scholarly journals How is best supportive care provided in clinical trials for patients with advanced cancer? A review of registered protocols of clinical trials

2019 ◽  
Vol 27 (2) ◽  
Author(s):  
Á. Sanz Rubiales ◽  
M. E. Sánchez-Gutiérrez ◽  
L. A. Flores Pérez ◽  
M. L. Del Valle Ribero
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Best Supportive Care ◽  
Phase Iii ◽  
Consensus Statements ◽  
Definition Of ◽  
Randomised Controlled ◽  
Clinical Trials Registry

Background In 2012, 11 standards describing best supportive care (bsc) in clinical trials in advanced cancer were defined through consensus statements. The consensus included 15 key components. Our objective was to analyze whether clinical trials that involved patients with advanced cancer and that included bsc in at least 1 arm met the standards and contained the key components. Methods We reviewed clinical trials registered in ClinicalTrials.gov, the isrctn (International Standard Randomised Controlled Trial Number) registry, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform for 2012–2018. We selected only phase iii studies in patients with advanced cancer that included bsc in at least 1 arm. We describe the characteristics of the trials, together with the definition and components of bsc. We analyzed how the trials met the standards and adopted the key components of bsc. Results Of 193 trials retrieved, only 64 met the inclusion criteria; 36 of those trials (56%) had no definition of bsc. Less than 7% of the trials included even 3 of the 8 bsc standards that were defined to be included in the design of trials. Furthermore, trials mentioned only 5 of the 15 key components that the consensus defined to be fundamental, with symptom management appearing in 22% of trials and the other 4 components appearing in less than 8%. Summary Most clinical trials registered during 2012–2018 that involved patients with cancer and an arm with bsc did not define the bsc concept. Hence, the design of those trials does not meet the consensus recommendations.

Consensus-based standards for best supportive care in clinical trials in advanced cancer

2012 ◽  
Vol 13 (2) ◽  
pp. e77-e82 ◽  
Author(s):  
S Yousuf Zafar ◽  
David C Currow ◽  
Nathan Cherny ◽  
Florian Strasser ◽  
Robin Fowler ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Advanced Cancer ◽  
Best Supportive Care

Is best supportive care really best supportive care?

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9639-9639
Author(s):  
R. Lee ◽  
J. Von Roenn
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Palliative Medicine ◽  
Randomized Clinical Trials ◽  
Best Supportive Care ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Average Survival ◽  
Cancer Types ◽  
Definition Of

9639 Background: With the growth of palliative medicine over the past decade, the paradigm of supportive care has evolved to create new standards for cancer patients. The aim of this study was to define “best supportive care” (BSC) during clinical trials of advanced solid tumors. Methods: Systematic review of the literature using Medline and the Cochrane Central Register of Controlled Trials databases. These were searched for randomized controlled trials in which anticancer therapy was compared with a BSC only arm. Results: A total of 43 studies met our inclusion criteria (publication dates, 1980–2008) with the following cancer types: 22 lung cancer, 6 colorectal, 6 pancreas, 2 gastric, and 7 other cancer types. Thirty-eight studies (88%) provided some definition of supportive care and sixteen studies (37%) used the term BSC. The average survival across treatment arms was 27.5 weeks. All but one study described the use of palliative therapies at the discretion of the treating physician without standardization. Over half of all studies (56%) specifically mentioned analgesics and radiotherapy (RT) for pain control. Other specific interventions listed were steroids (14), antibiotics (10), psychological support (10), nutritional support (9), blood transfusions (8), anti-emetics (6), and anti-depressant or anxiolytic medications (3). One-third of trials (15) reported an equivalent clinical evaluation schedule for both the BSC and treatment arms. Quality of life (QoL) was measured with a validated instrument (e.g., QLQ-30) in 55% of trials and 37% compared the utilization of at least one palliative treatment between groups. Trials using the term BSC were more likely to provide multidisciplinary therapy beyond RT and analgesics (50% vs. 19%; p<0.05). Conclusions: The management of subjects in a BSC arm of clinical trials are highly variable. Overall, the trials compare treatment versus no treatment as subjects in the BSC group likely did not receive care according to current palliative medicine standards. Future randomized clinical trials with a BSC arm should provide a comprehensive, multidisciplinary approach that is consistent with practice guidelines. A standardized BSC approach developed with palliative medicine specialists is warranted for further study. No significant financial relationships to disclose.

Resistance training in advanced cancer: a phase II safety and feasibility trial—home versus hospital

2020 ◽  
pp. bmjspcare-2020-002230
Author(s):  
Catarina Ribeiro ◽  
Rui Santos ◽  
Pedro Correia ◽  
Matthew Maddocks ◽  
Barbara Gomes
Keyword(s):  
Resistance Training ◽  
Advanced Cancer ◽  
Phase Ii ◽  
Controlled Trial ◽  
Phase Iii ◽  
Feasibility Trial ◽  
Home Intervention ◽  
Randomised Controlled ◽  
Training Programmes ◽  
At Home

BackgroundResistance training (RT) is an effective way to increase muscle mass but little is known about its role to prevent sarcopenia in advanced cancer. Furthermore, the preferred setting for this training is not known. Considering home is frequently the place of care and death preferred by cancer patients, it is important to find out whether this would also be the best training setting as opposed to the most common one, hospital.ObjectivesWe aimed to test if RT at home and in hospital is feasible (primary outcome) and safe in advanced cancer, with a view to inform a phase III trial.MethodsPhase II randomised controlled trial including adults (≥18 years) with incurable solid tumours, randomised into one of three arms: (1) supervised RT at home; (2) supervised RT in hospital; (3) standard care with information leaflet. Both training programmes were similar, ran one-to-one with therapists and planned to last 12 weeks (three sessions/week). Feasibility included adherence (proportion of completed sessions) and acceptability (proportion of completed exercises), compared using Fisher’s test.ResultsWe included 15 patients (53% men, median age 68), 5 per arm. The home intervention had higher adherence (49% vs 9% in hospital; p<0.001). Acceptability was similar (93% in home and 95% in hospital; p=0.179). No adverse events were recorded.ConclusionsRT is a safe intervention, more feasible at home than in hospital in advanced cancer. Ways to increase adherence to the home intervention could further improve its potential benefit.Trial registration numberNCT02930876.

scholarly journals Lifestyle InterVention IN Gestational diabetes (LIVING) in India, Bangladesh and Sri Lanka: protocol for process evaluation of a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e037774
Author(s):  
Janani Shanthosh ◽  
Deksha Kapoor ◽  
Lakshmi K Josyula ◽  
Anushka Patel ◽  
Yashdeep Gupta ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Clinical Trials ◽  
Sri Lanka ◽  
Gestational Diabetes ◽  
Controlled Trial ◽  
Evaluation Framework ◽  
New Delhi ◽  
Medical College ◽  
Randomised Controlled ◽  
Clinical Trials Registry

IntroductionThe development of type 2 diabetes mellitus disproportionately affects South Asian women with prior gestational diabetes mellitus (GDM). The Lifestyle InterVention IN Gestational diabetes (LIVING) Study is a randomised controlled trial of a low-intensity lifestyle modification programme tailored to women with previous GDM, in India, Bangladesh and Sri Lanka, aimed at preventing diabetes/pre-diabetes. The aim of this process evaluation is to understand what worked, and why, during the LIVING intervention implementation, and to provide additional data that will assist in the interpretation of the LIVING Study results. The findings will also inform future scale-up efforts if the intervention is found to be effective.Methods and analysisThe Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) methodological approach informed the evaluation framework. Michie’s Behaviour Change Theory and Normalisation Process Theory were used to guide the design of our qualitative evaluation tools within the overall RE-AIM evaluation framework. Mixed methods including qualitative interviews, focus groups and quantitative analyses will be used to evaluate the intervention from the perspectives of the women receiving the intervention, facilitators, site investigators and project management staff. The evaluation will use evaluation datasets, administratively collected process data accessed during monitoring visits, check lists and logs, quantitative participant evaluation surveys, semistructured interviews and focus group discussions. Interview participants will be recruited using maximum variation purposive sampling. We will undertake thematic analysis of all qualitative data, conducted contemporaneously with data collection until thematic saturation has been achieved. To triangulate data, the analysis team will engage in constant iterative comparison among data from various stakeholders.Ethics and disseminationEthics approval has been obtained from the respective human research ethics committees of the All India Institute of Medical Sciences, New Delhi, India; University of Sydney, New South Wales, Australia; and site-specific approval at each local site in the three countries: India, Bangladesh and Sri Lanka. This includes approvals from the Institutional Ethics Committee at King Edwards Memorial Hospital, Maharaja Agrasen Hospital, Centre for Disease Control New Delhi, Goa Medical College, Jawaharlal Institute of Postgraduate Medical Education and Research, Madras Diabetes Research Foundation, Christian Medical College Vellore, Fernandez Hospital Foundation, Castle Street Hospital for Women, University of Kelaniya, Topiwala National Medical College and BYL Nair Charitable Hospital, Birdem General Hospital and the International Centre for Diarrhoeal Disease Research. Findings will be documented in academic publications, presentations at scientific meetings and stakeholder workshops.Trial registration numbersClinical Trials Registry of India (CTRI/2017/06/008744); Sri Lanka Clinical Trials Registry (SLCTR/2017/001) and ClinicalTrials.gov Registry (NCT03305939); Pre-results.

scholarly journals A randomised, double blind, placebo-controlled trial of megestrol acetate or dexamethasone in treating symptomatic anorexia in people with advanced cancer

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
David C. Currow ◽  
Paul Glare ◽  
Sandra Louw ◽  
Peter Martin ◽  
Katherine Clark ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Rating Scale ◽  
Controlled Trial ◽  
Performance Status ◽  
Numeric Rating Scale ◽  
Megestrol Acetate ◽  
Phase Iii ◽  
Fixed Dose ◽  
Double Blind ◽  
Clinical Trials Registry

AbstractThis multi-site, double blind, parallel arm, fixed dose, randomised placebo controlled phase III study compared megestrol acetate 480 mg/day with dexamethasone 4 mg/day for their net effects on appetite in people with cancer anorexia. Patients with advanced cancer and anorexia for ≥ 2 weeks with a score ≤ 4 (0–10 numeric rating scale (NRS) 0 = no appetite, 10 = best possible appetite) were recruited. Participants received megestrol 480 mg or dexamethasone 4 mg or placebo daily for up to 4 weeks. Primary outcomes were at day 7. Responders were defined as having a ≥ 25% improvement in NRS over baseline. There were 190 people randomised (megestrol acetate n = 61; dexamethasone n = 67, placebo n = 62). At week 1 (primary endpoint), 79·3% in the megestrol group, 65·5% in the dexamethasone group and 58·5% in the placebo group (p = 0.067) were responders. No differences in performance status or quality of life were reported. Treatment emergent adverse events were frequent (90·4% of participants), and included altered mood and insomnia. Hyperglycemia and deep vein thromboses were more frequent when on dexamethasone than the other two arms. There was no difference in groups between the three arms, with no benefit seen over placebo with anorexia improving in all arms.Trail registration: The trial was registered on 19/08/2008 with the Australian New Zealand Clinical Trials Registry (ACTRN12608000405314).

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