Effects of Orthoptic Therapy in Children with Intermittent Exotropia After Surgery: Study Protocol for a Randomized Controlled Trial

Abstract Background Intermittent exotropia (IXT) is the most common type of exotropia in China. Surgery is usually required to align the eye deviation to maintain or obtain better binocular visual function. However, there is a high rate of exodrift or recurrence in surgically treated patients. Orthoptic therapy is sometimes recommended for IXT patients after surgery. However, there is a lack of high-quality randomized controlled trials to prove that orthoptic therapy could be an effective supplement to surgical treatment for IXT patients. This study was designed to confirm such an application. This report describes the design and methodology of the Intermittent Exotropia Post-operative Treatment Clinical Trial, which is the first large-sample, blank-controlled, randomized clinical trial. Methods A total of 136 IXT patients (aged 7 to 17 years) will be enrolled and assigned to the orthoptic therapy group or blank control group according to a simple randomization scheme. Patients in the orthoptic therapy group will receive at least 2 months of orthoptic therapy, such as anti-suppression, vergence, and accommodation training. Patients in the blank control group will receive only refractive correction. All enrolled patients will need regular follow-up observation until 2 years after surgery. The primary outcome will be the proportion of participants meeting suboptimal surgical outcomes in this 2-year follow-up, which is defined as (1) exodeviation of 10 prism diopters (PD) at distance or near using the simultaneous prism and cover test (SPCT) or (2) loss of 2 or more octaves of stereoacuity from baseline, at any masked follow-up visit examination. The secondary outcomes will be the exodeviation at distance and near using the simultaneous prism and alternate cover test (PACT), magnitude of fusional convergence, stereoacuity, and accommodation. Measurements will be taken at baseline and at the 6-, 12-, 18-, and 24-month follow-ups. Discussion To the best of our knowledge, this will be the first prospective, randomized controlled study of binocular training in IXT patients after surgery. The aim of this work is to confirm the efficacy of orthoptic therapy in reducing the proportion of recurrence among IXT patients after surgery and improving binocular vision function. Trial registration: Chinese Clinical Trial Registry ChiCTR1900026891. Registered on 25 October 2019.

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Effectiveness of Abdominal and Gluteus Medius Training in Lumbo-Pelvic Stability and Adductor Strength in Female Soccer Players. A Randomized Controlled Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18041528 ◽

2021 ◽

Vol 18 (4) ◽

pp. 1528

Author(s):

Héctor Guerrero-Tapia ◽

Rodrigo Martín-Baeza ◽

Rubén Cuesta-Barriuso

Keyword(s):

Repeated Measures ◽

Gluteus Medius ◽

Soccer Players ◽

Controlled Study ◽

Control Group ◽

Extrinsic Factors ◽

Randomized Controlled ◽

Limb Injuries ◽

Experimental Group

Background. Abdominal and lumbo-pelvic stability alterations may be the origin of lower limb injuries, such as adductor pathology in soccer players. Imbalance can be caused by both intrinsic and extrinsic factors. Methods: In this randomized controlled trial over 8 weeks, 25 female footballers were randomly allocated to an experimental group (isometric abdominal training and gluteus medius-specific training) or a control group (isometric abdominal training). Evaluations were performed at baseline, at the end of the intervention and after a 4-week follow-up period. The exercise protocol in common for both groups included three exercises: Plank, Lateral plank and Bird dog. Specific exercises for the gluteus medius were: Pelvic drop and Stabilization of the gluteus medius in knee valgus. Outcome measures were lumbar-pelvic stability and adductor strength. Results: After the intervention, there was an increase in lumbo-pelvic stability in both groups, being greater in the control group than in the experimental group (mean differences [MD]: 4.84 vs. MD: 9.58; p < 0.01) with differences in the analysis of repeated measures (p < 0.001), but not in group interaction (p = 0.26). Changes were found in adductor strength in the experimental group (MD: −2.48; p < 0.001 in the left adductor; MD: −1.48; p < 0.01 in right adductor) and control group (MD: −1.68; p < 0.001 in the left adductor; MD: −2.05; p < 0.001 in the right adductor) after the intervention, with differences in the analysis of repeated measures in left (p < 0.001) and right (p < 0.001) adductor strength. Conclusions: An abdominal and gluteal training protocol shows no advantage over a protocol of abdominal training alone for lumbo-pelvic stability and adductor strength, while improvements in both variables are maintained at four weeks follow-up.

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Effect of Xiangbin Prescription in Gastrointestinal Function After Gynecological Abdominal Surgery: a Randomized Controlled Trial

10.21203/rs.3.rs-660427/v1 ◽

2021 ◽

Author(s):

Yuyan Wu ◽

Jinxuan Lin ◽

Haiping Zeng ◽

Yi Chen ◽

Zhiqiang Chen ◽

...

Keyword(s):

Postoperative Complications ◽

Abdominal Surgery ◽

Controlled Trial ◽

Controlled Study ◽

Chewing Gum ◽

Control Group ◽

Gastrointestinal Function ◽

Blank Control Group ◽

Randomized Controlled ◽

Significant Difference

Abstract Background: Recovery of gastrointestinal function after gynecological abdominal surgery is a major clinical problem. An effective intervention to promote the rapid recovery of gastrointestinal function postoperatively is lacking. This randomized trial investigated whether Xiangbin prescription (XBP) was feasible in terms of efficacy and safety on gastrointestinal function recovery in patients after gynecological abdominal surgery. Methods: A randomized controlled study was conducted, in which 190 patients with gynecological abdominal surgery who met the inclusion and exclusion criteria were enrolled. They were assigned randomly to XBP group, chewing gum group or blank control group, and respectively received the following treatments: took the XBP twice a day, chewed a piece of gum for about 15 minutes each 4 hours, or received conventional western basic treatment, starting on postoperative day 1 until defecation. Three groups were compared in terms of primary outcomes including the time of the first defecation and the time of the first flatus and secondary outcomes including the level of Ghrelin (GHRL) and the incidence of postoperative complications. Meanwhile, the safety of this trial was evaluated. Results: There was no statistical difference in baseline characteristics among the three groups. For the time of the first flatus, XBP group (22.33 ± 6.68 h) showed less time compared with the chewing gum group (23.06 ± 7.37 h), while it was shorter than that in the blank control group (25.86 ± 7.93 h) with significant difference (P < 0.05). As for the time of the first defecation, XBP group (38.65 ± 12.96 h) showed shorter time significantly compared with both the chewing gum group (47.29 ± 14.50 h) and the blank control group (54.01 ± 20.32 h) (P < 0.05). For the postoperative GHRL levels, XBP group was higher than that in the chewing gum group with no significant difference and had more significant improvement of the GHRL levels at postoperative day 3 compared with the blank control group (P < 0.05). For postoperative complications, XBP group had lower incidence than the other two groups but with no significant difference. For safety evaluations, no serious adverse events occurred in the three groups. Conclusions: XBP could promote the recovery of gastrointestinal function after gynecological abdominal surgery and it is overall safe. Trial registration: This trial was retrospectively registered by Chinese Clinical Trial Registry with the identifier number, ChiCTR1900026327, at September 30, 2019. http://www.chictr.org.cn/.

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Stuck-moving Needle acupuncture the Myofascial Triggers Point to treat Idiopathic Frozen Shoulders: study protocol for a randomized controlled trial

10.21203/rs.3.rs-20100/v1 ◽

2020 ◽

Author(s):

YANG BAI ◽

Ying Wang ◽

Bo Chen ◽

Qianqian Lei ◽

Hailong Zhao ◽

...

Keyword(s):

Clinical Trial ◽

Controlled Trial ◽

Frozen Shoulder ◽

Baseline Period ◽

Control Group ◽

Trial Registry ◽

Clinical Trial Registry ◽

Randomized Controlled ◽

Needle Acupuncture

Abstract Background There are evidences for the efficacy of acupuncture treatment for chronic shoulder pain, however it remains unclear the best acupuncture modes for effective treatment. We compared the effect of myofascial trigger point (MTrp) Stuck-moving Needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The ultimate aim of the study is to select an effective therapy for patients with idiopathic frozen shoulder. Methods Randomized controlled trial will be conducted in the 3 clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital and Qingyang Second People's Hospital in China from February 2020 to January 2021. One-hundred and eight frozen shoulder patient will be recruited and randomized into one of three groups in a 1:1:1 ratio of the Stuck-moving Needle acupuncture group, Common acupuncture control group and physical exercise control group. This trial will include a 1-week baseline period, a 3-weeks of treatment period, and a 12-weeks of follow-up period. During the 3-weeks of treatment period, patients will receive 9 sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and Measurement of range of joint motion (ROM) from baseline period to the 12-week follow-up period. Secondary outcome measures will include, measurement of Pressure Pain Threshold (PPT), Pressure Pain Tolerance (PTT) Oxford Shoulder Score (OSS), 36-item Short Form survey and Patient satisfaction evaluation. Adverse events also will be recorded for safety assessment. Discussion The results of this trial will allow us to compare the difference in efficacy between Stuck-moving Needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals. Trial registration: Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). registered on 22, Dec. 2019

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Effect of the Use of WeChat to Disseminate Preoperative Health Education to Parents of Children with Restrictive Ventricular Septal Defects: A Prospective Randomized Controlled Study

The Heart Surgery Forum ◽

10.1532/hsf.3323 ◽

2020 ◽

Vol 23 (6) ◽

pp. E897-E901

Author(s):

Qiliang Zhang ◽

Ning Xu ◽

Shuting Huang ◽

Qiang Chen ◽

Hua Cao

Keyword(s):

Health Education ◽

Ventricular Septal Defect ◽

Septal Defect ◽

Preoperative Care ◽

Randomized Controlled Study ◽

Controlled Study ◽

Control Group ◽

Loss To Follow Up ◽

Randomized Controlled

Background: This study explored the clinical effect of implementing WeChat-based preoperative health education for parents of children with restrictive ventricular septal defect. Methods: A prospective randomized controlled study was conducted in a provincial hospital on the southeast coast of China. Participants were randomly divided into an intervention (WeChat) group (n = 35) and a control group (leaflet) group (n = 35). The study explored the parents’ knowledge of preoperative care, the follow-up rate, and complications of children with restrictive ventricular septal defect. Results: The score of preoperative care knowledge of the WeChat group (66.9 ± 3.5) was significantly higher than that of the leaflet group (47.3 ± 6.3) (P = .006). Compared with the score of care knowledge at the first visit, the score of the WeChat group at the preoperation was significantly higher (P < .05), whereas the increase in the score of the leaflet group was not significant. The rate of lost follow-up in the WeChat group (0%) was significantly lower than in the leaflet group (16.7%) (P = .02). The complications in the leaflet group were significantly higher than in the WeChat group. Conclusions: Using WeChat to provide preoperative health education to parents of children with restrictive ventricular septal defect can effectively enhance the parents’ knowledge of preoperative care and reduce the occurrence of complications and loss to follow-up.

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A comparison between two educational methods in the rehabilitation of the microstomia in systemic sclerosis: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215519858395 ◽

2019 ◽

Vol 33 (11) ◽

pp. 1747-1756

Author(s):

Claudia Uras ◽

Simona Mastroeni ◽

Stefano Tabolli ◽

Cinzia Masini ◽

Sabatino Pallotta ◽

...

Keyword(s):

Systemic Sclerosis ◽

Confidence Interval ◽

Statistical Significance ◽

Mouth Opening ◽

Controlled Study ◽

Control Group ◽

Educational Materials ◽

Face To Face ◽

Randomized Controlled

Objective: To test the effectiveness of an educational intervention including “face to face” training, compared to a standard information program, to reduce microstomia in women with systemic sclerosis. Design: Single-blind, two-arm, randomized controlled study with a 12-month follow-up period. Setting: Hospital wards of a large Italian dermatological reference center. Subjects: Female inpatients with diagnosis of systemic sclerosis. Interventions: For both groups an information brochure and an audio-visual DVD were developed specifically for the study. The control group was assigned to educational materials alone (i.e. brochures and DVD), while the experimental group, in addition to the same educational materials, received specific “face-to-face” interventions, repeated at each follow-up visit. Main measures: Primary outcome was measurement of the opening of the mouth. Secondary outcomes was the self-reported mouth disability. Results: The intention-to-treat analysis included 63 patients. Compared to the baseline measurement, we observed an increase of the mouth opening of 0.31 cm (95% confidence interval: 0.13–0.49), P = 0.003; in the control group, the increase was 0.13 cm (95% confidence interval: 0.01–0.25), P = 0.06. The difference in improvement between the two groups was not statistically significant ( P = 0.10); however, it reached statistical significance in the per-protocol analysis (39 patients, P = 0.02). Conclusion: Face-to-face nursing rehabilitation training seems to improve microstomia to a greater extent, when compared to a standard intervention based only on written and audio-visual materials.

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The Effect of Acupuncture and Physiotherapy on Patients with Knee Osteoarthritis: A Randomized Controlled Study

January 2018 - Pain Physician ◽

10.36076/ppj.2021/24/e269 ◽

2021 ◽

pp. E269-E278

Author(s):

Sevgi Gumus Atalay

Keyword(s):

Clinical Trial ◽

Knee Osteoarthritis ◽

Functional Status ◽

Acupuncture Group ◽

Controlled Study ◽

Randomized Controlled ◽

Sf 36 ◽

Tertiary Center ◽

Significant Difference

Background: Osteoarthritis is the most prevalent form of joint disease, and the most common location is the knee. Objectives: The aim of this study was to determine the effect of acupuncture treatment and physiotherapy on pain, physical function, and quality of life (QOL) in patients with knee osteoarthritis (KOA). Study Design: This study was a prospective, randomized, controlled clinical trial. Settings: The research took place in the interventional pain unit of a tertiary center in a university hospital. Methods: One hundred patients with KOA were randomly divided into the acupuncture group and the physiotherapy group. Both treatments were given in 12 sessions over 6 weeks. Thirteen acupuncture points were selected for the knee. Local points were GB34, SP10, SP9, ST36, ST35, ST34, EX-LE2, EXLE5, EXLE4, and distal (distant) points were defined as KI3, SP6, LI4, and ST41. The Visual Analog Scale (VAS) was used to measure pain intensity. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the 36-Item Short Form Health Survey (SF-36) were used to determine functional status and health-related QOL, respectively. All patients were evaluated at baseline, after the last treatment, and at the 12-week follow-up period. Results: There was no statistically significant difference between the acupuncture group and physiotherapy group in terms of pain, total WOMAC, and SF-36 levels at baseline, after treatment, and at the 12th week after treatment (P > 0.05). Both treatments significantly improved functional status (acupuncture, from 63.8 ± 20.81 to 53.72 ± 19.43; and physiotherapy, from 59.04 ± 21.49 to 52.28 ± 19.54; P < 0.05) and decreased the level of pain assessed by VAS (acupuncture, from 8.32 ± 1.61 to 5.54 ± 2.34; and physiotherapy, from 7.86 ± 1.9 to 5.68 ± 2.42; P < 0.05) at the 12-week follow-up of the study. There was no adverse advent related to therapeutic methods. Limitations: Sham or placebo control groups are lacking in this study. Conclusions: The acupuncture and physiotherapy performed twice weekly for 6 weeks have similar effects with regard to pain, functional status, and QOL. There were no significant differences between the acupuncture and physiotherapy groups in relief of pain, improved functional status, and QOL in the treatment of KOA. Both acupuncture and physiotherapy treatments were found to yield significantly superior results when compared with baseline values. Key words: Knee osteoarthritis, acupuncture, physiotherapy, randomized clinical trial

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Doxycycline Combined with Bortezomib-Cyclophosphamide-Dexamethasone Chemotherapy for Newly Diagnosed Patients with Mayo 2004 Stage II-III Light-Chain Amyloidosis: A Randomized Controlled Multicenter Study

Blood ◽

10.1182/blood-2019-122087 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 1870-1870

Author(s):

Kaini Shen ◽

Yujun Dong ◽

Weijun Fu ◽

Yu Wu ◽

Zhongxia Huang ◽

...

Keyword(s):

Light Chain ◽

Stage Ii ◽

Controlled Study ◽

Control Group ◽

Al Amyloidosis ◽

Randomized Controlled ◽

Hematological Response ◽

Organ Response ◽

To Receive

【Introduction 】There is ongoing unmet need for effective therapies in Mayo 2004 stage II-III amyloid light-chain (AL) amyloidosis patients, who undergo early death due to cardiac dysfunction. Lately, in vitro studies demonstrated that doxycycline could induce disruption of fibril formation in transgenic mouse model of AL amyloidosis. Matched case-control study of standard chemotherapy with or without doxycycline confirmed higher hematological response, cardiac responses and superior survival with doxycycline in AL patients. However, the possible advantage of doxycycline on lower early mortality and better long-term survival has not been evaluated in a randomized controlled clinical trial. We designed a randomized unblinded controlled study to investigate the efficacy and safety of co-administration of oral doxycycline with bortezomib-cyclophosphamide-dexamethasone (BCD) regimen in treatment-naïve AL amyloidosis patients with Mayo 2004 stage II-III disease. 【Methods 】The randomized unblinded controlled study took place in 12 hospitals in China. Eligible participants were adults with a confirmed diagnosis of AL amyloidosis, whose Mayo 2004 stage were II or III. Enrolled patients were randomly allocated to receive either doxycycline combined with BCD or BCD alone as initial treatment. We chose stratified blocked randomization (block size of 4) to ensure Mayo stage II and III were evenly distributed between doxycycline group and control group. For both two groups, patients will receive 1.3mg/m2of subcutaneous bortezomib and 40mg of oral or intravenous dexamethasone on days 1, 8, 15 and 22, and 300mg/m2oral or intravenous cyclophosphamide on days 1, 8 and 15 of a 35-day cycle. This process was repeated for 9 cycles. Doxycycline was given orally 100mg twice daily for the experimental group. The primary endpoint is progression-free survival. Secondary endpoints include overall survival, adverse events, hematological response, organ response and safety of treatment. This trial has been registered with ClinicalTrials.gov (number NCT03401372) and recruitment and follow-up are ongoing. We planned to enroll a total of 140 participants. 【Results 】Between April 21st, 2018 and June 30th, 2019, 111 patients were enrolled and randomly assigned to receive doxycycline plus BCD (n=56) or BCD alone (n=55) (Figure 1). The baseline characteristics were shown in Table 1. The median age was 61 (range, 41-78) years with a male: female ratio of 1.64:1. Mayo 2004 stage II disease was present in 28 patients in the control group and 29 patients in the doxycycline group. Mayo 2004 stage III disease was present in 27 patients in the control group and 27 patients in the doxycycline group. The median cTnI was 0.10 (range, 0-1.92) μg/L, NT-proBNP 3647 (range, 271-20507) pg/mL, and dFLC 205.30 (50.28-791.90) mg/L, with no significant difference between either group. Organ involvement included the heart (100%), kidney (61.3%), liver (14.4%), peripheral nerves (10.8%) and gastrointestinal tract (5.4%). The percentage of hepatic involvement and 24-hour urine protein were higher in the doxycycline group. The median duration of doxycycline was 5.9 months. Only one patient discontinued doxycycline due to toxicity (Grade 2 rash). Till now, the median follow-up time was 6.1 months and no patients were lost to follow-up. Fourteen patients have completed 9 cycles of chemotherapy. In total, 22 patients died and disease progression occurred in 3 patients. Two patients discontinued treatment due to withdrawal of consent and one of them proceeded to autologous stem cell transplantation. Three patients discontinued study drug owing to unacceptable diarrhea and received second-line treatment based on ixazomib or melphalan afterwards. The grade 3/4 adverse effects were developed in 8 patients (1 infection, 1 mucositis and 6 diarrhea) in the control group and 6 patients (1 infection, 1 arrhythmia, 1 kidney dysfunction and 3 diarrhea) in the doxycycline group. 【Conclusions 】Our data suggested that addition of doxycycline to standard bortezomib-based chemotherapy was an tolerable regimen for treating patients with AL amyloidosis. If this protocol could significantly improve survival and organ response needs to be confirmed with further follow-up. Disclosures No relevant conflicts of interest to declare.

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Impact of Testing on Sexually Transmitted Infections among Female Brothel Sex Workers in Bangladesh: A Randomized Controlled Trial

American Journal of Tropical Medicine and Hygiene ◽

10.4269/ajtmh.20-0942 ◽

2021 ◽

Author(s):

Asad Islam ◽

HongQi Alexis Tan ◽

Claire C. Bristow ◽

Md Golam Hasnain ◽

Russell Smyth ◽

...

Keyword(s):

Sexually Transmitted Infections ◽

Sex Workers ◽

Controlled Trial ◽

Intervention Group ◽

Controlled Study ◽

Baseline Survey ◽

Control Group ◽

Sexually Transmitted ◽

Randomized Controlled

Past studies that have designed interventions to reduce the prevalence of sexually transmitted infections (STIs) have typically provided onsite treatment to sex workers who tested positive, which were expensive and difficult to implement. The purpose of this study was to examine the effect of an intervention which tested for STIs and provided information on the closest treatment facility on reducing the prevalence of STIs among female brothel-based sex workers (BSWs) in Bangladesh. The study adopted a pre–post interventional design as well as a randomized controlled study design. A baseline sample and follow-up urine sample were collected to evaluate the prevalence of STIs among participants in the treatment, but not control group. A baseline survey and interviews were also conducted for both the groups. The study found a nonsignificant reduction from baseline to follow-up in STI prevalence among intervention participants (adjusted odds ratio [aOR]: 0.74; 95% CI: 0.38, 1.45). However, the participants in the intervention group were significantly more likely to have a repeat client (aOR: 1.60; 95% CI: 1.12, 2.29) and nonsignificantly less likely to engage with a client suspected of having an STI (aOR: 0.62; 95% CI: 0.39, 1.00) than participants in the control group. The intervention testing of STIs and providing information to the positive cases about nearest treatment facilities were not effective in reducing the prevalence of STIs among BSWs. Further study of the clinical and behavioral impacts of such efforts to reduce STIs among BSWs is warranted.

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Individual brief art therapy can be helpful for women with breast cancer: A randomized controlled clinical study

Palliative & Supportive Care ◽

10.1017/s147895150900011x ◽

2009 ◽

Vol 7 (1) ◽

pp. 87-95 ◽

Cited By ~ 54

Author(s):

Karin Egberg Thyme ◽

Eva C. Sundin ◽

Britt Wiberg ◽

Inger Öster ◽

Sture Åström ◽

...

Keyword(s):

Breast Cancer ◽

Art Therapy ◽

Rating Scales ◽

Psychiatric Symptoms ◽

Therapy Group ◽

Postoperative Radiotherapy ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled

ABSTRACTObjective:Recent research shows that almost every second woman with breast cancer is depressed or has anxiety; the risk for younger women is even higher. Moreover, research shows that women are at risk for developing depression, also a threat for women with breast cancer. The aim of this randomized controlled clinical trial was to study the outcome of five sessions of art therapy given at a 5-week period of postoperative radiotherapy.Methods:The participants were between 37 and 69 years old; six participants in each group were below 50 years of age. Half of the participants (n = 20) received art therapy and the other half (n = 21) were assigned to a control group. At the first measurement, at least 17% (n = 7) of the participants medicated with antidepressants. Data were collected before and after art therapy and at a 4-month follow-up using self-rating scales that measure self-image (the Structural Analysis of Social Behaviour) and psychiatric symptoms (the Symptom Check List–90).Results:At follow-up, significant lower ratings of depression, anxiety, and somatic symptoms and less general symptoms were reported for the art therapy group compared to the control group. The regression analysis showed that art therapy relates to lower ratings of depression, anxiety, and general symptoms; chemotherapeutic treatment predicts lower depressive symptoms; in contrast to axilliary surgery and hormonal treatment as well as being a parent predicts higher ratings of anxiety and general symptoms.Significance of results:The conclusion suggests that art therapy has a long-term effect on the crisis following the breast cancer and its consequences.

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Single or two instillations of pirarubicin as prophylaxis for recurrence after transurethral resection of Ta and T1 transitional cell bladder cancer: A prospective, randomized controlled study.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.5_suppl.lba266 ◽

2012 ◽

Vol 30 (5_suppl) ◽

pp. LBA266-LBA266

Author(s):

Takashi Saika ◽

Tomoyasu Tsushima ◽

Yasutomo Nasu ◽

Hiromi Kumon ◽

Keyword(s):

Transurethral Resection ◽

Intravesical Instillation ◽

Randomized Controlled Study ◽

Controlled Study ◽

Control Group ◽

Randomized Controlled ◽

Group A ◽

Muscle Invasive ◽

Group B

LBA266 Background: Although single intravesical instillation chemotherapy immediately after transurethral resection (TUR) is the standard treatment for non-muscle-invasive bladder tumors, 40% to 80% of tumors show intravesical recurrence. In this prospective randomized controlled study, we try to evaluate the prophylactic efficacy and safety of twice intravesical instillation using pirarubicin (THP) administered immediately after TUR and on the next day following TUR by comparison with single instillation immediately after TUR. Methods: Between 2005 and 2009, 250 patients with Ta and T1 solitary bladder carcinoma were enrolled in this study. Patients were randomized into two groups. Group A patients were treated with two intravesical instillations of THP 30 mg/50 ml saline immediately after TUR and within 24 hours. Group B patients were treated with single instillation of the same dose immediately after TUR as a control group. The primary endpoint was duration to the first recurrence, and the secondary endpoint was safety. Results: The enrollment was closed on 2009, and the follow-up phase is in process. Of the 250 patients, 125 in Group A and 125 in Group B could be evaluated as full analysis set. One hundred eight male and 17 female were in Group A, on the other hands, one hundred five male and 20 female were in Group B. Eighty-six cases (69%) in group A, and 88 cases (70%) in group B were primary tumor. Fifty-seven cases (46%) in group A, and 56 cases (45%) in group B were small tumor (less than 10mm). There was no difference between backgrounds of both groups. The randomization worked well. In this ad interim report, median follow up was 48 months. Two-year recurrence-free rates were 76.8% in group A and 67.5% in group B. Adverse reactions related to instillation were observed in about 20% of the patients. These toxicities were mild and transient. Only the incidence of frequency in group A was higher than that in group B (20% vs. 8%, p=0.0106). Conclusions: Intravesical instillation of THP 30 mg twice within 24 hours after TUR was effective as prophylactic therapy for non-muscle-invasive cancer with tolerable toxicity problems.

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