scholarly journals Primary evaluation of an air-cooling device to reduce oral mucositis: a pilot study in healthy volunteers

2020 ◽  
Vol 37 (12) ◽  
Author(s):  
C. Blacker ◽  
T. Kamsvåg ◽  
R. S. Bejhed ◽  
G. Ljungman
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Healthy Volunteers ◽  
Oral Mucosa ◽  
Oral Mucositis ◽  
Randomized Clinical Trials ◽  
Common Side Effect ◽  
Air Cooling ◽  
Temperature Reduction ◽  
Oral Cryotherapy

AbstractOral mucositis is a common side effect of chemo and radiotherapy causing painful ulcers in the oral mucosa. One of the preventive treatments recommended in international guidelines is oral cryotherapy (OC). Randomized clinical trials on OC have used ice and ice-chips to cool the mouth, but this cooling method can be difficult for the patients to tolerate. Studies have shown that OC with ice for a period of 60 min reduces the oral temperature by 12.9 °C. The aim of this pilot study was to evaluate the temperature reduction and tolerability of OC using an intra-oral air-cooling (IOAC) device in healthy volunteers. Twelve healthy volunteers, mean age 35.4 years, were included in the study. They were treated with OC using the IOAC device for 60 min. Measurements of temperature were obtained at baseline, 5 and 60 min using a FLIR® C2 camera. After the OC session, tolerability and adverse events were documented using a questionnaire. All participants were able to use the device for 60 min. The overall temperature reduction after 5 min of OC was 10.7°C (p < 0.01) and after 60 min 14.5°C (p < 0.01). The most common adverse events were bad fit of the mouthpiece (n = 6), hypersalivation (n = 6), and difficulties swallowing (n = 5). The oral device reduced the temperature of the oral mucosa as much as treatment with ice with tolerable adverse events. The mouthpiece will be remodeled to improve tolerability before further studies are conducted.

New Cooling Device for Oral Mucosa Better Tolerated and Equally Effective As Ice Cooling

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5806-5806
Author(s):  
Java Walladbegi ◽  
Anncarin Svanberg ◽  
Gunnar Birgegard ◽  
Mats Jontell
Keyword(s):  
Healthy Volunteers ◽  
Oral Mucosa ◽  
Oral Mucositis ◽  
Buccal Mucosa ◽  
Research Funding ◽  
Poor Quality ◽  
Cooling Device ◽  
Circulating Water ◽  
Temperature Reduction ◽  
Thermographic Camera

Abstract Introduction: Oral mucositis (OM) is an inflammation of the oral mucosa affecting up to 80% of all patients receiving myeloablative therapy prior to stem cell transplantation. The complication manifests as ulcerations and may require high doses of morphine for pain alleviation.OM may also interfere with food intakeand result in parenteral nutrition, weight loss and impaired quality of life. Current literature indicates very few evidence-based interventions for prevention of OM. Cryotherapy (CT),using ice chips has reported to efficiently reduced grade and extent of OM, although clinical use is still limited due to several disadvantages. These include adverse teeth sensations, nausea and uneven cooling of the oral mucosa. Moreovercontinuous supply of ice chips is needed during treatment sessions and thewater from which ice chips are made may be of poor quality, leading to health hazards. Objectives: The primary endpoint of the present study was to evaluate the tolerability of an intraoral cooling device (Cooral) compared with ice chips. Secondary endpoints were temperature reduction and cooling distribution. Methods:To avoid the adverse effects and reduce the disadvantages of ice chips an optimal fitting mouth-cooling device (Fig. 1), shaped and dimensioned to cool the gums, cheeks, tongue, palate and base of the mouth was designed. Thecooling device is made of a closed channel system with continuous circulating water and has the advantage over ice chips as the water temperature can be adjusted. 20 healthy volunteers (mean age: 24 years) (17 women; 3 men) were enrolled in this cross over study. Each individual used the cooling device and ice chips for 60 minutes in two separate sessions with at least 24 hours apart. Prior to inclusion, the procedure was explained in writing and a written informed consent was obtained. Baseline- and final temperatures were measured (Fig. 2) in eight intraoral locations (right buccal mucosa, left buccal mucosa, upper labial mucosa, lower labial mucosa, anterior and posterior dorsal tongue, ventral tongue and hard palate) using an infrared thermographic camera (FLIR-60). Following each cooling session a questionnaire, specifically developed for the study to assess tolerability, was completed. In total 700 thermographic images were analysed using FlIR-60 tools software and BioPix. Results: The cooling device was found to be significantly better tolerated compared to ice chips and was preferred by 16 out of 20 participants (P=0.0118; Fig. 3). Three individuals preferred ice chips as they were frequently habitually chewing on ice. One individual reported that the device was experienced as too big, a problem that will be solved in the future, as three different sizes of the device will be produced. Finally, the device was found to be as efficient as ice chips in terms of cooling reduction and cooling distribution. Conclusions: The cooling device was significantly better tolerated and provided as efficient temperature reduction and cooling distribution as ice chips in healthy volunteers. The device has the potential not just to improve the comfort but in the long term also optimize the effect of cryotherapy with the aim of preventing oral mucositis. The next step in this research will be to evaluate the cooling device in a clinical setting to establish its tolerability and efficacy of preventing oral mucositis. FormulŠrets nederkant Disclosures Walladbegi: BraincCool: Employment, Research Funding. Svanberg:BrainCool: Employment, Research Funding. Jontell:BrainCool: Research Funding.

scholarly journals Effects of an Oral Mucosa Protective Formulation on Chemotherapy- and/or Radiotherapy-induced Oral Mucositis: A Prospective Study

2021 ◽  
Author(s):  
Takao Ueno ◽  
Wakako Yatsuoka ◽  
Hiroto Ishiki ◽  
Kanako Miyano ◽  
Yasuhito Uezono
Keyword(s):  
Adverse Events ◽  
Prospective Study ◽  
Oral Mucosa ◽  
Oral Mucositis ◽  
Medical Information ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
University Hospital ◽  
Hematopoietic Stem ◽  
Oral Pain

Abstract Background: Oral mucositis (OM) associated with cancer treatment not only impairs patients’ quality of life but also causes treatment delays or changes. This prospective exploratory study was conducted to evaluate the efficacy of episil® oral liquid, which is an approved protective formulation for the oral mucosa in patients with OM. The extent of the pain-relieving effect, feeling during use, and adverse events or problems were evaluated.Methods: In total, 10 Japanese cancer patients with OM receiving chemotherapy, hematopoietic stem cell transplantation, or radiation therapy for head and neck cancer were enrolled. Results: A numerical rating scale (NRS) was used to assess oral pain intensity due to OM. Compared to baseline, the mean NRS began to decrease at 5 mins after using episil (7.1 ± 1.4 to 4.6 ± 2.87; p = 0.264). A significant decrease was observed in the pain score after using episil compared with that before using episil, and this effect lasted up to 120 mins. The protective effects of episil were observed 3–5 mins after application. Some patients felt slight soreness or discomfort when applying episil. However, this discomfort due to episil’s stimulation was within the allowable range and transient. No adverse events were observed in any of the cases.Conclusions: The results of this prospective study showed that episil could be an effective treatment to relieve oral pain in Japanese patients with moderate to severe OM, and this newly approved product might adequately support patients’ oral intake.Trial registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) (UMIN000031921).

scholarly journals Safety and Immunogenicity of Combination of Vaccines – Covishield and Covaxin – a Pilot Study

2021 ◽  
Author(s):  
Bhanu Prakash Reddy Attunuru ◽  
Podduturi Naveenchander Reddy ◽  
Sasikala Mitnala ◽  
Gujjarlapudi Deepika ◽  
Sadhana Yelamanchili Veturi ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Observational Study ◽  
Immune Responses ◽  
Healthy Volunteers ◽  
Prospective Observational Study ◽  
Single Center ◽  
Rt Pcr ◽  
Combination Vaccines ◽  
Mix And Match

Abstract This single-center prospective observational study was conducted to assess the safety and immunogenicity of combination vaccines AstraZeneca’s ChAdOx1-nCov-19 (Covishield in India) and inactivated whole virion BBV152 (Covaxin). A total of 330 unvaccinated healthy volunteers were screened for SARS-COV2 seropositivity. RT PCR tests were conducted for seronegative volunteers (n =44). They were randomly assigned to four groups and given either same or mixed vaccines at an interval of 4 weeks between the two doses. Mix and match of vaccines did not evoke any adverse events. Combination of vaccines elicited similar immune responses in 4 groups. In Conclusion, Combination vaccines are safe and immunogenic.

Safety of Vinflunine in Patients with Advanced Urothelial Carcinoma Refractory to Platinum-based Chemotherapy: A Prospective Pilot Study

2019 ◽  
Vol 14 (1) ◽  
pp. 31-36
Author(s):  
Raafat Abdel-Malek ◽  
Kyrillus S. Shohdy ◽  
Noha Abbas ◽  
Mohamed Ismail ◽  
Emad Hamada ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Urothelial Carcinoma ◽  
Transitional Cell ◽  
Chemotherapeutic Agents ◽  
Serious Adverse Events ◽  
Platinum Based Chemotherapy ◽  
Number Of Patients ◽  
Advanced Urothelial Carcinoma ◽  
Grade 3

Background: Several single chemotherapeutic agents have been evaluated as the second-line treatment of advanced urothelial carcinoma. Despite encouraging efficacy outcomes, toxicity has often led to dose modifications or discontinuation. We aimed to assess the safety of vinflunine in a particular population of advanced transitional cell carcinoma of urothelium (TCCU), that were exposed to the previous toxicity of chemotherapy. Methods: This is an open-label, prospective, single-center pilot study to evaluate the response rate and safety profile of vinflunine in patients with advanced TCCU. It was planned to enroll 25 evaluable patients. Eligible patients are those with progressive disease after first-line platinum-based regimen for advanced or metastatic disease. Results: The study was prematurely closed due to two sudden deaths that were judged by the review board as treatment-related. Only ten patients were evaluated and received at least one cycle of vinflunine. All but one were male and seven underwent radical surgery. Eight had a distant metastasis (mainly lung and/or liver). Disease control rate was 40%, four patients had a partial response with median duration of response of 3.5 months. The median overall survival was 3.2 months (95% CI:1.67- 4.73). There were three serious adverse events namely two sudden deaths and one grade 4 thrombocytopenia. Nine grade 3/4 adverse events occurred. The most common all-grade adverse events were fatigue (50%), constipation (40%) and vomiting (40%). Moreover, grade 3 fatigue occurred in 30% of patients. Only one patient, who achieved PR for 5 months, was fit to receive further cytotoxic chemotherapy. Conclusion: The activity of vinflunine in advanced urothelial carcinoma came at the expense of its safety. The use of vinflunine has to be limited to the selected group of patients. However, this is a single institute experience in a limited number of patients.

The Detection of Adverse Events in Randomized Clinical Trials: Can we Really Say New Medicines are Safe?

2013 ◽  
Vol 8 (2) ◽  
pp. 104-113 ◽  
Author(s):  
Izyan Wahab ◽  
Nicole Pratt ◽  
Lisa Kalisch ◽  
Elizabeth Roughead
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Randomized Clinical Trials

scholarly journals 1288. Phase 1 First-in-Human Single- and Multiple-Ascending Dose Trial Demonstrates Pharmacokinetics (PK) and Tolerability of SPR720, an Oral DNA GyrB Inhibitor for Mycobacterial Infections

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S659-S659
Author(s):  
Angela Talley ◽  
Archie Thurston ◽  
Grayson Moore ◽  
Myriah M Satterfield ◽  
Erika L Manyak ◽  
...  
Keyword(s):  
Adverse Events ◽  
Healthy Volunteers ◽  
Controlled Trial ◽  
Phase 1 ◽  
Safety Data ◽  
Elderly Subjects ◽  
Independent Contractor ◽  
Serious Adverse Events ◽  
Healthy Elderly ◽  
Dose Proportional

Abstract Background SPR720 (phosphate pro-drug of SPR719) is a novel aminobenzimidazole bacterial DNA gyrase (GyrB) inhibitor in development for non-tuberculous mycobacterial lung disease (NTM-LD) and pulmonary tuberculosis. SPR719 has broad-spectrum activity versus clinically relevant mycobacteria in vitro and in murine and hollow fiber (HF) infection models. In this first-in-human single ascending dose (SAD) /multiple ascending dose (MAD) study, the safety, tolerability and pharmacokinetics (PK) of SPR720/SPR719 were evaluated in healthy volunteers. Methods This was a Phase 1 randomized, double-blind, placebo-controlled trial with 7 SAD cohorts (including a food effect cohort) and 5 MAD cohorts. Healthy volunteers (n=8/cohort, 3:1 randomization) received SPR720 or placebo in single oral doses of ranging from 100 mg to 2000 mg or repeat total daily doses ranging from 500 mg to 1500 mg for 7 or 14 days. Safety monitoring and PK sampling occurred throughout the trial. Plasma and urine concentrations of SPR720/SPR719 were measured by validated LC-MS/MS methods. PK parameters were calculated using non-compartmental analysis. Results A total of 96 subjects (including 8 healthy elderly subjects, age ≥ 65 years) were randomized and received study drug. SPR720 was well-tolerated at daily doses up to 1000 mg for up to 14 days. Across SAD/MAD cohorts, the most common adverse events were gastrointestinal (nausea, vomiting and diarrhea) and headache, all of mild or moderate severity and dose dependent. No serious adverse events were reported. Across SAD cohorts, a dose proportional and greater-than-dose proportional increase in SPR719 plasma Cmax and AUC0-24, respectively were observed. SPR720 was rapidly absorbed with a mean SPR719 t1/2 of 2.9-4.5 h. Dosing with food decreased SPR719 plasma AUC by ~20%. No clinically meaningful effect of age on plasma AUC was observed. In the MAD cohorts, SPR719 plasma exposure declined approximately 40% between Day 1 and Day 7, suggesting induction of an elimination pathway. However, plasma AUC0-24 was similar at Days 7 and 14. Conclusion Together with HF pharmacodynamic data, human PK and safety data for SPR720 suggest that predicted therapeutic exposures can be attained with a well-tolerated once-daily dose. Further evaluation in a Phase 2 NTM-LD trial is planned. Disclosures Angela Talley, MD, Spero Therapeutics (Employee, Shareholder) Archie Thurston, Jr., PhD, Spero Therapeutics (Consultant) Grayson Moore, BA, RN, Spero Therapeutics, Inc. (Shareholder, Independent Contractor) Vipul Kumar, PhD, Spero Therapeutics (Employee, Shareholder) Suzanne Stokes, PhD, Spero Therapeutics (Employee, Shareholder) Aaron Dane, MSc, Spero theraputics (Consultant) David Melnick, MD, Spero Therapeutics (Employee)Spero Therapeutics (Employee)

Sign in / Sign up

Export Citation Format

Share Document