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Claire M. Ervin David S. Reasner Jennifer T. Hanlon Sheri E. Fehnel 《Advances in therapy》2017,34(12):2680-2692
Introduction
To improve understanding of the diabetic gastroparesis (DGP) patient experience and inform the patient-reported outcome measurement strategy for future trials in DGP, qualitative interviews were conducted with participants in a phase 2 clinical trial of a novel DGP treatment.Methods
Trial participants were invited to participate in interviews at both the pretreatment visit (PTV) and the end-of-treatment visit (EOTV). The interviews were conducted by experienced qualitative researchers and followed a semistructured interview guide. The PTV interviews focused on patients’ DGP symptoms and the impact of DGP on their lives, and the EOTV interviews focused on any symptom changes patients experienced during the trial.Results
Of 90 enrolled trial participants, 78 (86.7%) opted to participate in the interview study. Bloating, stomach fullness, upper abdominal pain, vomiting, constipation, and heartburn or reflux were each reported spontaneously by a majority of the 73 PTV interview participants with evaluable data. These patients commonly reported bloating (n = 20), upper abdominal pain (n = 12), and nausea (n = 11) as their most bothersome DGP symptom. Of 51 EOTV interview participants, 44 (86.3%) reported improvement in at least one DGP symptom either spontaneously or when asked about specific symptoms reported during their PTV interview.Conclusion
Bloating, abdominal pain, nausea, constipation, stomach fullness, vomiting, and heartburn were frequently reported by patients as the most bothersome and important-to-treat symptoms. These results support the assessment of these symptoms in future DGP clinical trials, whether for symptom improvement or worsening.Funding
Ironwood Pharmaceuticals.Trial Registration
ClinicalTrials.gov identifier NCT02289846.3.
Luigi Celio Erminio Bonizzoni Filippo De Braud Francesco Agustoni Matti Aapro 《Supportive care in cancer》2016,24(3):1025-1034
Purpose
Data from two noninferiority trials of a dexamethasone-sparing regimen were assessed for the impact of acute nausea and vomiting on delayed outcome in patients undergoing moderately emetogenic chemotherapy (MEC) or anthracycline plus cyclophosphamide (AC).Methods
Chemo-naive patients were randomized to receive palonosetron (0.25 mg IV) plus dexamethasone (8 mg IV) on day 1 of chemotherapy, or the same regimen followed by oral dexamethasone on days 2 and 3 in the MEC (n?=?237) and AC (n?=?380) cohorts. Patients were divided into two groups according to whether or not they experienced vomiting and/or moderate-to-severe nausea during the acute phase (high- and low-risk groups, respectively). Primary efficacy endpoint was the complete protection (CP) against delayed vomiting and moderate-to-severe nausea. Patient’s satisfaction (0–100 mm visual analog scale) was also analyzed.Results
Among the 209 low-risk patients undergoing MEC, delayed CP occurred in 82.9 % of those who received single-dose dexamethasone and 89.8 % of those who received 3-day dexamethasone (P?=?0.165). Of the 271 low-risk patients undergoing AC, CP was achieved in 71.7 % of those treated with single-dose dexamethasone and 84.2 % treated with 3-day dexamethasone (P?=?0.019). In spite of these observations, the patient satisfaction data was not influenced by dexamethasone regimen. In both cohorts, occurrence of acute vomiting or moderate-to-severe nausea was the key independent-predictor for delayed vomiting or nausea, respectively.Conclusions
The dexamethasone-sparing regimen provides adequate delayed protection in patients undergoing MEC who are at low risk for delayed symptoms, and can still be discussed for low-risk AC patients as the daily difference in control is modest. Additional dexamethasone doses can be customized on the basis of occurrence or absence of acute symptoms in the first cycle of MEC and even AC.4.
Ala’ S Aburub B. Gagnon A. M. Rodríguez Nancy E. Mayo 《Supportive care in cancer》2016,24(9):3831-3838
Purpose
People with advanced cancer experience different sequelae which have unique effects on quality of life (QOL). The patient-generated index (PGI) is a personalized measure that allows patients to nominate, rate, and value areas that have the most impact on QOL. Fatigue, pain, and aspects of physical function are among the top 10 areas with QOL impact. An area of validation that is lacking for the PGI is the extent to which spontaneously nominated areas of QOL that patients are concerned with, agree with ratings obtained from standard patient reported outcomes (PROs).Methods
Data from 192 patients were used to compare ratings on fatigue, pain, and physical function obtained from PGI to those from standard outcome measures.Results
Within one severity rating, agreement ranged from 32.1 to 76.9 % within the fatigue domain, 34.2 to 95.24 % for pain, and between 84.2 and 94.7 % for physical function. Of the 10 items where the PGI had the highest agreement, 7 came from the RAND-36. At the domain level, people nominating an area scored in the more impaired range on standard measures than people who did not.Conclusion
PGI gives comparable information as do standard measures.Implications for cancer
PGI provides important information to guide clinical care of the patient and also produces a legitimate total score suitable for research.5.
Noor R Bedikian AY Mahoney S Bassett R Kim K Papadopoulos N Hwu WJ Hwu P Homsi J 《Supportive care in cancer》2012,20(10):2583-2588
Background
Treatment of metastatic melanoma with interleukin-2-based biochemotherapy involves administration of a combination of moderately and highly emetogenic chemotherapies over 5 days. Corticosteroids for the prevention of biochemotherapy-induced nausea and vomiting (CINV) are contraindicated because they cause lysis of LAK cells produced in response to interleukin-2. Palonosetron is a long-acting, highly potent, second-generation serotonin receptor antagonist. The recommended dosing schedule of palonosetron for the control of CINV due to biochemotherapy is not known.Methods
In a phase II design, treatment-naïve patients with metastatic melanoma undergoing the first cycle of biochemotherapy were randomized to receive palonosetron 0.25 mg intravenously for CINV prophylaxis on either days 1 and 4 (schedule 1) or days 1, 3, and 5 (schedule 2). All patients received dacarbazine on day 1, cisplatin, vinblastine, and interleukin-2 on days 1–4, and interferon alpha-2b on days 1–5. We evaluated and compared, by palonosetron dosing schedule, the pattern and the severity of CINV during the first 7 days of treatment and the duration of the 21-day cycle as well as the impact on daily function with the Functional Living Index—Emesis.Results
Thirty patients (median age 53 years) were enrolled. Eighteen (60%) were men. A consistent trend of a better control of both nausea and vomiting favoring schedule 2 was observed during the first 7 days and throughout the cycle. Significantly more patients experienced nausea on any day during the first 7 days on schedule 1 (mean number of episodes 8.1?±?1.5) than on schedule 2 (mean number of episodes 5.6?±?2.3, p?=?0.028). The impact on daily function was similar between the two groups.Conclusions
Both dosing schedules of palonosetron were tolerated well. Alternate day dosing of palonosetron was more effective in controlling CINV in this patient population.6.
Objective
To compare the safety and estimate the response profile of olanzapine, a second-generation antipsychotic, to haloperidol in the treatment of delirium in the critical care setting.Design
Prospective randomized trialSetting
Tertiary care university affiliated critical care unit.Patients
All admissions to a medical and surgical intensive care unit with a diagnosis of delirium.Interventions
Patients were randomized to receive either enteral olanzapine or haloperidol.Measurements
Patient’s delirium severity and benzodiazepine use were monitored over 5 days after the diagnosis of delirium.Main results
Delirium Index decreased over time in both groups, as did the administered dose of benzodiazepines. Clinical improvement was similar in both treatment arms. No side effects were noted in the olanzapine group, whereas the use of haloperidol was associated with extrapyramidal side effects.Conclusions
Olanzapine is a safe alternative to haloperidol in delirious critical care patients, and may be of particular interest in patients in whom haloperidol is contraindicated.7.
Background
There is growing public and legislative body support for the medical use of cannabis products, for example, for chemotherapy-induced nausea and vomiting (CINV), in Germany.Methods
A comprehensive literature search until November 2015 was conducted in MEDLINE, DARE and Cochrane libraries for systematic reviews of randomized controlled trials (RCTs) comparing herbal or pharmaceutical cannabinoids (CB) versus placebo or conventional antiemetics for CINV. Outcomes were reduction of CINV for efficacy, drop-out rates due to adverse events for tolerability, and serious adverse events for safety. The methodology quality of the systematic reviews was evaluated by the tool assessment of multiple systematic reviews (AMSTAR).Results
Six systematic reviews of RCTs included the pharmaceutical CBs dronabinol, levonantradol, and nabilone or whole plant extract (e.g., nabiximol) compared with placebo or conventional antiemetics. There was moderate quality evidence on the efficacy of CBs compared to placebo and conventional antiemetics for CINV. There was moderate quality evidence that pharmaceutical CBs were less tolerated and less safe than placebo and conventional antiemetics in CINV. One RCT examining whole plant extract was included into the systematic reviews. No RCT was found comparing CBs with neurokinine?1 receptor antagonists.Conclusions
With safe and effective antiemetics available, CBs cannot be recommended as first- or second-line therapy for CINV. Some guidelines recommend pharmaceutical CBs as third-line treatment in the management of breakthrough nausea and vomiting. Due to the lack of RCT data and safety concerns, herbal cannabis cannot be recommended for CINV.8.
Julie Vanbockstael Elodie Coquan Sophie Gouerant Djelila Allouache Audrey Faveyrial Sabine Noal Corinne Delcambre Marie-Pierre Galais Jean-François Héron Anne-Charlotte Lefebvre Emmanuel Sevin Ioana Hrab Florence Polycarpe Michel André Laure Kaluzinski Radj Gervais Katharina Gunzer Brigitte Vié Gilles Saucier Noëmie Lemenand Jean-Michel Grellard Bénédicte Clarisse Audrey Emmanuelle Dugué Florence Joly 《Supportive care in cancer》2016,24(3):1131-1138
Purpose
Chemotherapy-induced nausea and vomiting (CINV) still remain frequent. The procedure for announcing the diagnosis (PAD) was an emblematic measure of the first French Plan Cancer aiming at providing patients with time to listen, information after cancer diagnosis, and discussion on treatments and their side effects. We aimed at assessing the risk factors of CINV, focusing on patients’ satisfaction with the PAD.Methods
This prospective multicentre study assessed the frequency and intensity of CINV among chemonaïve patients during the first cycle of treatment. CINV was defined by ≥1 emetic episode or reported nausea intensity ≥3 on a 0–10 scale. Multivariate analysis was used to identify factors related to global CINV onset including satisfaction with the PAD (satisfaction score ≥the median on a 0–10 scale).Results
Data from 291 patients (women, 85.2 %; mean age, 57 years) were analyzed. Most patients (69.4 %) received highly emetogenic chemotherapy regimens and 77.7 % received antiemetic drugs consistent with international guidelines. Acute, delayed and overall CINV were experienced by 40.4, 34.8 and 52.4 % of patients, respectively. Sixty-seven per cent of patients were satisfied with the PAD. No relation was noted between PAD satisfaction and CINV onset. The nausea and vomiting dimension of the QLQ-C30 questionnaire before chemotherapy (OR 3.62), motion sickness history (OR 2.73), highly emetogenic CT (OR 2.73), anxiety (OR 1.99) and younger age (OR 1.96) were independent predictive factors.Conclusions
Although patients were mostly satisfied with the PAD, half of them experienced CINV. A state of anxiety could be identified during the PAD to be managed.9.
Objectives
The aim of this study was to compare quality of life and symptoms between breast cancer survivors who have developed and undergone treatment for chronic lymphedema with those who have not developed lymphedema.Patients and methods
The cross-sectional, mixed-methods design included 64 breast cancer survivors with lymphedema and 64 breast cancer survivors without lymphedema. Variables assessed quantitatively included sociodemographic information, medical data, body mass index (BMI), arm extracellular fluid volume, quality of life (QOL), and physical and emotional symptoms. For the qualitative component, individuals with lymphedema responded in writing to the question: During the past week what other difficulties have you experienced because of your lymphedema?Results
Compared with those without lymphedema, breast cancer survivors with lymphedema reported poorer QOL. A symptom cluster that included alteration in limb sensation, loss of confidence in body, decreased physical activity, fatigue, and psychological distress was identified. Perception of limb size influenced the cumulative symptom experience more than objective arm volume. Qualitative data revealed multiple QOL, physical health, and psychological concerns. BMI correlated with multiple outcomes.Conclusions
Findings suggest that current lymphedema treatments, although beneficial, may not provide complete relief of symptoms associated with lymphedema and complementary interventions are needed. The poorer QOL in breast cancer survivors with lymphedema may relate to the presence of an untreated symptom cluster.10.
Background
The relationship between life stressors, coping and affective disorder is interesting when predicting onset of a affective disorder and relapse of mood episodes.Methods
A litteratur review of cross-sectional and longitudinal studies concerning coping and affective disorder in adults including a Medline and Embase search was conducted.Results
11 cross-sectional studies and 17 longitudinal studies concerning affective disorder and coping were found, among these, two studies include patients with bipolar disorder exclusively. Only four studies elucidate whether emotion-oriented and/or avoidance coping styles are associated with a higher risk of developing affective disorder, so this hypothesis remains unclear. Most studies shows that emotion-oriented and avoidance coping strategies are associated with relapse of depressive episodes. Conversely, problem-focused and task-oriented coping seem to be associated with a good outcome.Conclusion
There is a gap between coping theory and clinical use of coping and the clinical relevance of coping is, though promising, still unclear. In future research it is recommended to concentrate on development of a semi-structured interview combining coping style, life events and personality traits.11.
Maneesh Gupta 《Clin Pract Epidemiol Ment Health》2007,3(1):12
Background
Quetiapine causes less prolactin elevation and/or galactorrhoea than other atypical antipsychotics.Case Presentation
Ms AB had galactorrhoea and raised prolactin levels at only 100 mg of quetiapine daily.Conclusion
Low dose quetiapine can also cause galactorrhoea.12.
Purpose of Review
Marijuana has been used both medicinally and recreationally since ancient times and interest in its compounds for pain relief has increased in recent years. The identification of our own intrinsic, endocannabinoid system has laid the foundation for further research.Recent Findings
Synthetic cannabinoids are being developed and synthesized from the marijuana plant such as dronabinol and nabilone. The US Food and Drug Administration approved the use of dronabinol and nabilone for chemotherapy-associated nausea and vomiting and HIV (Human Immunodeficiency Virus) wasting. Nabiximols is a cannabis extract that is approved for the treatment of spasticity and intractable pain in Canada and the UK. Further clinical trials are studying the effect of marijuana extracts for seizure disorders.Summary
Phytocannabinoids have been identified as key compounds involved in analgesia and anti-inflammatory effects. Other compounds found in cannabis such as flavonoids and terpenes are also being investigated as to their individual or synergistic effects. This article will review relevant literature regarding medical use of marijuana and cannabinoid pharmaceuticals with an emphasis on pain and headaches.13.
Qian Lu Jin You April Kavanagh Krystal Warmoth Zhiqiang Meng Zhen Chen Kavita D. Chandwani George H. Perkins Jennifer Leigh McQuade Nelamangala V. Raghuram Raghuram Nagarathna Zhongxing Liao Hongasandra Ramarao Nagendra Jiayi Chen Xiaoma Guo Luming Liu Banu Arun Lorenzo Cohen 《Supportive care in cancer》2016,24(9):3775-3782
Objective
It has been speculated that cancer survivors in Asia may have lower quality of life (QOL) compared with their Western counterparts. However, no studies have made international comparisons in QOL using a comprehensive measure. This study aimed to compare Chinese breast cancer survivors’ QOL with US counterparts and examine if demographic and medical factors were associated with QOL across groups.Method
The sample consisted of 159 breast cancer patients (97 Chinese and 62 American) who completed the Functional Assessment for Cancer Therapy Breast Cancer (FACT-B) scale before the start of radiotherapy in Shanghai, China and Houston, USA.Results
Higher income was associated with higher QOL total scores in both Chinese and American cancer patients, but QOL was not significantly associated with other factors including age, education, disease stage, mastectomy, and chemotherapy. Consistent with hypotheses, compared to their US counterparts, Chinese breast cancer survivors reported lower QOL and all four subdimensions including functional well-being (FWB), physical well-being (PWB), emotional well-being (EWB), and social well-being (SWB); they also reported more breast cancer-specific concerns (BCS). Differences were also clinically significant for Functional Assessment for Cancer Therapy General (FACT-G) scale total scores and the FWB subscale. After controlling for demographic and medical covariates, these differences remained except for the SWB and BCS. Furthermore, Chinese breast cancer survivors receiving chemotherapy reported significantly lower FACT-G scores than those who did not, but this difference did not emerge among US breast cancer survivors.Discussion
Chinese breast cancer survivors reported poorer QOL on multiple domains compared to US women. Findings indicate that better strategies are needed to help improve the QOL of Chinese breast cancer survivors, especially those who underwent chemotherapy.14.
Aims
Create an educational program in chronic pain (EPCP).Material and methods
We used a four-step process to create the EPCP tailored to patient’s needs.Results
Five groups of patients can benefit from the program annually. Based on their own assessment, patients stated that their knowledge of chronic pain improved between 2.8 to 24%. The satisfaction with the EPCP was 8.67/10.Conclusion
Our EPCP helps patients gain and maintain the skills they need to best manage their lives with a chronic pain.16.
George Dranitsaris Sasha Mazzarello Stephanie Smith Lisa Vandermeer Nathaniel Bouganim Mark Clemons 《Supportive care in cancer》2016,24(4):1563-1569
Purpose
The objective of this exploratory analysis was to determine if individual patient risk factors could be used to optimize chemotherapy-induced nausea and vomiting (CINV).Methods
Through validated risk prediction models which quantify patient risk factors, 152 patients with early-stage breast cancer scheduled to received adjuvant anthracycline-based chemotherapy were categorized as being at low (level 0) or high-risk (level 1) for CINV. Prior to the first cycle of chemotherapy, low-risk patients received ondansetron and dexamethasone, while high-risk level 1 patients also received aprepitant. For subsequent cycles, patients who experienced CINV had their antiemetics changed in a stepwise manner to level 2 (extended-duration dexamethasone) or level 3 (extended-duration dexamethasone and low-dose olanzapine).Results
The study enrolled 152 patients who received 484 cycles of chemotherapy. Forty patient cycles were classified as low risk (level 0) compared to 201, 162 and 81 that were classified as high-risk levels 1, 2 and 3, respectively. Complete control of acute and delayed vomiting was comparable and was achieved in over 85 % of patients across all risk levels (p = 0.56 and p = 0.99). In contrast, complete control of acute and delayed nausea was reduced in risk levels 1 to 3 compared to level 0 (acute = 51.2, 58.0, 45.7 vs. 70.0 %; p = 0.013)—(delayed = 32.8, 45.7, 34.6 vs. 62.5 %; p < 0.001).Conclusions
Despite the addition of aprepitant, extended-duration dexamethasone and olanzapine, patients at high risk for CINV due to personal risk factors failed to achieve good nausea control.17.
Karin Jordan David G. Warr Axel Hinke Linda Sun Paul J. Hesketh 《Supportive care in cancer》2016,24(5):1941-1954
Purpose
This meta-analysis was performed to evaluate the efficacy of neurokinin-1 receptor antagonists (NK1RAs) for the prevention of chemotherapy-induced nausea and vomiting (CINV) across different categories of chemotherapeutic emetogenicity.Methods
A systematic review of MEDLINE (via PubMed) and OVID databases, plus major oncology conferences, identified randomized, controlled trials evaluating NK1RAs in combination with a 5-HT3 RA plus a glucocorticoid for management of CINV. Efficacy end points were no emesis, no nausea, and complete response (CR) rates. Data were analyzed using a random effects model.Results
Twenty-three trials (N = 11,814) were identified. Based on absolute differences (AD) for no emesis (21 %), no nausea (8 %), CR (16 %), and odd ratios (OR) of 2.62, 1.43, and 2.16, respectively, NK1RA regimens provided better CINV protection versus control groups (all p < 0.00001) in patients receiving cisplatin-based highly emetogenic chemotherapy (HEC). In patients receiving anthracycline/cyclophosphamide (AC)-based HEC, respective ADs and ORs were 14, 4, and 11 % and 1.97 (p < 0.0001), 1.17 (p = 0.04), and 1.62 (p < 0.00001). In patients receiving moderately emetogenic chemotherapy (3 trials), no statistically significant benefit of NK1RAs was found; however, positive trends were detected for CR and no emesis. NK1RAs were effective for CINV prevention in a small number of studies using high-dose chemotherapy as conditioning prior to stem cell transplant and cisplatin-based multiple-day chemotherapy (MDC).Conclusions
This meta-analysis demonstrated the efficacy of NK1RA in preventing vomiting in patients receiving HEC (including AC), with smaller effects on prevention of nausea. Efficacy is also seen with high-dose chemotherapy and cisplatin-based MDC.18.
Anna Theodorou-Kanakari Spyridon Karampitianis Vasiliki Karageorgou Eleni Kampourelli Efstathios Kapasakis Panagiotis Theodossiadis Irini Chatziralli 《Advances in therapy》2018,35(10):1510-1518
Introduction
The purpose of this review is to present the current and emerging treatment alternatives for Leber’s hereditary optic neuropathy (LHON), emphasizing the most recent use of idebenone and stem cells or gene therapy.Methods
A comprehensive literature review was performed at the PubMed database regarding the various treatment modalities for LHON.Results
Treatment modalities for LHON include nutritional supplements, activators of mitochondrial biogenesis, brimonidine, and symptomatic and supportive treatment, but nowadays attention is being paid to idebenone and gene therapy or stem cells.Conclusion
The treatment of LHON remains challenging, given the nature of the disease and its prognosis.19.
Background
In the context of improving perioperative pain management and shortening hospital stays, potent oral analgesics, such as slow release opioids, are gaining increasingly in importance.Objective
The aim of this study was to compare the use and effectiveness of different opioids in postoperative pain treatment in Germany.Materials and methods
Using data from the QUIPS database, the records of 5249 patients were evaluated. The total study population was divided into four groups: group 1 (10?mg oxycodone with or without naloxone 5?mg), group 2 (20?mg oxycodone with or without naloxone 10?mg), group 3 (piritramide) and group 4 (tramadol). Maximum pain intensity, pain-related interference with sleep and respiration, vomiting, postoperative fatigue, desire for more pain treatment and satisfaction with pain management were evaluated.Results and discussion
The differences in pain intensity were statistically significant between groups. Patients with piritramide reported more pain, more interference with sleep and respiration and more fatigue compared to those from the other groups. In the group with 10?mg oxycodone, the desire for additional pain medication was the lowest. Postoperative vomiting and satisfaction with pain management differed significantly between the four groups. Procedure-specific analysis has shown that differences between sub-groups were also significant following cholecystectomy and total knee arthroplasty.Conclusions
In summary, our findings suggest that postoperative pain treatment with slow release oral oxycodone does not show disadvantages compared to tramadol or piritramide with regard to pain-related impairments and opioid-induced side effects. This hypothesis needs to be further analyzed in controlled studies.20.
Leonhard Gruber Hannes Gruber Tanja Djurdjevic Peter Schullian Alexander Loizides 《Journal of Medical Ultrasonics》2016,43(3):413-420