Scalp Cooling Alopecia Prevention trial (SCALP) for patients with early stage breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10088-10088 ◽  
Author(s):  
Julie R. Nangia ◽  
Tao Wang ◽  
Cynthia R. C. Osborne ◽  
Polly Ann Niravath ◽  
Kristen Otte ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Randomized Trial ◽  
Interim Analysis ◽  
Randomized Trials ◽  
Early Stage ◽  
Control Group ◽  
P Value ◽  
Scalp Cooling ◽  
Success Rates

10088 Background: Adjuvant chemotherapy decreases the risk of recurrence. However, it has distressing side effects, including alopecia. There are no randomized trials assessing modern scalp cooling to prevent alopecia, and success rates in non-randomized trials have varied. Methods: We conducted a multi-center randomized trial to evaluate the safety and efficacy of the Orbis Paxman Hair Loss Prevention System (OPHLPS) in reducing chemotherapy-induced alopecia. Women with stage I-II breast cancer planned to receive anthracycline- or taxane- based chemotherapy for at least four cycles were eligible and randomized in a 2:1 ratio to scalp-cooling or control. Scalp-cooling was done with the OPHLPS 30 minutes prior to, during and 90 minutes after each chemotherapy. The primary efficacy endpoints were hair preservation and device safety. We planned to enroll 235 subjects to provide 85% power to detect a 20% difference in hair preservation. Secondary endpoints included wig/scarf use and quality of life assessed by the EORTC QLQ-30, HADS and BIS. Subjects will be followed for 5 years for recurrence, overall survival, and site of recurrence. One interim analysis was planned to allow the study to stop early for efficacy after 142 subjects were enrolled and evaluable for the primary endpoint. To maintain the overall type 1 error rate, an O’Brien-Fleming spending function was used (interim boundary p = 0.0061). Results: This is the first randomized trial with modern scalp cooling in the world. For the interim analysis, 142 subjects were evaluable. Among them, 48 (50.5%) out of 95 in the cooling group and 0 (0%) out of 47 in the control group had hair preservation. The one-tailed p-value from the Fisher’s exact test is < 0.0001, which crosses the superiority boundary (p = 0.0061). Thus on 9/26/2016 the DSMB stopped the study early. The interim analysis was presented at SABCS 2016. There are 195 subjects enrolled on this clinical trial, and the final subject will be evaluable for the primary outcome February 2017. The final analysis will be presented. Conclusions: Our trial showed that scalp cooling using OPHLPS is highly effective in hair retention. Paxman Coolers has applied for FDA clearance for the OPHLPS based on the results of the interim analysis. Clinical trial information: NCT01986140.

scholarly journals Effect of Baduanjin exercise intervention on cognitive function and quality of life in women with breast cancer receiving chemotherapy: study protocol of a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xiao-Lin Wei ◽  
Ru-Zhen Yuan ◽  
Yong-Mei Jin ◽  
Shu Li ◽  
Ming-Yue Wang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Cognitive Function ◽  
Exercise Intervention ◽  
Early Stage ◽  
Early Stage Breast Cancer ◽  
Pharmacological Intervention ◽  
Control Group

Abstract Background More than 50% cognitive impairment was reported by cancer patients before and after medical treatment. However, there are no effective interventions to manage the cognitive problem in women with breast cancer. This pilot study was designed to evaluate the protective effect of Baduanjin exercise on cognitive function and cancer-related symptoms in women with early-stage breast cancer undergoing chemotherapy. Method A single-blinded, randomized control trial was designed. The trial will recruit 70 patients with early-stage breast cancer scheduled to receive chemotherapy from Shanghai in China. All participants will be randomly assigned to (1:1) the supervised Baduanjin group (5 times/week, 30 min each time) or the wait-list control group for 3 months. The effect of Baduanjin exercise intervention will be evaluated by outcome measures including subjective and objective cognitive function, symptoms (fatigue, depression, and anxiety), and health-related quality of life at pre-intervention (T0), 8 weeks (T1), and 12 weeks (T2). The PCI score in the FACT-Cog as the primary cognitive outcome will be reported descriptively, while effect sizes and 95% confidence intervals (CIs) will be calculated. The collected data will be analyzed by using an intention-to-treat principle and linear mixed-effects modeling. Discussion This is the first randomized clinical trial to investigate whether Baduanjin exercise will have a positive role in improving cognitive function in women with breast cancer receiving chemotherapy. If possible, Baduanjin exercise will be a potential non-pharmacological intervention to manage cognitive dysfunction and promote survivorship care among breast cancer survivors. Trial registration Chinese Clinical Trial Registry (ChiCTR) ChiCTR2000033152. Registered on 22 May 2020

Final analysis of nelipepimut-S plus GM-CSF with trastuzumab versus trastuzumab alone to prevent recurrences in high-risk, HER2 low-expressing breast cancer: A prospective, randomized, blinded, multicenter phase IIb trial.

2019 ◽  
Vol 37 (8_suppl) ◽  
pp. 1-1 ◽  
Author(s):  
Annelies Hickerson ◽  
G. Travis Clifton ◽  
Diane F. Hale ◽  
Kaitlin M. Peace ◽  
Jarrod P. Holmes ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Interim Analysis ◽  
Prolonged Exposure ◽  
Early Stage ◽  
Final Analysis ◽  
Control Group ◽  
Gm Csf ◽  
Disease Free ◽  
Clinical Trial Information

1 Background: Preclinical data shows synergism between trastuzumab (Tz) and HER2-targeted vaccines. We evaluated adjvuant nelipepimut-S (NPS) + GM-CSF with Tz compared to Tz with GM-CSF alone in HER2 low-expressing (LE) breast cancer (BC) patients (pts) to prevent recurrences. After a planned interim analysis showed benefit in triple negative BC (TNBC) pts, the decision was made to close the trial with guidance from the independent DSMB. Here, we report the final analysis of the trial with 7 months (mo) of added follow-up (f/u). Methods: The phase 2b trial enrolled clinically disease-free BC pts after standard therapy. Pts were HLA-A2, A3, A24, and/or A26+, had HER2-LE (IHC 1-2+, FISH non-amplified) BC and were node positive and/or TNBC. Pts were randomized to placebo with GM-CSF(control group, CG) or NPS with GM-CSF (vaccine group, VG), while all received Tz Q3wk for 1 year. GM-CSF or NPS + GM-CSF were given q3wks x 6 starting with the 3rd Tz dose, and boosters every 6 months x 4. Safety was assessed and pts were followed clinically for recurrences. The primary outcome was DFS at 24 mo. Results: 589 pts were screened at 26 sites. 275 pts were enrolled and randomized (VG:136, CG:139). There were no clinicopathologic differences between groups. Concurrent Tz and NPS was safe with no added overall or cardiac toxicity compared to CG and no grade 4/5 toxicities. In the ITT analysis (median f/u 25.7 mo), the estimated DFS was favorable but did not reach significance in the VG compared with the CG (HR 0.62, 95% CI: 0.31-1.25, p = 0.18). In the TNBC pts, the VG had statistically improved DFS compared to the CG (HR 0.26, 95% CI: 0.08-0.81, p = 0.013). Conclusions: The combination of NPS with Tz is safe with no added toxicity compared to Tz alone, even after prolonged exposure (25.7 mo). In this final analysis, there was a trend towards benefit in the ITT population that improved since the interim analysis with added f/u. The significant benefit seen at interim in the TNBC pts continued to strengthen in the VG group. These findings could position the NPS + Tz combination as an adjuvant therapy for early-stage TNBC and warrant further study. Clinical trial information: NCT01570036.

scholarly journals The Effect of Health Literacy Counselling on Self-Care in Women after Mastectomy: a Randomized Clinical Trial

2020 ◽  
Vol 9 (1) ◽  
pp. 39-45
Author(s):  
Masoume Rastegar ◽  
Zohreh Mahmoodi ◽  
Sara Esmaelzadeh Saeieh ◽  
Nasibeh Sharifi ◽  
Kourosh Kabir
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Health Literacy ◽  
Intervention Group ◽  
Self Care ◽  
Essential Element ◽  
World Health ◽  
Control Group ◽  
Fars Province ◽  
The Mean

Introduction: Breast cancer has a high prevalence, constituting a major cause of mortality in women around the world. Health literacy has a vital role in the self-care of chronic diseases such as cancer and is an essential element in the ability of each person to engage with health promotion. The aim of this study was to determine effect of health literacy counselling on selfcare in women after mastectomy. Methods: This study is a randomized, controlled, clinical trial carried out on 72 women with breast cancer after mastectomy in Fars province. The eligible women entered the study using convenience sampling and were then divided into an intervention and a control group through randomized blocks of four. Health literacy questionnaire and self-care questionnaire were distributed among the participants before, immediately after and three weeks following the intervention. Data analysis was performed in SPSS ver.13. Results: The results showed no significant differences between the two groups in terms of their health literacy and self-care scores before the intervention (P=0.299 and 0.059). A comparison of the mean values showed a greater increase in the mean score of health literacy and score of selfcare immediately and three weeks after the intervention in the intervention group compared to the control group. Also, the mean score of the dimensions of self-care in chemotherapy increased over time in the intervention group. Conclusion: The findings of this study confirm the higher effectiveness of counseling with a health literacy approach on overall self-care in chemotherapy and all its dimensions.

scholarly journals Investigating a Newly Developed Educational Orthopedic Application for Medical Interns in a Before-after Quasi-clinical Trial Study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mahla Daliri B.O. ◽  
Hassan M. Majd ◽  
Ali Moradi
Keyword(s):  
Clinical Trial ◽  
Medical Knowledge ◽  
Correlational Analysis ◽  
Control Group ◽  
P Value ◽  
Case Group ◽  
Final Exam ◽  
Vas Scores ◽  
Medical Interns ◽  
Exam Scores

Abstract Background In COVID 19 era, the literature on e-learning, or particularly m-learning, has considerably increased focusing on the subject of medical knowledge transfer. Considering the importance of orthopedic knowledge for general practitioners and the inadequacy of the orthopedics internship duration in Mashhad University of Medical Sciences (MUMS), we have developed and investigated a smartphone orthopedic educational application named “Orthobox”. Methods In a quasi-clinical before-after trial study, we investigated the benefits of Orthobox application for medical interns attending MUMS orthopedic departments. A total of 120 students (64 and 56 students in control and case groups respectively) were recruited. The application consists of five main parts of medication, common order samples, common prescriptions, cast and splint types, and educational movies. Students who passed the course without getting access to the application (control group) and students who were also using application during the course (case group) were defined, and comparison was done between them objectively through final exam score comparison and subjectively through Visual Analogue Scale (VAS) questionnaire score comparison. Besides, using case group students’ activity report provided by the application panel, correlational analysis was done on their amount of activity on each of the main parts of the application and the corresponding question exam and VAS score separately. Results The case group of the study generally achieved higher final exam scores, mainly on Order question score (P value<0.001). Total VAS scores were also greater in case group (P value =0.001). It has also been identified that there is a notable positive trend between student’s amount of usage of the application and their final exam scores through correlational analysis. This correlation was not significant about students’ application visit numbers and VAS scores. Conclusion These results suggest that m-learning has got the potential to improve students’ medical knowledge and skills by organizing must-to-learn content specified for intern students of orthopedics on one hand, and cause more satisfaction in students about their education on the other hand. Trial registration This study was not registered because it is a quasi-clinical trial study. Level of evidence Level III (Evidence obtained from well-designed controlled trials without randomization (i.e. quasi-experimental).

scholarly journals Study of the correlation between CA15-3 and each of prolactin hormone and lactate dehydrogenase enzyme in women with breast cancer in THI – QAR governorate – Iraq

2019 ◽  
Vol 10 (3) ◽  
pp. 1751-1755
Author(s):  
Hadeel Rashid Faraj
Keyword(s):  
Breast Cancer ◽  
Lactate Dehydrogenase ◽  
Cancer Patients ◽  
Early Stage ◽  
Control Group ◽  
Breast Cancer Patients ◽  
Correlation Relationship ◽  
Dehydrogenase Enzyme ◽  
Coefficient Corrélation ◽  
Prolactin Hormone

The most malicious tumor in women is breast cancer. Its treatment at the early stage of its recognition in a woman provides her multiple options for diagnosis. Physical inspection and mammography are helpful screening processes for the primary recognition of breast cancer, they are also labor dependent and need health specialists who are exceptionally prepared and skilled. This experiment was designed to estimate and compare the CA15-3 level, hormone, and Lactate dehydrogenase enzyme in Breast Cancer patients and in apparently healthier individuals. Blood CA15-3, hormone, and Lactate dehydrogenase enzyme levels were determined in 65 Women with Breast Cancer and 55 apparently healthy subjects. The levels of serum CA15-3, hormone, and Lactate dehydrogenase enzyme were showing a significant increase in women with Breast Cancer in comparison to the control group (P ≤ 0.05). The study also investigates the correlation between the concentrations of the CA15-3 and each of hormone, and Lactate dehydrogenase enzyme, However, we compared all measurement parameters according to the type of disease. In Breast cancer patients, we increase CA15-3, hormone, and Lactate dehydrogenase enzyme can clearly occur, and we positive correlation relationship between CA15-3 and each of PRL and LDH through coefficient correlation (r).

scholarly journals Effect of Probiotics on Allergic Rhinitis: A Randomized, Controlled, Clinical Trial

2020 ◽  
Vol 9 ◽  
pp. 1918 ◽  
Author(s):  
Mahnaz Sadeghi-Shabestari ◽  
Yalda Jabbari Moghaddam ◽  
Hasan Rezapoor ◽  
Mojataba Sohrabpour
Keyword(s):  
Clinical Trial ◽  
Allergic Rhinitis ◽  
Standard Therapy ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Nasal Discharge ◽  
Oral Corticosteroids ◽  
And Control

Background: Allergic rhinitis (AR) is one of the most common diseases in the world and affects about 10-50% of the general population. Probiotics are live microorganisms that help the normal state of the intestine, and if prescribed correctly, they can stimulate the mucosal immune system to prevent inflammatory symptoms of allergy and atopy. The present study aims to investigate the role of probiotics in the treatment of AR when added to standard therapy as adjuvant agents. Materials and Methods: In this clinical trial study, 28 patients older than 15 years with AR randomly divided into probiotics and control groups. The probiotics group received standard therapy for AR accompanied by probiotic capsules every 12 hours for eight weeks, whereas the control group received standard therapy for AR with placebo capsules as the same protocol. Data were analyzed using SPSS Version 23 (IBM Corporation, Armonk, NY, USA) and, the P-value less than 0.05 was considered statistically significant. Results: In the probiotics group, 14.3% of patients had sneezing at the baseline, which significantly decreased to 4.6% (P<0.01). Also, the necessity for nasal and oral corticosteroids after treatment with probiotics in the probiotics group was less than the control group (P<0.01). Although cough, nasal discharge, conchae hypertrophy, and night sleep disorders reduced after treatment with probiotics, this reduction was not statistically significant between the two groups. Conclusion: Based on the results of this clinical trial, the use of probiotics had no significant effect on the outcome of patients with AR. [GMJ.2020;9:e1918] 

scholarly journals Pengaruh Pendidikan Kesehatan Tentang Inspeksi Asam Asetat (IVA) Terhadap Motivasi Wus dalam Deteksi Kanker Serviks di Puskesmas Putri Ayu Jambi

2019 ◽  
Vol 19 (1) ◽  
pp. 42
Author(s):  
Hesty Hesty ◽  
Rahmah Rahmah ◽  
Nurfitriani Nurfitriani
Keyword(s):  
Cervical Cancer ◽  
Health Education ◽  
Early Stage ◽  
Sampling Technique ◽  
World Health ◽  
Control Group ◽  
P Value ◽  
Childbearing Age ◽  
Control Group Design ◽  
Experimental Group

World Health Organization (WHO), cervical cancer is the number two cause of death in the world for women from all existing cancer. Every two minutes a woman dies of this disease. This cancer attack at an early stage does not cause any symptoms. That is why, why does this type of cancer fall into the category of the silent killer. One of the promotive and preventive efforts in women of childbearing age as primary prevention can be through the provision of health education about cervical cancer using the Acetic Acid Inspection (IVA) method. The purpose of this study is to find out whether there is an influence of health education about IVA on WUS motivation in cervical cancer detection in health centers. Putri Ayu Jambi. This type of quantitative research with non randomized pretest-posttest with control group design, with purposive sampling technique totaling 22 WUS, 11 people as controls and 11 experimental people. The instrument in the form of questionnaires was analyzed by univariate and bivariate Paired Test t-test, which was conducted from April to July 2018.  The results of the study revealed that of the 22 WUSs studied, the average motivation of the pretest in the experimental group was 41.1818 and the control group was 39.9091, while the results of the posttest of the experimental group after being given counseling and leaflets increased by 42.9091 with p-value 0.034. There is an influence of health education about IVA tests on WUS motivation in detecting cervical cancer. It is suggested that the Puskesmas can improve activities in planning disease control programs, especially carrying out counseling and counseling both in the puskesmas building and in the working area of the puskesmas by involving cadres in their environment so that WUS is moved to take the IVA examination.

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