphagia, oral pain, dermatitis, and weight loss. <b><i>Results:</i></b> The incidence of grade 3 toxicity of oral mucositis, oral pain, dysphagia, and dermatitis was significantly lower in patients who received BTF than placebo. Twenty-five and 20% patients in BTF 1 g/day (<i>p</i> = 0.011) and 1.5 g/day (<i>p</i> = 0.004) arms, respectively, developed grade 3 oral mucositis compared to 65% patients in the placebo arm. Thirty-five and 30% patients in BTF 1 g/day (<i>p</i> = 0.027) and 1.5 g/day (<i>p</i> = 0.011) arms, respectively, developed grade 3 oral pain compared to 70% patients in the placebo arm. Twenty-five and 20% patients in BTF 1 g/day (<i>p</i> = 0.025) and 1.5 g/day (<i>p</i> = 0.010) arms, respectively, developed grade 3 dysphagia compared to 60% patients in the placebo arm. Ten and 5% patients in BTF 1 g/day (<i>p</i> = 0.114) and 1.5 g/day (<i>p</i> = 0.037) arms. respectively, developed grade 3 dermatitis compared to 30% patients in the placebo arm. Patients under BTF supplementation experienced significantly less weight loss and greater compliance with treatment than placebo. <b><i>Conclusion:</i></b> BTF (BCM-95®) can significantly reduce chemoradiotherapy-induced severe oral mucositis, dysphagia, oral pain, and dermatitis in oral cancer patients. <b><i>Trial Registration:</i></b> Clinical Trials Registry, India (Registration No. CTRI) (CTRI/2015/12/006413 dated December 4, 2015).

Impact of oral mucositis on outcomes of multiple myeloma patients treated with high-dose melphalan conditioning and autologous stem cell transplantation (ASCT).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 7037-7037
Author(s):  
Graziella Chagas Jaguar ◽  
Gustavo Henrique Rodrigues ◽  
Andre Guollo ◽  
Vanessa Oliveira Camandoni ◽  
Leila Maria Magalhães Pessoa Melo ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Parenteral Nutrition ◽  
Clinical Outcomes ◽  
Oral Mucositis ◽  
Conditioning Regimen ◽  
High Dose ◽  
Pharmacokinetic Studies ◽  
Oral Pain ◽  
Grade 3 ◽  
High Dose Melphalan

7037 Background: High-dose melphalan is the standard conditioning regimen for patients with multiple myeloma (MM) undergoing ASCT. However, this therapy is commonly associated with severe oral mucositis (OM). Low-level laser therapy (LLLT) has been reported as an effective method in preventing this complication. The aim of this study was to define the potential impact of OM on outcomes in patients with MM undergoing ASCT and receiving preventive LLLT. Methods: We describe a retrospective cohort of 79 consecutive patients with MM who received high-dose melphalan conditioning. All patients received prophylactic LLLT application performed daily from the beginning of the conditioning regimen up to day +2. The patients continued receiving LLLT in case of OM grade ≥ 2 until complete remission of the lesions. OM severity was assessed daily using WHO scale from the beginning of conditioning until hospital discharge. We examined the relationship between worst OM grade and clinical outcomes, including days with oral pain, days of total parenteral nutrition, days of LLLT and days with neutropenic fever. Results: Of 79 patients, 55 (69.62%) experienced OM grade 0-1, 16 (20.25%) experienced OM grade 2, 7 (8.86%) grade 3 and 1 (1.26%) grade 4. Patients with OM grade 0-2 had statistically fewer days of oral pain compared with grade 3-4 (0.88 and 6.25 days, respectively, p = 0.0001). The worst OM grade was also significantly (p < 0.05) associated with days of narcotic therapy and length of LLLT. Severe OM was not associated with febrile days or the use of parenteral nutrition. Conclusions: Severe OM is associated with worse clinical outcomes. In this transplantation setting, severe OM was not common as previously reported in literature, probably due to LLLT. Controlled randomized trials should be performed to confirm the real benefit of LLLT in this scenario as well as the pharmacogenomics and pharmacokinetic studies to better understand interpatient variability of melphalan exposure and toxicity.

scholarly journals Pterostilbene on Metabolic Parameters: A Randomized, Double-Blind, and Placebo-Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Daniel M. Riche ◽  
Krista D. Riche ◽  
Chad T. Blackshear ◽  
Corey L. McEwen ◽  
Justin J. Sherman ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Weight Loss ◽  
Total Cholesterol ◽  
Mixed Models ◽  
Controlled Trial ◽  
Metabolic Parameters ◽  
Controlled Study ◽  
High Dose ◽  
Double Blind ◽  
Over Time

Introduction. The purpose of this trial was to evaluate the effect of pterostilbene on metabolic parameters.Methods. A prospective, randomized, double-blind, and placebo-controlled study that enrolled 80 patients with a total cholesterol ≥200 mg/dL and/orLDL≥100 mg/dL. Subjects were divided into four groups: (1) pterostilbene 125 mg twice daily; (2) pterostilbene 50 mg twice daily; (3) pterostilbene 50 mg + grape extract (GE) 100 mg twice daily; (4) matching placebo twice daily for 6–8 weeks. Endpoints included lipids, blood pressure, and weight. Linear mixed models were used to examine and compare changes in parameters over time. Models were adjusted for age, gender, and race.Results. LDL increased with pterostilbene monotherapy (17.1 mg/dL;P=0.001) which was not seen with GE combination (P=0.47). Presence of a baseline cholesterol medication appeared to attenuate LDL effects. Both systolic (−7.8 mmHg;P<0.01) and diastolic blood pressure (−7.3 mmHg;P<0.001) were reduced with high dose pterostilbene. Patients not on cholesterol medication (n=51) exhibited minor weight loss with pterostilbene (−0.62 kg/m2;P=0.012).Conclusion. Pterostilbene increases LDL and reduces blood pressure in adults. This trial is registered with Clinicaltrials.govNCT01267227.

scholarly journals High Expression of KLF10 Is Associated with Favorable Survival in Patients with Oral Squamous Cell Carcinoma

Medicina ◽  
2020 ◽  
Vol 57 (1) ◽  
pp. 17
Author(s):  
Chung-Min Yeh ◽  
Yi-Ju Lee ◽  
Po-Yun Ko ◽  
Yueh-Min Lin ◽  
Wen-Wei Sung
Keyword(s):  
Survival Rate ◽  
Oral Cancer ◽  
Cancer Patients ◽  
Protective Factor ◽  
Female Gender ◽  
Vital Role ◽  
Cancer Stage ◽  
Independent Prognostic Marker ◽  
Oral Cancer Patients ◽  
The Impact

Background and objectives: Krüppel-like transcription factor 10 (KLF10) plays a vital role in regulating cell proliferation, including the anti-proliferative process, activation of apoptosis, and differentiation control. KLF10 may also act as a protective factor against oral cancer. We studied the impact of KLF10 expression on the clinical outcomes of oral cancer patients to identify its role as a prognostic factor in oral cancer. Materials and Methods: KLF10 immunoreactivity was analyzed by immunohistochemical (IHC) stain analysis in 286 cancer specimens from primary oral cancer patients. The prognostic value of KLF10 on overall survival was determined by Kaplan–Meier analysis and the Cox proportional hazard model. Results: High KLF10 expression was significantly associated with male gender and betel quid chewing. The 5-year survival rate was greater for patients with high KLF10 expression than for those with low KLF10 expression (62.5% vs. 51.3%, respectively; p = 0.005), and multivariate analyses showed that high KLF10 expression was the only independent factor correlated with greater overall patient survival. The significant correlation between high KLF10 expression and a higher 5-year survival rate was observed in certain subgroups of clinical parameters, including female gender, non-smokers, cancer stage T1, and cancer stage N0. Conclusions: KLF10 expression, detected by IHC staining, could be an independent prognostic marker for oral cancer patients.

scholarly journals Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial

ISRN Nursing ◽  
2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Paul Ratanasiripong ◽  
Nop Ratanasiripong ◽  
Duangrat Kathalae
Keyword(s):  
Nursing Students ◽  
Stress Level ◽  
Clinical Training ◽  
Intervention Program ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Moderate Increase ◽  
Randomized Controlled ◽  
The Impact

Purpose. It has been well documented that nursing students across the world experience stress and anxiety throughout their education and training. The purpose of this randomized controlled study is to investigate the impact of biofeedback intervention program on nursing students' levels of stress and anxiety during their first clinical training. Methods. Participants consisted of 60 second-year baccalaureate nursing students. The 30 participants in the biofeedback group received training on how to use the biofeedback device to assist in stress and anxiety management for 5 weeks while the 30 in the control group did not receive any training. Findings. Results indicated that the biofeedback group was able to maintain the stress level while the control group had a significant increase in the stress level over the 5-week period of clinical training. Additionally, the biofeedback group had a significant reduction in anxiety, while the control group had a moderate increase in anxiety. Conclusions. The better the nursing students can manage their stress and anxiety, the more successful they can be in their clinical training. Ultimately, the more psychologically healthy the nursing students are, the more likely they will flourish and graduate to become productive and contributing members of the nursing profession.

scholarly journals Efficacy of folinic acid rescue following MTX GVHD prophylaxis: results of a double-blind, randomized, controlled study

2020 ◽  
Vol 4 (16) ◽  
pp. 3822-3828
Author(s):  
Moshe Yeshurun ◽  
Uri Rozovski ◽  
Oren Pasvolsky ◽  
Ofir Wolach ◽  
Ron Ram ◽  
...  
Keyword(s):  
Folinic Acid ◽  
Oral Mucositis ◽  
Hematopoietic Cell Transplantation ◽  
Controlled Trial ◽  
Chronic Gvhd ◽  
Controlled Study ◽  
Double Blind ◽  
Randomized Controlled ◽  
Gvhd Prophylaxis ◽  
Organ Specific

Abstract The use of methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis is associated with increased rates of organ-specific toxicities. Despite limited data, the European Society for Blood and Marrow Transplantation-European LeukemiaNet working group recommend the use of folinic acid (FA) rescue to reduce MTX toxicity after allogeneic hematopoietic cell transplantation (allo-HCT). In a multicenter, double-blind, randomized, controlled trial, we explored whether FA rescue reduces MTX-induced toxicity. We enrolled patients undergoing allo-HCT with myeloablative conditioning with peripheral blood stem cell grafts, with GVHD prophylaxis consisting of cyclosporine and MTX. Patients were randomized to receive FA or placebo starting 24 hours after each MTX dose and continuing over 24 hours in 3 to 4 divided doses. The primary end point was the rate of grades 3 and 4 oral mucositis. After enrollment of 52 patients (FA, n = 28; placebo, n = 24), preplanned interim analysis revealed similar rates of grade 3 and 4 (46.6% vs 45.8%; P = .97) and grades 1 to 4 (83.3% vs 77.8%; P = .65) oral mucositis. With a median follow-up of 17 (range, 4.5-50) months, there was no difference in the rates of acute and chronic GVHD, disease relapse, nonrelapse mortality, and overall survival. These interim results did not support continuation of the study. We conclude that FA rescue after MTX GVHD prophylaxis does not decrease regimen-related toxicity or affect transplantation outcomes. This study was registered at clinicaltrials.gov as #NCT02506231.

scholarly journals TROG 18.01 phase III randomised clinical trial of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation: NINJA study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e030731 ◽  
Author(s):  
Jarad Martin ◽  
Paul Keall ◽  
Shankar Siva ◽  
Peter Greer ◽  
David Christie ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Performance Status ◽  
Androgen Deprivation ◽  
Phase Iii ◽  
High Dose ◽  
The Novel ◽  
Ecog Performance Status ◽  
Initial Portion ◽  
The Impact

IntroductionStereotactic body radiotherapy (SBRT) is a non-invasive alternative to surgery for the treatment of non-metastatic prostate cancer (PC). The objectives of the Novel Integration ofNew prostate radiation schedules with adJuvant Androgen deprivation (NINJA) clinical trial are to compare two emerging SBRT regimens for efficacy with technical substudies focussing on MRI only planning and the use of knowledge-based planning (KBP) to assess radiotherapy plan quality.Methods and analysisEligible patients must have biopsy-proven unfavourable intermediate or favourable high-risk PC, have an Eastern Collaborative Oncology Group (ECOG) performance status 0-1 and provide written informed consent. All patients will receive 6 months in total of androgen deprivation therapy. Patients will be randomised to one of two SBRT regimens. The first will be 40 Gy in five fractions given on alternating days (SBRT monotherapy). The second will be 20 Gy in two fractions given 1 week apart followed 2 weeks later by 36 Gy in 12 fractions given five times per week (virtual high-dose rate boost (HDRB)). The primary efficacy outcome will be biochemical clinical control at 5 years. Secondary endpoints for the initial portion of NINJA look at the transition of centres towards MRI only planning and the impact of KBP on real-time (RT) plan assessment. The first 150 men will demonstrate accrual feasibility as well as addressing the KBP and MRI planning aims, prior to proceeding with total accrual to 472 patients as a phase III randomised controlled trial.Ethics and disseminationNINJA is a multicentre cooperative clinical trial comparing two SBRT regimens for men with PC. It builds on promising results from several single-armed studies, and explores radiation dose escalation in the Virtual HDRB arm. The initial component includes novel technical elements, and will form an important platform set for a definitive phase III study.Trial registration numberANZCTN 12615000223538.

Increased Incidence of Osteonecrosis (ON) with a Dexamethasone (DEX) Induction for High Risk Acute Lymphoblastic Leukemia (HR-ALL): A Report from the Children’s Oncology Group (COG).

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 898-898 ◽  
Author(s):  
Leonard A. Mattano ◽  
James B. Nachman ◽  
Meenakshi Devidas ◽  
Naomi Winick ◽  
Elizabeth Raetz ◽  
...  
Keyword(s):  
Lymphoblastic Leukemia ◽  
Initial Study ◽  
Intrathecal Methotrexate ◽  
High Dose ◽  
Historical Comparison ◽  
Randomized Design ◽  
Age Cohort ◽  
Methotrexate Dose ◽  
Grade 3 ◽  
The Impact

Abstract Treatment with DEX, rather than prednisone (PRED), improves outcome for children with standard risk ALL. However, DEX exposure is strongly associated with the development of therapy-related ON, particularly in adolescents. Previous COG HR-ALL studies have shown a lower ON risk for patients receiving 1 vs. 2 delayed intensification (DI) phases, and for DI using discontinuous DEX (days 1–7 & 15–21) vs. continuous DEX (days 1–21), suggesting a strategy for giving the drug with acceptable toxicity. The HRALL study COG AALL0232 utilizes a modified augmented BFM backbone that compares in a 2x2 randomized design: induction DEX (10 mg/M2/day x14 days) vs PRED (60 mg/M2/day x28 days), and interim maintenance (IM) escalating-dose “Capizzi” methotrexate vs. high-dose (HD) MTX. Induction rapid early responders (RER) receive single DI while slow responders receive double DI; all patients receive monthly 5-day DEX pulses during maintenance. To limit ON risk in adolescents, in the initial study design children ≥ 13y received discontinuous DEX during single or double DI; those <13y received continuous DEX. In 10/2006 the study was amended due to an unexpectedly high ON incidence in patients 10–12y receiving continuous DEX (28% @ 18 months) compared with historical controls given discontinuous DEX (3.4%). Subsequently all patients ≥ 10y have received discontinuous DEX; it is too early to assess the impact of this change. A comprehensive interim ON analysis was completed 4/2008 (reported as 24-month cumulative incidences). Overall ON incidence is 10.4% (110/1647), and is higher for those age ≥ 10 vs. <10y (15.2 vs 2.6%, p<0.0001, RHR=6.38); 99/110 cases of ON occurred in the older cohort. Among all patients, ON incidence is higher in DEX vs. PRED regimens (11.6 vs 8.7%, p=0.014, RHR 1.64); rates are similar for Capizzi MTX vs. HD-MTX regimens (10.4 vs 9.8%). Among patients ≥ 13y, incidence is higher in DEX vs. PRED regimens (18.9 vs 9.9%, p=0.02, RHR 1.97). There is no difference between regimens for children <10y. Among randomized RER patients ≥ 10y, incidence is higher in DEX vs. PRED regimens (17.2 vs 12.6%, p=0.006, RHR=1.79). For historical comparison, ON incidences by age cohort for RER patients on AALL0232 regimen PC (PRED + Capizzi MTX) vs. CCG-1961 regimen D (double DI with discontinuous DEX) were: <10y 4.1±3.4 vs. 2.0±1.4%, 10–12y 21.9±10.6 vs. 7.1±2.8%, and ≥ 13y 7.1±10.1 vs. 6.6±3.8%. To address these findings, the study was amended 6/2008. Patients ≥ 10y will be non-randomly assigned to induction PRED; the induction steroid randomization will continue for younger patients. Patients of all ages will receive discontinuous DEX during DI and PRED pulses during maintenance. Of note, compared with CCG-1961 the AALL0232 augmented BFM backbone was non-randomly modified in several ways that may affect ON incidence, including the use of pegaspargase during induction, a higher 15 mg intrathecal methotrexate dose for those age ≥ 9y, and monthly DEX instead of PRED maintenance pulses. Heightened awareness among caregivers may also have led to increased recognition and reporting of this toxicity. Using CTCAE v3.0 criteria, clinical ON severity among the 110 patients is: 3% grade 1, 60% grade 2, 35% grade 3, and 2% grade 4. Data regarding surgical intervention are being collected. These findings will directly influence the design of future trials in an effort to lessen the incidence and burden of this toxicity.

Sign in / Sign up

Export Citation Format

Share Document