Safety and efficacy of an intra-oral electrostimulator for the relief of dry mouth in patients with chronic graft versus host disease: case Series

Objectives: Patients with chronic graft-versus-host disease (cGVHD) often suffer from dry mouth and oral mu - cosal lesions. The primary objective of this study was to investigate the safety of an intra-oral electrostimulator (GenNarino) in symptomatic cGVHD patients. The secondary objective was to study the impact on the salivary gland involvement of cGVHD patients. Study Design: This paper presents a case series. The study included patients treated for 4 weeks, randomly as - signed to the active device and then crossed-over to a sham-device or vice versa. The patients and clinicians were blind to the treatment delivered. Data regarding oral mucosal and salivary gland involvement were collected. Results: Six patients were included in this series. Most of the intraoral areas with manifestations of cGVHD were not in contact with the GenNarino device. Two patients developed mild mucosal lesions in areas in contact with the GenNarino during the study. However, only one of them had a change in the National Institutes of Health (NIH) score for oral cGVHD. The unstimulated and stimulated salivary flow rate increased in 4 out of the 5 pa - tients included in this analysis. Symptoms of dry mouth and general oral comfort improved. Conclusion: This study suggests that GenNarino is safe in cGVHD patients with respect to oral tissues. Furthermore the use of GenNarino resulted in subjective and objective improvements in dry mouth symptoms. A large scale study is needed to confirm the impact and safety of GenNarino on systemic cGVHD

Sclerotherapy of Vascular Malformations in the Oral Cavity—Minimizing Postoperative Morbidity

Vascular malformations (VMs) are a wide vascular or lymphatic group of lesions common on the head and neck. The objective of this study was to assess the efficacy and morbidity of sclerotherapy for the treatment of VMs in the oral and perioral area. Special attention was given to factors that may contribute to minimizing postoperative morbidity. Data from 25 patients (32 lesions) with oral VMs submitted to sclerotherapy with monoethanolamine oleate (EAO) were included. A structured form was used to collect data. An arbitrary score was determined to evaluate postoperative morbidity. Each of the following signs or symptoms received one point: pain, swelling, hematoma, ulceration, erythema, transient numbness, and transient itching. Pain and swelling were further divided into mild to moderate (1 point) and severe (2 points). Theoretically, the score was in the range of 0–9. Calculated scores ranged 0–4. The patients were further divided into two groups with scores of 0–1 denoting minimal morbidity (MIN) and 2–4 denoting significant morbidity (SIG). The number of lesions in each morbidity-score group were comparable (MIN 17and SIG 15). There were no statistically significant differences between the groups regarding age, number of applications, or average injection volume per mm lesion. Statistically significant differences were noted regarding gender (p = 0.05), lesion diameter (p = 0.030), total volume of first (p = 0.007) and second application (p = 0.05), and total injected volume (p = 0.03). Factors contributing to the risk for significant morbidity included being male, lesion diameter > 5 mm, volume > 0.3 mL per application, and total injected volume > 0.3 mL. A waiting time of 12 weeks prior to additional EAO application was required in 12 out of 29 lesions for clinical observation of complete regression. It was concluded that sclerotherapy with EAO as monotherapy is easy to apply, safe, and effective within a small number of sessions. Application of <0.3 mL EAO per session, and a waiting time of 12 weeks prior to the second application, would significantly minimize morbidity

Sclerotherapy of Vascular Malformations in the Oral Cavity—Minimizing Postoperative Morbidity

Vascular malformations (VMs) are a wide vascular or lymphatic group of lesions common on the head and neck. The objective of this study was to assess the efficacy and morbidity of sclerotherapy for the treatment of VMs in the oral and perioral area. Special attention was given to factors that may contribute to minimizing postoperative morbidity. Data from 25 patients (32 lesions) with oral VMs submitted to sclerotherapy with monoethanolamine oleate (EAO) were included. A structured form was used to collect data. An arbitrary score was determined to evaluate postoperative morbidity. Each of the following signs or symptoms received one point: pain, swelling, hematoma, ulceration, erythema, transient numbness, and transient itching. Pain and swelling were further divided into mild to moderate (1 point) and severe (2 points). Theoretically, the score was in the range of 0–9. Calculated scores ranged 0–4. The patients were further divided into two groups with scores of 0–1 denoting minimal morbidity (MIN) and 2–4 denoting significant morbidity (SIG). The number of lesions in each morbidity-score group were comparable (MIN 17and SIG 15). There were no statistically significant differences between the groups regarding age, number of applications, or average injection volume per mm lesion. Statistically significant differences were noted regarding gender (p = 0.05), lesion diameter (p = 0.030), total volume of first (p = 0.007) and second application (p = 0.05), and total injected volume (p = 0.03). Factors contributing to the risk for significant morbidity included being male, lesion diameter > 5 mm, volume > 0.3 mL per application, and total injected volume > 0.3 mL. A waiting time of 12 weeks prior to additional EAO application was required in 12 out of 29 lesions for clinical observation of complete regression. It was concluded that sclerotherapy with EAO as monotherapy is easy to apply, safe, and effective within a small number of sessions. Application of <0.3 mL EAO per session, and a waiting time of 12 weeks prior to the second application, would significantly minimize morbidity

Tumor Treating Fields (TTFields) Concomitant with Sorafenib Inhibit Hepatocellular Carcinoma In Vitro and In Vivo

Hepatocellular carcinoma (HCC), a highly aggressive liver cancer, is a leading cause of cancer-related death. Tumor Treating Fields (TTFields) are electric fields that exert antimitotic effects on cancerous cells. The aims of the current research were to test the efficacy of TTFields in HCC, explore the underlying mechanisms, and investigate the possible combination of TTFields with sorafenib, one of the few front-line treatments for patients with advanced HCC. HepG2 and Huh-7D12 human HCC cell lines were treated with TTFields at various frequencies to determine the optimal frequency eliciting maximal cell count reduction. Clonogenic, apoptotic effects, and autophagy induction were measured. The efficacy of TTFields alone and with concomitant sorafenib was tested in cell cultures and in an orthotopic N1S1 rat model. Tumor volume was examined at the beginning and following 5 days of treatment. At study cessation, tumors were weighed and examined by immunohistochemistry to assess autophagy and apoptosis. TTFields were found in vitro to exert maximal effect at 150 kHz, reducing cell count and colony formation, increasing apoptosis and autophagy, and augmenting the effects of sorafenib. In animals, TTFields concomitant with sorafenib reduced tumor weight and volume fold change, and increased cases of stable disease following treatment versus TTFields or sorafenib alone. While each treatment alone elevated levels of autophagy relative to control, TTFields concomitant with sorafenib induced a significant increase versus control in tumor ER stress and apoptosis levels, demonstrating increased stress under the multimodal treatment. Overall, TTFields treatment demonstrated efficacy and enhanced the effects of sorafenib for the treatment of HCC in vitro and in vivo, via a mechanism involving induction of autophagy

Correction: Davidi et al. Tumor Treating Fields (TTFields) Concomitant with Sorafenib Inhibit Hepatocellular Carcinoma <i>In Vitro</i> and <i>In Vivo</i>. <i>Cancers</i> 2022, <i>14</i>, 2959

The authors wish to make minor corrections to Figure 1 and Figure 2 of the following paper [...

Intraoralelectrostimulator for xerostomia relief : along-term, multicenter, open-label, uncontrolled, clinical trial

OBJECTIVE: A previous sham-controlled multinational study demonstrated the short-term efficacy and safety for xerostomia treatment of an intraoral device that delivers electrostimulation to the lingual nerve. The objective of this study was to test the hypothesis that those beneficial effects would be sustained over an 11-month period. STUDY DESIGN: The device was tested on a mixed sample of 94 patients with xerostomia in an open-label, uncontrolled, prospective multicenter trial. Statutory outcome assessments were done at 5th, 8th, and 11th months and analyzed by multiple comparisons. RESULTS: Improvements achieved at month 5 from baseline were sustained throughout the follow-up period for the primary outcome, xerostomia severity, and the secondary outcomes resting whole salivary flow rate, xerostomia frequency, oral discomfort, and difficulties in speech, swallowing, and sleeping. No significant side effects were detected. CONCLUSIONS: The beneficial effects of a removable intraoral electrostimulating device were sustained for an 11-month period

Efficacy and Safety of an Intraoral Electrostimulation Device for Xerostomia Relief A Multicenter, Randomized Trial

Objective. To evaluate the efficacy and safety of an intraoral electrostimulation device, consisting of stimulating electrodes, an electronic circuit, and a power source, in treating xerostomia. The device delivers electrostimulation through the oral mucosa to the lingual nerve in order to enhance the salivary reflex

Intraoral electrostimulator for xerostomia relief: a long-term, multicenter, open-label, uncontrolled, clinical trial

Objective. A previous sham-controlled multinational study demonstrated the short-term efficacy and safety for xerostomia treatment of an intraoral device that delivers electrostimulation to the lingual nerve. The objective of this study was to test the hypothesis that those beneficial effects would be sustained over an 11-month period