Use of a natural multicomponent mouthwash plus oral hygiene vs oral hygiene alone to prevent everolimus-induced stomatitis: the STOP multicenter, randomized trial

2020 ◽  
Vol 106 (3) ◽  
pp. 257-266
Author(s):  
Camillo Porta ◽  
Elena Verzoni ◽  
Silvia Zai ◽  
Caterina Messina ◽  
Vittorio Ferrari ◽  
...  
Keyword(s):  
Oral Hygiene ◽  
Mammalian Target Of Rapamycin ◽  
Dose Intensity ◽  
Treated Group ◽  
Patients With Cancer ◽  
Treatment Dose ◽  
Registration Number ◽  
Study Population ◽  
To Receive

Background: Stomatitis is highly prevalent in patients with cancer treated with the mammalian target of rapamycin inhibitor everolimus; it usually has an early onset and may compromise treatment dose intensity and patients’ quality of life. Within the randomized controlled Stomatitis Prevention trial (STOP, ISRCTN14568888), we investigated the possibility of using a commercial natural multicomponent mouthwash (Orasol Plus®) to prevent the development of stomatitis of any grade in patients with advanced renal cell carcinoma (RCC) treated with everolimus. Methods: Overall, 62 patients were randomized to receive either Orasol Plus in addition to oral hygiene or oral hygiene alone (31 patients per treatment arm). Results: In the whole study population, 28 episodes of stomatitis were observed (41.9%); in only 2 patients, stomatitis occurred more than once (2 episodes). As expected, the episodes of stomatitis occurred early in the course of treatment with everolimus. Treatment with Orasol Plus prevented the onset of everolimus-induced stomatitis: only 8 episodes of stomatitis were observed in the treated group with Orasol Plus in addition to oral hygiene vs 20 episodes in the group treated with oral hygiene only ( p = 0021). Also, a reduction in the average duration of mucositis in patients treated with Orasol Plus compared to patients treated with oral hygiene only was observed (8 days vs 11.2 days, p = 0.0416). Conclusion: This study showed that the use of a natural multicomponent mouthwash coupled with regular oral hygiene was able to reduce the severity and duration of everolimus-induced stomatitis in patients with RCC. Trial registration number: ISRCTN14568888

Phase III Study of Two Different Dosing Schedules of Erythropoietin in Anemic Patients With Cancer

2006 ◽  
Vol 24 (7) ◽  
pp. 1079-1089 ◽  
Author(s):  
David P. Steensma ◽  
Roy Molina ◽  
Jeff A. Sloan ◽  
Daniel A. Nikcevich ◽  
Paul L. Schaefer ◽  
...  
Keyword(s):  
Maintenance Phase ◽  
Drug Dose ◽  
Phase Iii ◽  
Epoetin Alfa ◽  
Patients With Cancer ◽  
Global Quality ◽  
Global Quality Of Life ◽  
Phase Iii Study ◽  
To Receive

PurposeTo compare maintenance epoetin alfa administered once every 3 weeks with continued weekly epoetin alfa for patients with cancer-associated anemia.Patients and MethodsEligible patients were randomly assigned at enrollment to receive three weekly doses of epoetin alfa 40,000 U subcutaneously (SC), followed by either standard weekly epoetin alfa (40K arm) or 120,000 U of epoetin alfa (120K arm) SC every 3 weeks for 18 additional weeks.ResultsThree hundred sixty-five patients were enrolled. One hundred eighty-three patients were assigned to the 40K arm, and 182 were assigned to the 120K arm. There was no difference in the proportion of patients requiring transfusions during the study (23% in 40K arm and 18% in 120K arm, P = .22) or specifically during the maintenance phase (13% in 40K arm v 15% in 120K arm, P = .58). Patients randomly assigned to the 40K arm were more likely to have a ≥ 2 or ≥ 3 g/dL hemoglobin (Hb) increment, were more likely to have a drug dose held because of high Hb, and had higher mean end-of-study Hb levels. Toxicities, including thromboembolism, and overall survival were similar. Patients in the 40K arm had a higher global quality of life (QOL) at baseline for unclear reasons, whereas patients in the 120K arm had a greater global QOL improvement during the study, so end-of-study QOL was equivalent.ConclusionAfter three weekly doses of epoetin alfa 40,000 U, a dose of 120,000 U can be administered safely once every 3 weeks without increasing transfusion needs or sacrificing QOL. The Hb increment is somewhat greater with continued weekly epoetin alfa. Lack of blinding as a result of different treatment schedules may have confounded results.

scholarly journals Apixaban, Dalteparin, in Active Cancer Associated Venous Thromboembolism, the ADAM VTE Trial

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 421-421 ◽  
Author(s):  
Robert D. McBane ◽  
Waldemar E. Wysokinski ◽  
Jennifer Le-Rademacher ◽  
Aneel A. Ashrani ◽  
Alfonso J Tafur ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Conflicts Of Interest ◽  
Breast Cancers ◽  
Primary Analysis ◽  
Patients With Cancer ◽  
Cancer Types ◽  
To Receive

Abstract Background: Currently, low molecular weight heparin is the guideline endorsed treatment of patients with cancer associated venous thromboembolism (VTE). While apixaban is approved for the treatment of acute VTE, there are limited data supporting its use in cancer patients. Methods: Patients with cancer associated acute VTE were randomly assigned to receive either apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily or subcutaneous dalteparin (200 IU/kg for 1 month followed by 150 IU/kg once daily) for 6 months. The primary outcome was major bleeding. Secondary outcomes included VTE recurrence and a composite of major plus clinically relevant non-major bleeding. Results: Of the 300 patients who underwent randomization, 287 were included in the primary analysis. Of these, metastatic disease was present in 65.5% of subjects and 74% were receiving concurrent systemic cancer therapy. Colorectal, lung, pancreas, and breast cancers were the four most prevalent cancer types. Major bleeding occurred in 0 of the 142 patients (0%) in the apixaban group as compared with 3 of the 145 patients (2.1%) in the dalteparin group (p=0.9956). Recurrent VTE occurred in 5 patients (3.4%) in the apixaban group and 20 patients (14.1%) in the dalteparin group (difference in risk -10.7 percentage points) with a Hazard Ratio (HR) 0.26, (95% CI, 0.09 - 0.80, p = 0.0182). Major plus clinically relevant non-major bleeding were similar at 9% for both groups. There were no mortality differences comparing apixaban (15.9%) and dalteparin (10.6%) groups at 6 months (HR 1.36, 95% CI 0.79 - 2.35). Monthly quality of life surveys favored apixaban therapy for many measures including: concern for excess bruising, stress, irritation, burden of delivery, and overall satisfaction with anticoagulant therapy (p<0.05). Monthly bruising questionnaire favored apixaban at each interval (p<0.002). Conclusions: Oral apixaban therapy was associated with very low rates of bleeding and significantly lower VTE recurrence with superior quality of life outcome measures compared to parenteral dalteparin in the treatment of cancer associated VTE. These data support the clinical utility of apixaban for the acute treatment of VTE in this patient population. Table. Table. Disclosures No relevant conflicts of interest to declare.

scholarly journals Racial Differences in Treatment Dose Intensity Among Patients with Diffuse Large B-Cell Lymphoma: Analysis of the Veterans Health Administration (VHA) National Database

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 554-554
Author(s):  
Peter A Riedell ◽  
Kristen M. Sanfilippo ◽  
Katiuscia O'Brian ◽  
Weijian Liu ◽  
Suhong Luo ◽  
...  
Keyword(s):  
Cell Lymphoma ◽  
Univariate Analysis ◽  
Multivariate Logistic Regression Analysis ◽  
Dose Intensity ◽  
B Cell Lymphoma ◽  
Multivariate Logistic Regression ◽  
Factors Associated ◽  
Large B Cell Lymphoma ◽  
Treatment Dose ◽  
To Receive

Abstract Introduction: Previous studies in diffuse large B-cell lymphoma (DLBCL) have demonstrated that higher treatment dose intensity is associated with improved survival. Race-based differences in dose intensity may contribute to outcome differences. In order to better understand the relationship between dose intensity and race, we performed a retrospective analysis of veterans examining demographic and clinical factors associated with dose intensity in patients with DLBCL. Methods: Patients diagnosed with DLBCL between October 1, 1998 and December 31, 2008 and treated within the VHA system with CHOP or CHOP-like regimens (+/- rituximab) were identified in the VA Central Cancer Registry. Data on age, sex, race, stage, lactate dehydrogenase (LDH), B-symptoms, body mass index, HIV status, co-morbidities, medications, and socioeconomic status were obtained. Average relative dose intensity (ARDI) was calculated for the use of cyclophosphamide and doxorubicin in patients who received CHOP chemotherapy. Univariate analysis was performed to explore demographic and clinical characteristics dichotomized by ARDI < or ≥ 80%. Additionally, a multivariate logistic regression analysis was used to identify baseline factors associated with receiving treatment with an ARDI ≥ 80%. Results: 1575 DLBCL patients who received doxorubicin and survived more than 5 months after treatment initiation were identified. On univariate analysis, patients who received ARDI <80% were more likely to be older (66.1 vs 61.2, p=<0.001), have advanced stage disease (58.9% vs 52.7%, p=0.015), have systemic B-symptoms (51.7% vs 45.5%, p=0.002), have more co-morbidities (mean co-morbidity score 2.4 vs 1.7, p=<0.0001), have HIV (7.5% vs 3.3%, p=0.0002), less likely to receive rituximab (73.5% vs 79.1%, p=0.008), and were more likely to be from the lowest estimated household income quartile (25.5% vs 21.8%, p=0.03). While not statistically significant on univariate analysis, patients receiving lower ARDI were slightly more likely to be Black (13.8% vs 10.6%, p=0.053). On multivariate logistic regression analysis, factors associated with reduced odds of receiving treatment with an ARDI ≥ 80% included: Black race, (OR 0.62; 95% CI 0.44 – 0.87), age (OR 0.96; 95% CI 0.95 – 0.97), HIV positive status (OR 0.24; 95% CI 0.14 – 0.40), and presence of B-symptoms (OR 0.74; 95% CI 0.59 – 0.93). Conclusion: After controlling for the other identified variables, Black patients were significantly less likely to receive an ARDI of ≥ 80%. The reasons for this finding are unknown from this analysis. Future efforts to reduce racial outcome disparities in NHL could include efforts to understand the underlying causes of chemotherapy dose reductions and delays in racial minority populations, which were present in the VHA, an equal access healthcare system. Disclosures No relevant conflicts of interest to declare.

Opioids for outpatients with cancer in their last year of life: A nationwide pharmacoepidemiological study

2016 ◽  
Vol 12 (1) ◽  
pp. 25 ◽  
Author(s):  
Siri Brelin, MD ◽  
Olav M. Fredheim, MD, PhD ◽  
Jon H. Loge, MD, PhD ◽  
Svetlana Skurtveit, PhD ◽  
Tom B. Johannesen, MD, PhD ◽  
...  
Keyword(s):  
Odds Ratio ◽  
Prescription Database ◽  
Prescription Data ◽  
Pharmacoepidemiological Study ◽  
Patients With Cancer ◽  
Sociodemographic Data ◽  
Norwegian Prescription Database ◽  
Study Population ◽  
To Receive ◽  
Cancer Diseases

Objective: Opioids are the main pharmacological treatment for moderate-to-severe cancer pain. Few longitudinal studies have examined the prescription prevalence (PP) of opioids to patients with cancer. The aims of the study were to examine 1) changes in the PP of opioids from 2005 to 2009 among outpatients with cancer who were in their last year of life and 2) associations between the PP of opioids and medical and sociodemographic factors.Design: Retrospective, registry-based, national study.Patients: This study used data on all patients with cancer who died 2005-2009, combining the following three complete nationwide registries; prescription data from the Norwegian Prescription Database, data on cancer diseases from the Cancer Registry of Norway, and sociodemographic data from Statistics Norway.Results: The study population consisted of 44,579 adults (mean age 72 years at death, 54 percent males). The opioid PP increased from 74 to 82 percent during the study period. Oxycodone had the highest PP, and increased from 39.8 to 48.5 percent during the period, whereas the PP of morphine declined from 29.0 to 27.3 percent. The PP for fentanyl remained stable at 17 percent. The PP of opioids increased toward death with higher PP during the last 3 months of life compared to previous 3-month periods. Older patients (>60) were less likely to receive opioids, while prostate or pancreatic cancer increased the odds for opioid prescriptions (p < 0.001, Odds ratio [OR] 2.60 and OR 1.98, respectively).Conclusion: The PP increased yearly during the study period. Use of oxycodone increased while that of morphine decreased.

scholarly journals Protocol for ‘Resilient Caregivers’: a randomised trial of a resilience-based intervention for psychologically distressed partner caregivers of patients with cancer

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e048327
Author(s):  
Peter Genter ◽  
Beverley Lim Høeg ◽  
Camilla Jensen Hamre ◽  
Elisabeth Anne Wreford Andersen ◽  
Susanne Oksbjerg Dalton ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Patients With Cancer ◽  
Registration Number ◽  
Resilience Framework ◽  
Reflective Skills ◽  
Written Informed Consent

IntroductionIntimate partners of patients with cancer often experience significant distress, but there is a lack of psychological interventions that specifically target this population. ‘Resilient Caregivers’ is a novel resilience-based intervention for distressed partner cancer caregivers. The intervention was developed according to a resilience framework focusing on meta-reflective skills, coping strategies and value clarification. The aim of this study is to evaluate the effectiveness of this intervention in a randomised trial.Methods and analysisEighty participants will be invited through the Oncology Department at Herlev Hospital, Denmark and randomised to either the intervention or usual care. Participants are eligible if they are partners (married or unmarried) of patients diagnosed with cancer and experience distress (>4 on the distress thermometer). ‘Resilient Caregivers’ consists of seven manualised group sessions (2.5 hours each), focusing on resilience in relation to being a partner caregiver of a patient with cancer. The primary outcome is symptoms of anxiety, while secondary outcomes include distress, depression, quality of life, sleep quality and resilience. Data will be collected at baseline, 3, 6 and 12 months follow-up using validated scales, and analysed using mixed models for repeated measures.Ethics and disseminationThis study will follow the ethical principles in the Declaration of Helsinki and has been reviewed by the Ethics Committee of the Capital Region of Denmark (Journal no. 18055373). Written informed consent will be obtained from all participants. Results will be reported through scientific peer-reviewed journals and relevant conferences.Trial registration numberNCT04610034.

Comparative study of pamidronate disodium and etidronate disodium in the treatment of cancer-related hypercalcemia.

1992 ◽  
Vol 10 (1) ◽  
pp. 134-142 ◽  
Author(s):  
R Gucalp ◽  
P Ritch ◽  
P H Wiernik ◽  
P R Sarma ◽  
A Keller ◽  
...  
Keyword(s):  
Serum Calcium Level ◽  
Treated Group ◽  
Efficacy And Safety ◽  
Female Adult ◽  
Double Blind ◽  
Patients With Cancer ◽  
Etidronate Disodium ◽  
The Mean ◽  
Pamidronate Disodium ◽  
To Receive

PURPOSE This multicenter, double-blind, randomized trial was performed to determine the efficacy and safety of pamidronate disodium (APD) in comparison to etidronate disodium (EHDP) in the treatment of cancer-related hypercalcemia. PATIENTS AND METHODS Sixty-five male and female adult patients with cancer and corrected calcium levels of greater than or equal to 12.0 mg/dL after 24 hours of hydration were randomized to receive either 60 mg APD given as a single 24-hour infusion or 7.5 mg/kg EHDP given as a 2-hour infusion daily for 3 days. RESULTS APD normalized corrected calcium levels in 70% (21 of 30) of patients, whereas EHDP did so in 41% (14 of 34) of patients (P = .026). The mean corrected serum calcium level decreased from 14.6 to 10.5 mg/dL in the APD-treated group and from 13.8 to 11.6 mg/dL in the EHDP-treated group within the first week of treatment. There was no difference in response to APD in patients without versus those with bone metastases (78% v 67%). Both drugs were well tolerated. CONCLUSION This study demonstrated that a single 60-mg infusion of APD is safe and more effective than EHDP given at the dose of 7.5 mg/kg for 3 days in the treatment of cancer-related hypercalcemia.

A randomized controlled trial of the effect of intercessory prayer on the spiritual wellbeing and quality of life of patients with cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20708-e20708
Author(s):  
I. N. Olver ◽  
H. S. Whitford
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Intercessory Prayer ◽  
Spiritual Wellbeing ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
To Receive

e20708 Background: A number of scientific trials assessing the positive impact of intercessory prayer attest to centuries of anecdotal evidence, despite debate of its mechanism. However, little attention has been afforded to patients with cancer and the effect such intervention has on quality of life, including spiritual wellbeing. This study aimed to assess the effect of remote, Christian intercessory prayer on cancer patients’ quality of life, specifically their spiritual wellbeing, including their search for meaning, peace, and faith. Methods: New, consecutive patients with cancer attending an Australian cancer centre, aged 18 years or above, able to read English, and give consent were recruited. With Ethics Committee approval, this prospective, double blinded randomized controlled trial only partially divulged the nature of the study to patients who were informed of the measurements but not the inclusion of randomization to an intervention. Specifically, patients were blindly, randomly allocated to receive distant, intercessory prayer from an established Christian prayer chain (intervention) or not to receive prayer (control). All patients completed the Mental Adjustment to Cancer (MAC) scale and the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) at baseline. The FACIT-Sp was re-administered six months later to assess the primary endpoint, a change in spiritual wellbeing. It was anticipated that 1000 patients were needed (allowing for 20% drop out) to achieve 80% power to detect hypothesized small differences (Cohen's d .20-.50) between groups (alpha = .05). Results: A total of 1003 eligible, consenting patients were accrued between June 2003 and May 2008. Intervention (n = 509) and control (n = 494) groups will be compared across baseline characteristics to identify any pre-existing differences. Between-within subject analyses of covariance (ANCOVAs) will be used to assess whether any differences were evident between groups across measures of spiritual wellbeing and other facets of quality of life. Conclusions: The results of these analyses will be presented. It is hoped this research will provide further empirical support for the biopsychosocialspiritual model of health. No significant financial relationships to disclose.

Rationale for heparin treatment of colon cancer

2000 ◽  
Vol 20 (03) ◽  
pp. 136-142 ◽  
Author(s):  
D. L. Ornstein ◽  
L. R. Zacharski
Keyword(s):  
Clinical Trials ◽  
Substantial Improvement ◽  
Patients With Cancer ◽  
Coagulation Mechanism ◽  
Anticoagulant Drug ◽  
Cancer Outcome ◽  
Meta Analyses ◽  
Improvement In Survival ◽  
Spectrum Of Patients ◽  
To Receive

SummaryIt is widely known that the systemic blood coagulation mechanism is often activated in malignancy, leading to an increased incidence of vascular thromboses in patients with cancer. It is not widely appreciated, however, that products of the coagulation mechanism may also support tumor growth and dissemination. Interest in this approach to cancer therapy has surged recently because of mounting evidence that the familiar anticoagulant drug, heparin, may impede tumor progression. Heparin has the capacity to modify angiogenesis, growth factor and protease activity, immune function, cell proliferation and gene expression in ways that may block malignant dissemination. Clinical trials in which heparin has been administered to a broad spectrum of patients to prevent or treat thrombosis have unexpectedly shown improvement in survival in the subset of patients with malignancy entered to these studies. Meta-analyses of clinical trials comparing unfractionated (UF) versus low molecular weight (LMW) heparin treating venous thromboembolism suggest that there may be substantial improvement in cancer outcome in patients with malignancy randomized to receive LMW heparin. These findings provide a rationale for definitive clinical trials of LMW heparin in cancer, and the results of several such studies that are currently underway are awaited with interest.

Lesson Study dan Implikasinya Terhadap Pembelajaran Berbasis Kurikulum Tingkat Satuan Pendidikan

2016 ◽  
Vol 1 ◽  
pp. 189-196
Author(s):  
Vian Harsution
Keyword(s):  
Learning Environment ◽  
Learning Process ◽  
Lesson Study ◽  
Learning Difficulties ◽  
Learning Needs ◽  
Democratic Leadership ◽  
Entrepreneurial Spirit ◽  
To Receive

Lesson study is a systematic, collaborative, and sustainable method of improving the quality of learning. Lesson study emphasizes the exploration of students’ learning needs; teacher openness towards learning difficulties encountered; the willingness of teachers to receive and provide advice and solutions to the difficulties encountered; and the consistency of the various parties to follow up the suggestions and solutions. Implementation of lesson study involving teachers, principals, and experts in the field of education. Kurikulum tingkat satuan pendidikan or abbreviated KTSP is operational curriculum formulated and implemented by each educational unit. KTSP has the characteristics, namely: giving broad autonomy to the educational unit, involving the community and parent participation, involving the democratic leadership of the principal, and require the support of a working team that is synergistic and transparent. KTSP based on the learning process, needs to be supported by a conducive learning environment and fun to be created by teachers.Teachers and principals in a professional, systematic and collaborative create an atmosphere that fosters independence, tenacity, entrepreneurial spirit, adaptive and proactive nature of the learning process. Thus, the learning needs of students who fulfilled optimally and professional ability of teacher who have increased on an ongoing basis, may usher in success – based learning KTSP. It means that the lesson study provides positive implications for the KTSP – based learning.

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