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 Effect ofKangfuxinSolution on Chemo/Radiotherapy-Induced Mucositis in Nasopharyngeal Carcinoma Patients: A Multicenter, Prospective Randomized Phase III Clinical Study

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Yangkun Luo ◽  
Mei Feng ◽  
Zixuan Fan ◽  
Xiaodong Zhu ◽  
Feng Jin ◽  
...  
Keyword(s):  
Clinical Study ◽  
Nasopharyngeal Carcinoma ◽  
Adverse Events ◽  
Oral Mucositis ◽  
Rating Scale ◽  
Test Group ◽  
Phase Iii ◽  
Control Group ◽  
Oral Pain ◽  
Gastrointestinal Mucositis

Objective. To evaluate the efficacy and safety ofKangfuxinSolution, a pure Chinese herbal medicine, on mucositis induced by chemoradiotherapy in nasopharyngeal carcinoma patients.Methods. A randomized, parallel-group, multicenter clinical study was performed. A total of 240 patients were randomized to receive eitherKangfuxinSolution (test group) or compound borax gargle (control group) during chemoradiotherapy. Oral mucositis, upper gastrointestinal mucositis, and oral pain were evaluated by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 and the Verbal Rating Scale (VRS).Results. Of 240 patients enrolled, 215 were eligible for efficacy analysis. Compared with the control group, the incidence and severity of oral mucositis in the test group were significantly reduced (P=0.01). The time to different grade of oral mucositis occurrence (grade 1, 2, or 3) was longer in test group (P<0.01), and the accumulated radiation dose was also higher in test group comparing to the control group (P<0.05). The test group showed lower incidence of oral pain and gastrointestinal mucositis than the control group (P<0.01). No significant adverse events were observed.Conclusion.KangfuxinSolution demonstrated its superiority to compound borax gargle on mucositis induced by chemoradiotherapy. Its safety is acceptable for clinical application.

Evaluation of pain management in medical transfer of trauma patients by air

CJEM ◽  
2019 ◽  
Vol 21 (6) ◽  
pp. 776-783
Author(s):  
Isabelle H. Miles ◽  
Russell D. MacDonald ◽  
Sean W. Moore ◽  
James Ducharme ◽  
Christian Vaillancourt
Keyword(s):  
Pain Management ◽  
Adverse Events ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Trauma Centre ◽  
Air Transport ◽  
Future Research ◽  
Trauma Patients ◽  
Numerical Rating ◽  
Standard Deviation Range

ABSTRACTObjectivesWith regionalized trauma care, medical transport times can be prolonged, requiring paramedics to manage patient care and symptoms. Our objective was to evaluate pain management during air transport of trauma patients.MethodsWe conducted a 12-month review of electronic paramedic records from a provincial critical care transport agency. Patients were included if they were ≥18 years old and underwent air transport to a trauma centre, and excluded if they were Glasgow Coma Scale score <14, intubated, or accompanied by a physician or nurse. Demographics, injury description, and transportation parameters were recorded. Outcomes included pain assessment via 11-point numerical rating scale, patterns of analgesia administration, and analgesia-related adverse events. Results were reported as mean ± standard deviation, [range], (percentage).ResultsWe included 372 patients: 47.0 years old; 262 males; 361 blunt injuries. Transport duration was 82.4 ± 46.3 minutes. In 232 (62.4%) patients who received analgesia, baseline numerical rating scale was 5.9 ± 2.5. Fentanyl was most commonly administered at 44.3 [25–60] mcg. Numerical rating scale after first analgesia dose decreased by 1.1 [-2–7]. Thereafter, 171 (73.7%) patients received 2.4 [1-18] additional doses. While 44 (23.4%) patients had no change in numerical rating scale after first analgesia dose, subsequent doses resulted in no change in numerical rating scale in over 65% of patients. There were 43 adverse events recorded, with nausea the most commonly reported (39.5%).ConclusionsInitial and subsequent dose(s) of analgesic had minimal effect on pain as assessed via numerical rating scale, likely due in part to inadequate dosing. Future research is required to determine and address the barriers to proper analgesia.

Acute Enterocolitis Incidence in Patients with Hematological Malignancies Receiving Myelotoxic Therapy Requiring Hematopoietic Stem Cell Support - Palifermin Experience.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 5461-5461
Author(s):  
Isabel Sousa ◽  
Catarina Geraldes
Keyword(s):  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Adverse Events ◽  
Stem Cell Transplantation ◽  
Parenteral Nutrition ◽  
Hematopoietic Stem Cell ◽  
Oral Mucositis ◽  
Hematological Malignancies ◽  
Control Group ◽  
Hematopoietic Stem

Abstract Background: Chemotherapeutic agents can cause severe oral and gastrointestinal mucositis, for which there is currently no treatment. Previous research demonstrates that palifermin - keratinocyte growth factor - is potentially antimucotoxic, reducing the duration and severity of oral mucositis after intense chemotherapy in hematological cancers. The primary aim of this study was to determine palifermin effectiveness in ameliorating chemotherapy-induced diarrhoea and oral mucositis incidence. Palifermin adverse events were also assessed. Methods: Retrospective observational study involving patients with hematological malignancies undergoing autologous hematopoietic stem-cell transplantation after myelotoxic therapy. All the patients received antibiotic, antifungal, and antiviral prophylaxis. Patients being treated with palifermin to decrease the incidence and duration of severe oral mucositis (Palifermin Group) were compared to a control group of patients who did not receive palifermin (Control Group). Palifermin was administered during 3 consecutive days, before and after myelotoxic therapy in a 60 μg/Kg daily intravenous dose. Results: Twenty-four patients were included, 8 in Palifermin Group and 16 in Control Group. Baseline malignancies were Hodgkin and non Hodgkin lymphoma, acute myeloid leukemia, and multiple myeloma. All patients underwent autologous hematopoietic stem-cell transplantation after the following conditioning regimes: BEAM, BuCy, and Mel200 respectively. In Palifermin Group, 62.5% were male, mean age 47.6±13.0 years, mean disease duration of 22.3±10.1 months (N=8). In Control Group 56.3% were male, mean age 45.8±12.1 years (N=16). Mean performance status (Karnofsky Index) was 80±14.1% and 71.3±15.1%, in each group, respectively. No statistically significant differences between Palifermin and Control Groups were found regarding the degree of diarrhoea, although in the Palifermin Group the majority of patients presented a grade 2 (N=3) and in the Control Group a grade 3 (N=6). In the Palifermin Group there was a tendency for a lower incidence of hypoalbuminemia [12.5% (Palifermin Group) vs. 50% (Control Group)], which corresponded to a significant lower difference in the needs for receiving parenteral nutrition (P=0.011). Nevertheless, these findings were not translated in less febrile episodes or less iv antibiotic therapy days. There were no significant differences between the two groups regarding the degree of oral mucositis, the number of days of analgesic opioids use, and the number of hospitalization days, most probably due to the small sample considered. The most common adverse events in the Palifermin Group were reversible erythema and edema of the face and upper trunk that have occurred only in 3 patients. Weight increase was mild and similar in both groups of patients [Median weight increase±SD: 1,0±1,7 Kg (Palifermin Group) vs 2,0±2,5 Kg (Control group)]. Conclusion: Gastrointestinal and oral mucositis are common consequences of cancer therapy with a direct and significant impact on the quality of life and care costs, also affecting patient’s survival. Our exploratory study shows that palifermin treatment is well tolerated, potentially reducing diarrhoea and the incidence of hypoalbuminemia, and significantly reducing the needs for parenteral nutrition. However further studies with an increased number of patients will be necessary to provide more evidence concerning palifermin efficacy in the management of these cancer therapy’s debilitating side-effects.

scholarly journals Effect of Mirogabalin on Chemotherapy-Induced Peripheral Neuropathy Caused by Gemcitabine Plus Nab-Paclitaxel Therapy in Pancreatic Cancer Patients: A Pilot Study

2021 ◽  
Author(s):  
Yusuke Takasaki ◽  
Toshio Fujisawa ◽  
Mako Ushio ◽  
Sho Takahashi ◽  
Wataru Yamagata ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Peripheral Neuropathy ◽  
Pilot Study ◽  
Adverse Events ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Sensory Neuropathy ◽  
Life Questionnaire ◽  
European Organization ◽  
Patient Reported

Abstract Purpose: Gemcitabine/nab-paclitaxel (GnP) therapy is widely used to treat pancreatic cancer (PC), but chemotherapy-induced peripheral neuropathy (CIPN) is common. Mirogabalin is a novel drug for treating peripheral neuropathy. We investigated the effects of mirogabalin on CIPN due to GnP therapy in PC patients.Methods: This was a single-center retrospective pilot study. Patients who had previously received or were currently receiving GnP for PC and had taken mirogabalin for at least 2 weeks for CIPN, were included. Patients completed a questionnaire about their symptoms before and after taking mirogabalin. The primary outcome was the change in numbness and tingling scores on the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Secondary outcomes were the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN20) (Japanese version) score, numerical rating scale (NRS) pain score, and adverse events (AEs).Results: Increased numbness and tingling severity (1.84 vs. 1.76; P=0.63) and interference with daily life (1.42 vs. 1.44; P=0.80) were not seen in any of the 25 enrolled patients. The scores on the sensory subscale of the QLQ-CIPN improved significantly after treatment (17.5 vs. 15.7; P=0.02). AEs occurred in 22 patients (88%), but there were no serious AEs (≥ grade 3).Conclusions: Mirogabalin may control the progression of CIPN caused by GnP therapy in PC patients, and improved sensory neuropathy significantly in our patients. However, since the incidence of AEs is high, mirogabalin should be used with caution.

scholarly journals Open-label phase 3 study of diclofenac conjugated to hyaluronate (diclofenac etalhyaluronate: ONO-5704/SI-613) for treatment of osteoarthritis: 1-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yoshihiro Nishida ◽  
Kazuyuki Kano ◽  
Taiki Osato ◽  
Takayuki Seo
Keyword(s):  
Adverse Events ◽  
Joint Pain ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Open Label ◽  
Phase 3 ◽  
X Ray ◽  
Knee Oa ◽  
Pain Scores ◽  
X Ray Imaging

Abstract Background We evaluated the 1-year safety and efficacy of diclofenac etalhyaluronate (DF-HA), a diclofenac-conjugated hyaluronate, in patients with osteoarthritis (OA). Methods In this multi-centre, open-label, noncomparative phase 3 study in Japan, patients with a diagnosis of knee, shoulder, elbow, hip, or ankle OA received an intra-articular (IA) injection of DF-HA 30 mg every 4 weeks for 1 year (13 times in total). The safety outcomes included treatment-emergent adverse events (TEAEs) and target joint structural changes by X-ray imaging tests. Efficacy outcomes included joint pain scores on an 11-point numerical rating scale. Concomitant use of analgesics was not restricted. Results Overall, 166 eligible patients were enrolled, comprising knee OA (n = 126) and other OA (n = 40). All TEAEs were experienced by 126/166 patients (75.9%). The incidence of treatment-related TEAEs was not associated with the treatment period. No significant worsening of joint status was observed in X-ray imaging tests at week 52 or at last assessment. The mean joint pain scores (± standard deviation) were 5.9 ± 1.2, 4.9 ± 1.9, and 3.1 ± 2.3 at baseline, and weeks 2 and 52, respectively. Improvement of pain score was observed after the first injection and was maintained until week 52 regardless of knee OA or other joint OA. Conclusions Repeated IA injections of DF-HA every 4 weeks for 1 year were well tolerated with no clinically significant adverse events indicating they might lead to the long-term improvement of OA symptoms. DF-HA might be a useful treatment for patients with OA. Trial registration number JapicCTI-183855 (First registered date: 6th February 2018).

scholarly journals Long-term outcomes of antibiotic combination therapy for ulcerative colitis

2021 ◽  
Vol 12 ◽  
pp. 204062232110287
Author(s):  
Yuriko Nishikawa ◽  
Nobuhiro Sato ◽  
Shintaro Tsukinaga ◽  
Kan Uchiyama ◽  
Shigeo Koido ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Side Effects ◽  
Adverse Events ◽  
Medical Information ◽  
Compliance Rate ◽  
University Hospital ◽  
Open Label ◽  
Antibiotic Combination

Aims: An antibiotic combination of amoxicillin, tetracycline and metronidazole (ATM) is effective for ulcerative colitis (UC), but this regimen is discontinued in some cases due to adverse events. This study aimed to assess a revised combination, namely, amoxicillin, fosfomycin and metronidazole (AFM), in UC patients with the goal of reducing side effects while maintaining therapeutic efficacy. Methods: A prospective open-label trial was undertaken in 104 adult UC patients. A combination of oral amoxicillin (1500 mg), fosfomycin (3000 mg) and metronidazole (750 mg) was administered to patients daily for 2–4 weeks in addition to their conventional medication. Clinical assessment was performed using the Lichtiger index before treatment and at 0, 3, 6, 9 and 12 months and 2 and 3 years. Endoscopic evaluation was performed using the Mayo score before treatment and at 3 and 12 months. Results: The compliance rate was 99.2%. Response and remission rates were 80.8% and 63.5% at completion, 73.1% and 64.4% at 3 months, and 39.4% for both at 12 months, respectively. Of the 41 patients who were in remission at 12 months, 63.4% maintained that status until the 2-year follow-up. Similarly, 69.2% of those in remission at 2 years remained relapse free at the 3-year follow-up. Side effects were observed in 44.2% of the participants. Fever occurred in one patient (1.0%), which was lower than the rate observed with ATM therapy. Conclusion: These results indicate that AFM therapy induces remission and is appropriate for long-term maintenance of UC while producing fewer and milder adverse events than ATM therapy. Clinical trials: This study was registered in the University Hospital Medical Information Network (No. R000046546).

scholarly journals Therapeutic Effect of Polidocanol Sclerotherapy on Oral Vascular Malformations

2021 ◽  
Vol 9 (10) ◽  
pp. 119
Author(s):  
Satoshi Fukuzawa ◽  
Kenji Yamagata ◽  
Makiko Okubo-Sato ◽  
Kazuhiro Terada ◽  
Fumihiko Uchida ◽  
...  
Keyword(s):  
Therapeutic Effect ◽  
Rating Scale ◽  
Oral Surgery ◽  
Numerical Rating Scale ◽  
Vascular Malformations ◽  
Treatment Method ◽  
Magnetic Resonance Images ◽  
University Hospital ◽  
Therapeutic Effects ◽  
Average Size

Various treatments for oral vascular malformation (VM) have been reported. Polidocanol and absolute ethanol have also been reported for sclerotherapy. However, there are still few reports on the therapeutic effect and dosage of polidocanol sclerotherapy. Therefore, we examined its therapeutic effects on oral VM. There were 17 sites of VMs, with nine patients diagnosed with oral VM at the Department of Dental and Oral Surgery, Tsukuba University Hospital. The medical records were retrospectively investigated to determine the site, hemangioma volume, polidocanol injection volume, and therapeutic effect. The volume of hemangiomas was calculated using magnetic resonance images. Based on the site, oral VMs were observed in the tongue, buccal mucosa, lips, and oral floor in eight, three, five, and one patients, respectively. The average size of the site was 3071 mm3. The average injection dose of polidocanol at one site was 2.86 mL, the average number of administrations was 1.6, and the response rate was 88.2%. No adverse events were observed. The median numerical rating scale scores were 2/10 (0–6/10) and 0/10 (0–1/10) the day after surgery and 1 week after surgery, respectively. Univariate regression analysis of the total dose in successful cases provided the following formula: 1.3 + 0.00025 × volume (mm3) (mg). Polidocanol sclerotherapy is an effective treatment method for oral VM.

A Randomized Placebo Controlled Phase II Trial of Prevention of Severe Oral Mucositis Using Single Dose Velafermin in Patients Receiving Myeloablative Therapy and Autologous Hematopoietic Stem Cell Transplant (AHSCT).

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 615-615 ◽  
Author(s):  
Michael W. Schuster ◽  
J. Mehta ◽  
E.K. Waller ◽  
R.M. Rifkin ◽  
I. Micallef ◽  
...  
Keyword(s):  
Stem Cell ◽  
Adverse Events ◽  
Oral Mucositis ◽  
Interim Analysis ◽  
Safety Information ◽  
Study Drug ◽  
Controlled Study ◽  
Cell Transplant ◽  
Hematopoietic Stem ◽  
Safety And Efficacy

Abstract Oral mucositis (OM) is a commonly occurring side effect in patients (pts) undergoing AHSCT. Velafermin, recombinant human fibroblast growth factor-20, is under investigation for the prevention of severe OM. Previous studies demonstrated that velafermin at 30 mcg/kg was well tolerated and was effective in reducing the incidence of severe mucositis. The primary objective of this multicenter, randomized, double-blind, placebo controlled study was to confirm safety and efficacy of 30 mcg/kg velafermin for prevention of severe OM incidence (grade 3/4 OM based on the WHO grading system). The secondary objective was to evaluate safety and efficacy of 10 and 60 mcg/kg doses to better define the therapeutic range. Pts were randomized to receive placebo or velafermin at 30, 10 or 60 mcg/kg in a 3:3:1:1 ratio 24–36 hrs after stem cell infusion. Randomization was stratified by study center and OM risk factors identified from the previous placebo controlled study in a similar population including conditioning regimen and body mass index (BMI ≥30). Pts with multiple myeloma or lymphoma (≥18 y.o.) receiving ≥2X106 /kg CD34+ cells following chemotherapy with or without Total Body Irradiation (TBI) were eligible. OM status and safety data were collected for 30 days post treatment while mortality and disease progression were followed for 1 yr. An interim analysis by a data monitoring committee (DMC) was planned to assess safety and efficacy after 50% of pts completed the 30 day treatment period. A total of 390 pts who received melphalan (200 mg/m2) (n=239), BEAM (n=129), TBI (n=15), or other (n=7) were randomized and 384 pts were treated. The study drug was well tolerated in general and no pts discontinued study due to drug-related adverse events. There were 93 serious adverse events (SAEs) in 78 (20%) pts and no drug-related death was reported. Five infusion-related SAEs were reported including vasovagal episode (2), syncope (2), and anaphylactoid reaction (1). All 5 episodes occurred on the day of study drug infusion and resolved on the same day with no sequelae. Based on review of the results from the interim analysis, which included safety and efficacy data from 200 pts, the DMC recommended that the study continue to completion as planned. The last pt has completed the 30 day study period. The un-blinded results of the OM efficacy endpoints from velafermin treated groups or placebo as well as 30-day safety information from all pts will be reported.

scholarly journals Fenugreek seed poultice versus cold cabbage leaves compresses for relieving breast engorgement: An interventional comparative study

2020 ◽  
Vol 10 (5) ◽  
pp. 82
Author(s):  
Hanan Elzeblawy Hassan ◽  
Eman Ali Abd El Moaty Sheha ◽  
Sharbat Thabet Hassanine ◽  
Wafaa Mostafa Ahmed Gamel
Keyword(s):  
Comparative Study ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Placebo Treatment ◽  
Nursing Intervention ◽  
Structured Interview ◽  
University Hospital ◽  
Painful Condition ◽  
Fenugreek Seed ◽  
The Impact

Background: Breast engorgement is an uncomfortable and painful condition affecting a large slid of mothers in their early postpartum period. Several approaches have been explored for pharmacological or non-pharmacological interventions applied to the treatment of breast engorgement. Some of the non-medical interventions include Fenugreek seed poultice and cold cabbage leaves compresses. Aim: Study the impact of nursing intervention on relieves of breast engorgement among puerperal breastfeeding women and compare Fenugreek seed poultice versus could cabbage leaves compresses as two different nursing care approaches of on relieving of breast-engorgement.Methods: Setting: Postnatal unit and outpatient clinic of Beni-Suef and El-Fayoum University Hospital. Design: A quasi-experimental comparative study. Subjects: A purposive sample of a total of 100 puerperal mothers; 50 in the Fenugreek group \& 50 in the cold Cabbage group. Tools: A specialized designed structured interview schedule and Breast Engorgement Assessment Scale (Numerical rating scale, Modified Reeda Scale, Six-points engorgement scale, Fever Chart, and LATCH breastfeeding charting scale).Results: A significant improvement of breast condition after intervention for both groups regardless of the applied measure was found; however, the improvement was better and shorter time among Fenugreek group than Cabbage group (p < .05). Conclusions: For the management of breast engorgement, both Fenugreek seed poultice and cold Cabbage leaves were effective. However, Fenugreek seed was more highly effective where breast engorgement was alleviated in a shorter time than cold Cabbage leaves. Recommendations: Further randomized controlled trials with possible placebo treatment should be carried out to elucidate the non-specific effects of Fenugreek seed poultice and cold Cabbage leaves application.

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