Sipjeondaebo-tang in patients with cancer with anorexia: a protocol for a pilot, randomised, controlled trial.
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ABSTRACT:
SUBMITTER: Cheon C
PROVIDER: S-EPMC4874172 | biostudies-other | 2016 May
REPOSITORIES: biostudies-other
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Project description:Background:Anorexia occurs in about half of cancer patients and is associated with high mortality rate. However, safe and long-term use of anorexia treatment is still an unmet need. Objective:The purpose of the present study was to examine the feasibility of Sipjeondaebo-tang (Juzen-taiho-to, Shi-Quan-Da-Bu-Tang) for cancer-related anorexia. Methods:A total of 32 participants with cancer anorexia were randomized to either Sipjeondaebo-tang group or placebo group. Participants were given 3 g of Sipjeondaebo-tang or placebo 3 times a day for 4 weeks. The primary outcome was a change in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes included Visual Analogue Scale (VAS) of anorexia, FAACT scale, and laboratory tests. Results:Anorexia and quality of life measured by FAACT and VAS were improved after 4 weeks of Sipjeondaebo-tang treatment. However, there was no significant difference between changes of Sipjeondaebo-tang group and placebo group. Conclusions:In the present study, [corrected] Sipjeondaebo-tang did not show a significant effect on anorexia [corrected]in patients with cancer. Further large-scale studies which compensate for the limitations of this study are needed to assess [corrected] the efficacy. Trial Registration:This trial is registered with ClinicalTrials.gov NCT02468141.
| S-EPMC5758845 | biostudies-literature
Project description:INTRODUCTION:Cancer-related fatigue is a frequent symptom in patients with cancer and one of the most distressing symptoms in patients with breast cancer. Sipjeondaebo-tang (Juzen-taiho-to in Japanese or Shi-Quan-Da-Bu-Tang in Chinese) is a widely used herbal medicine for the treatment of fatigue in Korea, China and Japan. The purpose of the present study is to evaluate the feasibility of Sipjeondaebo-tang for cancer-related fatigue. METHODS AND ANALYSIS:The present study is a randomised, double-blind, placebo-controlled, cross-over study. Forty-eight patients with breast cancer who are indicated for doxorubicin and cyclophosphamide will be recruited. The participants will receive 3?g of Sipjeondaebo-tang or a placebo three times a day for 56?days. The primary outcome measurement is the change in the Brief Fatigue Inventory scores. The secondary outcome measurements include the changes in the Visual Analogue Scale (VAS) of fatigue, and quality of life measured by the European Organization for Research and Treatment of Cancer-QLQ-C30 and QLQ-BR23. VAS of fatigue will be measured on every visit, and other outcomes will be measured on visits 2, 4, 6 and 7. The total study period is 14?weeks. ETHICS AND DISSEMINATION:This study has been approved by the Institutional Review Board of the Catholic Kwandong University International St Mary's Hospital (reference IS16MNSI0011). The results of this study will be published in a peer-reviewed journal and presented at a scientific conference. TRIAL REGISTRATION NUMBER:NCT02858856; Pre-results.
| S-EPMC6042596 | biostudies-literature
Project description:IntroductionAlthough acupuncture has been recommended for alleviating cancer pain by clinical guidelines, the level of the supporting evidence needs to be improved. A pragmatic randomised controlled trial (pRCT) in a hospital setting would provide real-world assessments of the overall clinical effects of acupuncture. This pilot trial aims to explore the feasibility and provide data for sample size calculations for a pRCT evaluating the effectiveness of acupuncture as an adjunctive therapy to routine medical care for cancer pain.Methods and analysisThirty patients with cancer admitted to the oncology department with moderate or severe pain will be recruited. Participants will be randomised at a ratio of 1:1 to the adjunctive acupuncture group or a control group which receives routine pain management without acupuncture. The standardised section of the acupuncture protocol will be developed based on the results of reviews of the literature, recommendations in clinical guidelines and interviews with clinical experts. The acupuncturist will be allowed to tailor the protocol according to the individual situation of each participant. Primary outcomes relevant to the feasibility of conducting a fully powered trial include: numbers and proportions of participants recruited, screened, consented and randomised; numbers and reasons for withdrawals and dropouts; numbers and types of adverse events; feasibility of implementing the trial procedures; evaluation of the comprehensiveness and ease-of-use of the case report form. Secondary outcomes are clinical measurements of the effectiveness of the treatment that are intended for use in the full-scale trial. Analysis of feasibility will be descriptive and pain intensity measures will be analysed using mixed-effects regression.Ethics and disseminationEthics approval was obtained from the Institutional Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (approval no: Z2017-184-01) and RMIT University Human Research Ethics Committee (reference no: 21361). Results will be disseminated in a peer-reviewed journal, and trial participants will be informed via email and/or phone calls.Trial registration numberChiCTR1800017023.
| S-EPMC6629396 | biostudies-literature
Project description:Obesity is a public health concern in many countries due to its increasing prevalence. Euiiyin-tang is an herbal medicine formula often used as a clinical treatment for obesity. It acts to eliminate humidity and purify the blood, the causes of obesity identified by the theoretical framework of Korean medicine. The purpose of this study is to evaluate the efficacy and safety of Euiiyin-tang in treating obesity.This study is a randomised, double-blinded and placebo-controlled, multicentre trial. It has two parallel arms: the Euiiyin-tang group and the placebo group. A total of 160 obese adult women will be enrolled in the trial. The participants will be randomly divided at a 1:1 ratio at visit 2 (baseline). The participants will be administered Euiiyin-tang or placebo for 12 weeks. The primary endpoint is the change in weight occurring between baseline and post-treatment. The secondary outcomes include average weight reduction, changes in body fat, waist and hip circumferences, body mass index, and lipid profile, and the results of questionnaires such as the Korean version of Obesity-related Quality of Life, the Korean version of Eating Attitudes Test, the Social Readjustment Rating Scale, and the Stress Reaction Inventory.The present study will provide research methodologies for evaluating the efficacy and safety of Euiiyin-tang in patients with obesity. In addition, it will provide evidence of correlation between obesity and Sasang constitutional medicine.ClinicalTrials.gov, NCT01724099 . Registered on 2 November 2012.
| S-EPMC5480117 | biostudies-literature
Project description:BackgroundAnorexia nervosa (AN) has amongst the highest mortality rates and the highest treatment costs of any psychiatric disorder. Recently, interest in non-invasive brain stimulation as a novel treatment for AN has grown. These include repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS).MethodsThis double-blind, randomised sham-controlled trial will compare the relative acceptability and efficacy of tDCS and rTMS in people with AN. 70 participants will be randomised to active or sham tDCS, or active or sham rTMS treatment (2:1:2:1 ratio) over an 8-week treatment period. Participants will receive treatment as usual across the study duration. The primary outcomes are change on the Eating Disorder Examination Questionnaire and treatment acceptability. Secondary outcomes will include change in weight, cognition, mood, interpersonal functioning, and quality of life. Following the 8-week assessment, all participants will have the option of receiving an additional 12 weeks of at-home tDCS. A follow-up assessment will be conducted at 20 weeks post treatment.DiscussionResearch into non-invasive brain stimulation as treatments for AN has potential to improve clinical outcomes for patients by comparing the relative efficacy and acceptability of both treatment modalities in the inpatient and at-home setting (i.e., for at-home tDCS) results from this study will provide important information for informing future larger clinical trials of these treatments for AN.Trial registrationClinicalTrials.gov Identifier: NCT05788042.
| S-EPMC10709845 | biostudies-literature
Project description:BACKGROUND:The high prevalence of obesity and non-alcoholic fatty acid disease has become an important public health problem. Daesiho-tang (DST) is an herbal medicine widely used to treat obesity, metabolic syndrome and liver diseases. This pilot study will assess the feasibility of using DST in obese patients with a non-alcoholic fatty liver disease (NAFLD) prior to undertaking a full-scale clinical trial. METHODS/DESIGN:This is a study protocol for a randomised, double-blind, parallel-group, stratified, placebo-controlled pilot trial. We will recruit a total of 60 participants with NAFLD who have a body mass index ??25?kg/m2. They will take either DST or placebo (3?g, three times daily) for 12?weeks with a 4-week follow-up period. The effects of DST will be evaluated by the mean change in body weight as the primary measurement and other secondary parameters (body composition, anthropometric measurements, blood tests, hepatic fat quantification through transient elastography and a physical symptoms questionnaire). Faecal samples will be collected before and after the intervention for a gut microbial analysis. DISCUSSION:In anticipation of conducting further large-scale trials, in this study we will explore the effect of DST on weight loss and obesity-related markers, along with NAFLD-related clinical parameters, in obese patients with NAFLD. Furthermore, it will provide insight into the DST pharmacological mechanism of action through a gut microbiome analysis. TRIAL REGISTRATION:Korean Clinical Trial Registry, KCT0003554. Registered on 25 February 2019.
| S-EPMC6995056 | biostudies-literature
Project description:To address uncertainties prior to conducting a fully powered randomised controlled trial of Morita Therapy plus treatment as usual (TAU) versus TAU alone, or to determine that such a trial is not appropriate and/or feasible.Pilot parallel group randomised controlled feasibility trial.Participants aged ?18 years with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV major depressive disorder, with or without DSM-IV anxiety disorder(s), recruited from general practice record searches in Devon, UK.We randomised participants on a 1:1 basis stratified by symptom severity, concealing allocation using a secure independent web-based system, to receive TAU (control) or 8-12 sessions of Morita Therapy, a Japanese psychological therapy, plus TAU (intervention).Rates of recruitment, retention and treatment adherence; variance and estimated between-group differences in follow-up scores (on the Patient Health Questionnaire 9 (PHQ-9) (depressive symptoms); Generalised Anxiety Disorder Questionnaire 7 (anxiety symptoms); Short Form 36 Health Survey Questionnaire/Work and Social Adjustment Scale (quality of life); Morita Attitudinal Scale for Arugamama (attitudes)) and their correlation with baseline scores.We recruited 68 participants, 5.1% (95% CI 3.4% to 6.6%) of those invited (34 control; 34 intervention); 64/68 (94%; 95% CI 88.3% to 99.7%) provided 4-month follow-up data. Participants had a mean age of 49 years and mean PHQ-9 score of 16.8; 61% were female. Twenty-four of 34 (70.6%) adhered to the minimum treatment dose. The follow-up PHQ-9 (future primary outcome measure) pooled SD was 6.4 (95% CI 5.5 to 7.8); the magnitude of correlation between baseline and follow-up PHQ-9 scores was 0.42 (95% CI 0.19 to 0.61). Of the participants, 66.7% and 30.0% recovered in the intervention and control groups, respectively; 66.7% and 13.3% responded to treatment in the intervention and control groups, respectively.A large-scale trial of Morita Therapy would require 133 participants per group and is feasible with minor modifications to the pilot trial protocol. Morita Therapy shows promise in treating depression and may provide patients with a distinct alternative to current treatments.ISRCTN17544090; Pre-results.
| S-EPMC6089263 | biostudies-other
Project description:Background:Antenatal care is an important public health priority. Women from socially disadvantaged, and culturally and linguistically diverse groups often have difficulties with accessing antenatal care and report more negative experiences with care. Although group antenatal care has been shown in some settings to be effective for improving women's experiences of care and for improving other maternal as well as newborn health outcomes, these outcomes have not been rigorously assessed in the UK. A pilot trial will be conducted to determine the feasibility of, and optimum methods for, testing the effectiveness of group antenatal care in an NHS setting serving populations with high levels of social deprivation and cultural, linguistic and ethnic diversity. Outcomes will inform the protocol for a future full trial. Methods:This protocol outlines an individual-level randomised controlled external pilot trial with integrated process and economic evaluations. The two trial arms will be group care and standard antenatal care. The trial will involve the recruitment of 72 pregnant women across three maternity services within one large NHS Acute Trust. Baseline, outcomes and economic data will be collected via questionnaires completed by the participants at three time points, with the final scheduled for 4 months postnatal. Routine maternity service data will also be collected for outcomes assessment and economic evaluation purposes. Stakeholder interviews will provide insights into the acceptability of research and intervention processes, including the use of interpreters to support women who do not speak English. Pre-agreed criteria have been selected to guide the decision about whether or not to progress to a full trial. Discussion:This pilot trial will determine if it is appropriate to proceed to a full trial of group antenatal care in this setting. If progression is supported, the pilot will provide authoritative high-quality evidence to inform the design and conduct of a trial in this important area that holds significant potential to influence maternity care, outcomes and experience. Trial registration:ISRCTN ISRCTN66925258. Registered 03 April 2017. Retrospectively registered.
| S-EPMC6234800 | biostudies-other
Project description:BackgroundSupporting self-management behaviours is recommended guidance for people with asthma. Preliminary work suggests that a brief, intensive, patient-centred intervention may be successful in supporting people with asthma to participate in life roles and activities they value. We seek to assess the feasibility of undertaking a cluster-randomised controlled trial (cRCT) of a brief, goal-setting intervention delivered in the context of an asthma review consultation.Methods/designA two armed, single-blinded, multi-centre, cluster-randomised controlled feasibility trial will be conducted in UK primary care. Randomisation will take place at the practice level. We aim to recruit a total of 80 primary care patients with active asthma from at least eight practices across two health boards in Scotland (10 patients per practice resulting in ~40 in each arm). Patients in the intervention arm will be asked to complete a novel goal-setting tool immediately prior to an asthma review consultation. This will be used to underpin a focussed discussion about their goals during the asthma review. A tailored management plan will then be negotiated to facilitate achieving their prioritised goals. Patients in the control arm will receive a usual care guideline-based review of asthma. Data on quality of life, asthma control and patient confidence will be collected from both arms at baseline and 3 and 6 months post-intervention. Data on health services resource use will be collected from all patient records 6 months pre- and post-intervention. Semi-structured interviews will be carried out with healthcare staff and a purposive sample of patients to elicit their views and experiences of the trial. The outcomes of interest in this feasibility trial are the ability to recruit patients and healthcare staff, the optimal method of delivering the intervention within routine clinical practice, and acceptability and perceived utility of the intervention among patients and staff.Trial registrationISRCTN18912042.
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Project description:Screening with the guaiac faecal occult blood test (gFOBt) is associated with improved colorectal cancer (CRC) survival, and is offered biennially to men and women aged 60-74 years in England's national Bowel Cancer Screening Programme (BCSP). Uptake of the gFOBt is low, with only 54 % of the eligible population completing the test. Text-message reminders could improve uptake of gFOBt.This paper describes the protocol for a randomised controlled trial, which will examine the effectiveness of a text-message reminder to promote uptake of gFOBt screening in the BCSP. Individual mobile telephone data from 180 general practices in London with existing mobile-health services will be linked to the national BCSP information system via a secure on-line network. All screening-eligible adults registered with a participating practice will be randomised, to receive either usual care (N = 1600) or usual care plus a text-message reminder to self-complete and return their kit eight weeks after their initial invitation (N = 1600). The primary outcome will be the proportion of individuals who return an adequately completed gFOBt kit within 18 weeks of the initial invitation. Differences in uptake between groups will be evaluated using a logistic regression analysis, adjusting for individual-level and area-level socio-demographic variables.This will be the first large-scale randomised trial of a text-message reminder in a national screening programme for CRC. If effective, this study provides a cost-effective means to promote uptake of CRC screening in an organised programme.Current Controlled Trials ISRCTN70904476 (18/09/2015).
| S-EPMC4727285 | biostudies-other