Does hair curl variation influence the efficacy of scalp cooling in the prevention of chemotherapy-induced alopecia in breast cancer patients? A randomised pilot trial

Background: Scalp cooling is reported to reduce Chemotherapy-induced alopecia (CIA).Aim: To compare the efficacy of scalp cooling for straight versus curly hair in a pilot trail.Setting: A radiation oncology breast cancel clinic.Methods: This 20-month randomised controlled trial recruited females (18–65 years) to receive chemotherapy (Adriamycin or Epirubicin and Cyclophosphamide followed by Paclitaxel) with or without scalp cooling. Outcomes were percentage alopecia (Severity ALopecia Tool) by hair curvature and treatment retention.Results: Forty eight patients (24 per group) were randomised; four in each group withdrew before first study visit and photographs of three in the cooling group could not be found for assessment. Thus 77% constituted the intention-to-treat population (17 cooling vs. 20 control). Agreement on alopecia severity was good overall (intra-class correlation coefficient [ICC] = 0.94; 95% confidence interval [CI]: 0.85–0.97) and at six of seven time points. Overall, cooling significantly reduced CIA, relative to no-cooling (58.15 ± 28.46 vs. 37.29 ± 20.52; p = 0.0167); however, percentage alopecia was cosmetically significant. There was no difference in CIA between cooling participants with straight (n = 8) versus curly hair (n = 9), (p = 0.0740).The number of patients completing the various cycles of chemotherapy declined from 77.1% at cycle 1 to 18.8% at cycle 7 for the whole study, and from 100% each to 17.6% and 30.0% for cooling and control groups, respectively (p = 0.451).Conclusion: This study suggests that hair curvature has no significant impact on the efficacy of scalp cooling to reduce CIA, however, this requires confirmation.

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Effectiveness of a Fortified Drink in Improving B Vitamin Biomarkers in Older Adults: A Controlled Intervention Trial

10.21203/rs.3.rs-757573/v1 ◽

2021 ◽

Author(s):

Maria Heffernan ◽

Leanne C Doherty ◽

Roberta Hack Mendes ◽

Michelle Clarke ◽

Stephanie Hodge ◽

...

Keyword(s):

Older Adults ◽

Controlled Trial ◽

Intervention Strategy ◽

B Vitamins ◽

Double Blind ◽

Intention To Treat ◽

Vitamin Status ◽

Randomised Controlled ◽

B Vitamin ◽

To Receive

Abstract BackgroundOlder adults are reported to have sub-optimal B vitamin status; targeted food-based solutions may help to address this. The objectives of the OptiAge food intervention study were to develop and investigate the effectiveness of a B vitamin-fortified drink in improving B vitamin biomarkers in older Irish adults with a primary outcome of change in B vitamin biomarker concentrations.MethodsA multicentre double-blind randomised controlled trial was performed in University College Dublin and Ulster University. Participants aged > 50 years were recruited following screening for exclusion criteria i.e. taking medications known to interfere with B vitamin metabolism, supplements containing B vitamins, consuming >4 portions of B-vitamin fortified foods per week or diagnosed with gastrointestinal, liver or pulmonary disease. Recruited participants were randomised with gender and centre as factors in the randomisation to receive either B vitamin-fortified or placebo drinks (developed by Smartfish, Norway) daily for 16 weeks.ResultsA total of 95 participants were randomised, of which 81 commenced the trial. Of these, 70 completed - 37 in the active and 33 in the placebo groups. Intention to treat (ITT) analysis of the B vitamins demonstrated a significant improvement in all B vitamins biomarkers in the active compared to placebo groups (p<0.01 for Folate, Vitamin B12, Vitamin B6, and Riboflavin). A significant lowering of plasma homocysteine from 11.9 (10.3-15.1) µmol/L to 10.6 (9.4-13.0) µmol/L (functional marker of B vitamin status) was also observed in response to the active treatment (P<0.001). Similar results were seen in a per-protocol analysis.ConclusionsThe results demonstrate that a B vitamin-fortified drink was effective in optimising B vitamin status, making this a useful intervention strategy to improve B vitamin status in older adults. Trial registration: ISRCTN, ISRCTN61709781. - Retrospectively registered, https://www.isrctn.com/ISRCTN61709781

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The Therapy ‘Pill’: Achieving Treatment Dose Within a Rehabilitation Trial

Brain Impairment ◽

10.1375/brim.9.2.191 ◽

2008 ◽

Vol 9 (2) ◽

pp. 191-197 ◽

Cited By ~ 5

Author(s):

Janice M. Collier ◽

Julie Bernhardt

Keyword(s):

Randomised Controlled Trial ◽

Standard Care ◽

Controlled Trial ◽

Teaching Hospitals ◽

Personal Digital Assistants ◽

Intention To Treat ◽

Trial Quality ◽

Intervention Protocol ◽

Randomised Controlled ◽

And Control

AbstractBackground: Developing high quality clinical trials within rehabilitation research is achievable and should be pursued wherever possible. One of the greatest challenges rehabilitation trialists face is defining experimental and control interventions and ensuring that the intervention dose is delivered as planned. Aim: We describe procedures employed within a pilot randomised controlled trial of a rehabilitation intervention to monitor therapy dose. Method: The trial setting was two acute stroke units in large teaching hospitals in Melbourne, Australia. The design was a randomised controlled trial of very early mobilisation (commenced within 24 hours of stroke onset) plus standard care (VEM) versus standard care alone. Assessors were blinded to group and analysis was intention to treat. All therapy data (both intervention and control) were acquired using personal digital assistants. Monitoring of therapy dose and feedback to trial staff was given 6 months into the trial by a researcher independent of the trial team. Results: Before feedback, therapists were barely meeting intervention protocol minimum targets. Following feedback, compliance with trial protocol was achieved. Conclusion: Monitoring of the therapy dose within a clinical trial is important to achieve trial quality. This article shows how monitoring including feedback leads to improved delivery of the therapy ‘pill’.

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Ear Acupressure for Smoking Cessation: A Randomised Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2013/637073 ◽

2013 ◽

Vol 2013 ◽

pp. 1-8 ◽

Cited By ~ 5

Author(s):

Anthony L. Zhang ◽

Yuan Ming Di ◽

Christopher Worsnop ◽

Brian H. May ◽

Cliff Da Costa ◽

...

Keyword(s):

Smoking Cessation ◽

Primary Outcome ◽

Controlled Trial ◽

Dropout Rate ◽

Efficacy And Safety ◽

Intention To Treat ◽

Exhaled Carbon Monoxide ◽

Randomised Controlled ◽

To Receive ◽

Treat Analysis

This study investigated the efficacy and safety of ear acupressure (EAP) as a stand-alone intervention for smoking cessation and the feasibility of this study design. Adult smokers were randomised to receive EAP specific for smoking cessation (SSEAP) or a nonspecific EAP (NSEAP) intervention which is not typically used for smoking cessation. Participants received 8 weekly treatments and were requested to press the five pellets taped to one ear at least three times daily. Participants were followed up for three months. Primary outcome measures were a 7-day point-prevalence cessation rate confirmed by exhaled carbon monoxide and relief of nicotine withdrawal symptoms (NWS). Intention-to-treat analysis was applied. Forty-three adult smokers were randomly assigned to SSEAP (n=20) or NSEAP (n=23) groups. The dropout rate was high with 19 participants completing the treatments and 12 remaining at followup. One participant from the SSEAP group had confirmed cessation at week 8 and end of followup (5%), but there was no difference between groups for confirmed cessation or NWS. Adverse events were few and minor.

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A Pilot Randomized Controlled Trial of a Partial Meal Replacement Preconception Weight Loss Program for Women with Overweight and Obesity

Nutrients ◽

10.3390/nu13093200 ◽

2021 ◽

Vol 13 (9) ◽

pp. 3200

Author(s):

Roslyn Muirhead ◽

Nathalie Kizirian ◽

Ravin Lal ◽

Kirsten Black ◽

Ann Prys-Davies ◽

...

Keyword(s):

Weight Loss ◽

Gestational Hypertension ◽

Controlled Trial ◽

Pilot Trial ◽

Overweight And Obesity ◽

Dietary Advice ◽

Meal Replacement ◽

Intention To Treat ◽

Randomised Controlled ◽

Meal Replacements

About half of Australian women have a body mass index in the overweight or obese range at the start of pregnancy, with serious consequences including preterm birth, gestational hypertension and diabetes, caesarean section, stillbirth, and childhood obesity. Trials to limit weight gain during pregnancy have had limited success and reducing weight before pregnancy has greater potential to improve outcomes. The PreBabe Pilot study was a randomised controlled pilot trial to assess the feasibility, acceptability and potential weight loss achieved using a commercial online partial meal replacement program, (MR) vs. telephone-based conventional dietary advice, (DA) for pre-conception weight-loss over a 10-week period. Women 18–40 years of age with a BMI ≥ 25 kg/m2 planning pregnancy within the next 6 to 12 months were included in the study. All participants had three clinic visits with a dietitian and one obstetric consultation. In total, 50 women were enrolled in the study between June 2018 and October 2019–26 in MR and 24 in DA. Study retention at the end of 10 week intervention 81% in the MR arm and 75% in the DA arm. In the-intention-to-treat analysis, women using meal replacements lost on average 5.4 ± 3.1% body weight compared to 2.3 ± 4.2% for women receiving conventional advice (p = 0.029). Over 80% of women in the MR arm rated the support received as excellent, compared to 39% in the DA arm (p < 0.001). Women assigned to the MR intervention were more likely to achieve pregnancy within 12 months of the 10 week intervention (57% (12 of 21) women assigned to MR intervention vs. 22% (4 of 18) assigned to the DA group (p = 0.049) became pregnant). The findings suggest that a weight loss intervention using meal replacements in the preconception period was acceptable and may result in greater weight loss than conventional dietary advice alone.

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An effectiveness trial showed lipid-based nutrient supplementation but not corn–soya blend offered a modest benefit in weight gain among 6- to 18-month-old underweight children in rural Malawi

Public Health Nutrition ◽

10.1017/s1368980012003023 ◽

2012 ◽

Vol 15 (9) ◽

pp. 1755-1762 ◽

Cited By ~ 23

Author(s):

Chrissie M Thakwalakwa ◽

Per Ashorn ◽

Mpumulo Jawati ◽

John C Phuka ◽

Yin Bun Cheung ◽

...

Keyword(s):

Weight Gain ◽

National Health Service ◽

Health Service ◽

National Health ◽

Infants And Children ◽

Serious Adverse Events ◽

Intention To Treat ◽

Randomised Controlled ◽

And Control ◽

To Receive

AbstractObjectiveTo determine if supplementation with corn–soya blend (CSB) or lipid-based nutrient supplement (LNS) improved the weight gain of moderately underweight infants and children when provided through the national health service.DesignA randomised, controlled, assessor-blinded clinical trial. Infants and children were randomised to receive for 12 weeks an average daily ration of 71 g CSB or 43 g LNS, providing 1188 kJ and 920 kJ, respectively, or no supplement (control). Main outcome was weight gain. Secondary outcomes included changes in anthropometric indices and incidence of serious adverse events. Intention-to-treat analyses were used.SettingKukalanga, Koche, Katema and Jalasi health centres in Mangochi District, rural Malawi.SubjectsUnderweight (weight-for-age Z-score <−2) infants and children aged 6–15 months (n 299).ResultsMean weight gain was 630 g, 680 g and 750 g in control, CSB and LNS groups, respectively (P = 0·21). When adjusted for baseline age, children receiving LNS gained on average 90 g more weight (P = 0·185) and their weight-for-length Z-score increased 0·22 more (P = 0·049) compared with those receiving no supplementation. No statistically significant differences were observed between the CSB and control groups in mean weight and length gain.ConclusionsLNS supplementation provided during the lean season via through the national health service was associated with a modest increase in weight. However, the effect size was lower than that previously reported under more controlled research settings.

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Restorative Outcomes of a Minimally Invasive Restorative Approach Based on Atraumatic Restorative Treatment to Manage Early Childhood Caries: A Randomised Controlled Trial

Caries Research ◽

10.1159/000442093 ◽

2015 ◽

Vol 50 (1) ◽

pp. 1-8 ◽

Cited By ~ 10

Author(s):

Peter Arrow

Keyword(s):

Care Setting ◽

Controlled Trial ◽

Control Group ◽

Atraumatic Restorative Treatment ◽

Restorative Treatment ◽

Intention To Treat ◽

Restoration Failure ◽

Randomised Controlled ◽

And Control

A pragmatic randomised controlled trial comparing a minimally invasive approach based on atraumatic restorative treatment (ART) procedures (test) was tested against the standard-care approach (control) to treat early childhood caries (ECC) in a primary-care setting in Perth, W.A., Australia. Parent/child dyads with ECC were allocated to the test or control group using stratified block randomisation. Children were examined at baseline and follow-up by two calibrated examiners blinded to group allocation status. Dental therapists trained in ART provided treatment to the test group and dentists treated the control group. Restoration quality was evaluated at follow-up using the ART criteria. Data were analysed on an intention-to-treat basis; test of proportions, Wilcoxon rank test and logistic regression, controlling for clustering of teeth, were used. Two hundred and fifty-four children were randomised (test = 127 and control = 127). There was no statistically significant difference in age, sex and baseline caries experience between the test and control groups. At follow-up (mean interval 11.4 months, SD 3.1), 220 children were examined (test = 115 and control = 105) and 597 teeth (test = 417 and control = 180) were evaluated for restoration quality, of which 16.8% (test) and 6.7% (control) were judged to have failed (required replacement; p < 0.01). Intention-to-treat, multiple logistic regression found multisurface restorations (OR = 10.4) had significantly higher odds of failure, while referral for specialist paediatric care had significantly lower odds of restoration failure (OR = 0.2). The ART-based approach enabled more children and teeth to be treated, and multisurface restoration and treatment in a primary-care setting had higher odds of restoration failure.

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Prevention and control of sexually transmissible infections among hotel-based female sex workers in Dhaka, Bangladesh

Sexual Health ◽

10.1071/sh12165 ◽

2013 ◽

Vol 10 (6) ◽

pp. 478 ◽

Cited By ~ 3

Author(s):

Duncan F. McCormick ◽

Motiur Rahman ◽

Sabrina Zadrozny ◽

Anadil Alam ◽

Lutfa Ashraf ◽

...

Keyword(s):

Condom Use ◽

Sex Workers ◽

Low Cost ◽

Controlled Trial ◽

Presumptive Treatment ◽

Sexually Transmissible Infections ◽

Implementation Studies ◽

Randomised Controlled ◽

And Control ◽

To Receive

BackgroundHotel-based sex workers in Bangladesh have high rates of sexually transmissible infections (STIs), high client turnover and low condom use. Two monthly clinic-based strategies were compared: periodic presumptive treatment (PPT) and enhanced syndromic management (ESM) – one round of presumptive treatment followed by treatment based on assessment and laboratory tests. Methods: A randomised controlled trial compared PPT and ESM by prevalence and incidence, behaviour, retention, cost and STI incidence and prevalence. Demographic, behavioural and clinical data were collected from women at two clinics in Dhaka. All women received presumptive treatment and were randomised to receive PPT or ESM at nine monthly visits. Results: In total, 549 women (median age: <20 years) were enrolled. At baseline, the prevalence of chlamydia (Chlamydia trachomatis) and gonorrhoea (Neisseria gonorrhoeae) was 41% (ESM: 41%; PPT: 42%). After 9 months, chlamydia and gonorrhoea decreased to 7% overall, (ESM: 7.4%; PPT: 6.8%). At each visit, 98% of women receiving ESM met the therapy criteria and were treated. Retention was low (50%). Total costs were 50% lower per visit for each woman for PPT (ESM: $11.62 v. PPT: $5.80). The number of sex work sessions was reduced from 3.3 to 2.5 (P < 0.001), but income did not change. Coercion was reduced but condom use at last sex did not change significantly. Conclusions: Monthly PPT and ESM were effective approaches for STI control. PPT offered a feasible, low-cost alternative to ESM. Educational aspects led to a reduction in coercion and fewer sessions. Implementation studies are needed to improve condom use and retention.

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V10 The role of surgical trainees in recruiting to multicentre RCTs: an example from the Sunflower Study

BJS Open ◽

10.1093/bjsopen/zrab034.009 ◽

2021 ◽

Vol 5 (Supplement_1) ◽

Author(s):

Lucy Huppler ◽

Sarah Staight ◽

Tomas Urbonas ◽

Judith Johnston ◽

Yegor Tryliskyy ◽

...

Keyword(s):

Controlled Trial ◽

Expectant Management ◽

Common Bile Duct Stones ◽

Surgical Trainees ◽

Number Of Patients ◽

Research Nurses ◽

Randomised Controlled ◽

The Uk ◽

To Receive

Abstract Background The Sunflower Study aims to compare the effectiveness of expectant management and MRCP prior to laparoscopic cholecystectomy (LC) in patients at low or moderate risk of common bile duct stones. This is the largest surgical randomised controlled trial (RCT) in the UK and a secondary aim is to describe trainees’ contributions. Methods Participants are randomised to receive expectant management or MRCP in a 2:1 ratio. Over 13,500 patients from more than 50 UK hospitals are required over five years. Trainees’ contributions are documented as follows: total number signed up to the study; number enrolled in the NIHR associate PI scheme; and the number of patients approached and recruited. The proportion of ‘emergency’ and ‘elective’ patients recruited was also recorded. Results Sunflower has been open since February 2019 and 48 centres are currently participating. A total of 104 trainees have been actively involved and 34 are/have been enrolled in the associate PI scheme. To date, 3992 patients have been screened, by trainees (n = 719,18%), consultants (n = 439,11%) and research nurses (n = 2214,71%). 1996 patients have been recruited, 359(18%) of which by trainees, 319(16%) consultants and 1318(66%) research nurses. Of the recruited patients, 423 (21%) presented as emergencies, recruited by trainees (n = 169,40%), consultants (n = 59,14%) and research nurses (n = 195,46%). Conclusions Trainees have an important role to play in recruiting patients to multicentre surgical RCTs, in particular in emergency settings, which can help improve studies’ generalisability. The associate PI scheme seems to provide an extra incentive for trainees to be involved in an RCT.

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Mechanical bowel preparation and oral antibiotics versus mechanical bowel preparation only prior rectal surgery (MOBILE2): a multicentre, double-blinded, randomised controlled trial—study protocol

BMJ Open ◽

10.1136/bmjopen-2021-051269 ◽

2021 ◽

Vol 11 (7) ◽

pp. e051269

Author(s):

Laura Koskenvuo ◽

Pipsa Lunkka ◽

Pirita Varpe ◽

Marja Hyöty ◽

Reetta Satokari ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Bowel Preparation ◽

Controlled Trial ◽

Rectal Surgery ◽

Mechanical Bowel Preparation ◽

Oral Antibiotic ◽

Oral Antibiotics ◽

Number Of Patients ◽

Randomised Controlled ◽

Double Blinded

IntroductionMechanical bowel preparation (MBP) prior to rectal surgery is widely used. Based on retrospective data many guidelines recommend mechanical and oral antibiotic bowel preparation (MOABP) to reduce postoperative complications and specifically surgical site infections (SSIs). The primary aim of this study is to examine whether MOABP reduces complications of rectal surgery.Methods and analysisThe MOBILE2 (Mechanical Bowel Preparation and Oral Antibiotics vs Mechanical Bowel Preparation Only Prior Rectal Surgery) trial is a multicentre, double-blinded, parallel group, superiority, randomised controlled trial comparing MOABP to MBP among patients scheduled for rectal surgery with colorectal or coloanal anastomosis. The patients randomised to the MOABP group receive 1 g neomycin and 1 g metronidazole two times on a day prior to surgery and patients randomised to the MBP group receive identical placebo. Based on power calculations, 604 patients will be enrolled in the study. The primary outcome is Comprehensive Complication Index within 30 days after surgery. Secondary outcomes are SSIs within 30 days after surgery, the number and classification of anastomosis dehiscences, the length of hospital stay, mortality within 90 days after surgery and the number of patients who received adjuvant treatment if needed. Tertiary outcomes are overall survival, disease-specific survival, recurrence-free survival and difference in quality-of-life before and 1 year after surgery. In addition, the microbiota differences in colon mucosa are analysed.Ethics and disseminationThe Ethics Committee of Helsinki University Hospital approved the study. The findings will be disseminated in peer-reviewed academic journals.Trial registration numberNCT04281667.

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Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting

BMJ Open ◽

10.1136/bmjopen-2020-048178 ◽

2021 ◽

Vol 11 (6) ◽

pp. e048178

Author(s):

Katie Mellor ◽

Saskia Eddy ◽

Nicholas Peckham ◽

Christine M Bond ◽

Michael J Campbell ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

A Priori ◽

Pilot Trial ◽

Public Library ◽

Feasibility Studies ◽

Methodological Review ◽

Pilot Trials ◽

Trial Protocols ◽

Randomised Controlled

ObjectivesPrespecified progression criteria can inform the decision to progress from an external randomised pilot trial to a definitive randomised controlled trial. We assessed the characteristics of progression criteria reported in external randomised pilot trial protocols and results publications, including whether progression criteria were specified a priori and mentioned in prepublication peer reviewer reports.Study designMethodological review.MethodsWe searched four journals through PubMed: British Medical Journal Open, Pilot and Feasibility Studies, Trials and Public Library of Science One. Eligible publications reported external randomised pilot trial protocols or results, were published between January 2018 and December 2019 and reported progression criteria. We double data extracted 25% of the included publications. Here we report the progression criteria characteristics.ResultsWe included 160 publications (123 protocols and 37 completed trials). Recruitment and retention were the most frequent indicators contributing to progression criteria. Progression criteria were mostly reported as distinct thresholds (eg, achieving a specific target; 133/160, 83%). Less than a third of the planned and completed pilot trials that included qualitative research reported how these findings would contribute towards progression criteria (34/108, 31%). The publications seldom stated who established the progression criteria (12/160, 7.5%) or provided rationale or justification for progression criteria (44/160, 28%). Most completed pilot trials reported the intention to proceed to a definitive trial (30/37, 81%), but less than half strictly met all of their progression criteria (17/37, 46%). Prepublication peer reviewer reports were available for 153/160 publications (96%). Peer reviewer reports for 86/153 (56%) publications mentioned progression criteria, with peer reviewers of 35 publications commenting that progression criteria appeared not to be specified.ConclusionsMany external randomised pilot trial publications did not adequately report or propose prespecified progression criteria to inform whether to proceed to a future definitive randomised controlled trial.

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