• Title/Summary/Keyword: Clinical trial,

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Late-term effects of hypofractionated chest wall and regional nodal radiotherapy with two-dimensional technique in patients with breast cancer

  • Yadav, Budhi Singh;Bansal, Anshuma;Kuttikat, Philip George;Das, Deepak;Gupta, Ankita;Dahiya, Divya
    • Radiation Oncology Journal
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    • v.38 no.2
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    • pp.109-118
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    • 2020
  • Purpose: Hypofractionated radiotherapy (RT) is becoming a new standard in postoperative treatment of patients with early stage breast cancer after breast conservation surgery. However, data on hypofractionation in patients with advanced stage disease who undergo mastectomy followed by local and regional nodal irradiation (RNI) is lacking. In this retrospective study, we report late-term effects of 3 weeks post-mastectomy hypofractionated local and RNI with two-dimensional (2D) technique in patients with stage II and III breast cancer. Methods: Between January 1990 and December 2007, 1,770 women with breast cancer who were given radical treatment with mastectomy, systemic therapy and RT at least 10 years ago were included. RT dose was 35 Gy/15 fractions/3 weeks to chest wall by two tangential fields and 40 Gy in same fractions to supraclavicular fossa (SCF) and internal mammary nodes (IMNs). SCF and IMNs dose was prescribed at dmax and 3 cm depth, respectively. Chemotherapy and hormonal therapy was given in 64% and 74% patients, respectively. Late-term toxicities were assessed with the Radiation Therapy Oncology Group (RTOG) scores and LENT-SOMA scales (the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales). Results: Mean age was 48 years (range, 19 to 75 years). Median follow-up was 12 years (range, 10 to 27 years). Moderate/marked arm/shoulder pain was reported by 254 (14.3%) patients. Moderate/marked shoulder stiffness was reported by 219 (12.3%) patients. Moderate/marked arm edema was seen in 131 (7.4%) patients. Brachial plexopathy was not seen in any patient. Rib fractures were noted in 6 (0.3%) patients. Late cardiac and lung toxicity was seen in 29 (1.6%) and 23 (1.3%) patients, respectively. Second malignancy developed in 105 (5.9%) patients. Conclusion: RNI with 40 Gy/15 fractions/3 weeks hypofractionation with 2D technique seems safe and comparable to historical data of conventional fractionation (ClinicalTrial.gov Registration No. NCT04175821).

The Effect of Sa-am Acupuncture Simjeongkyeok Treatment for Major Symptom of Hwa-byung (화병의 핵심증상에 대한 사암침 심정격 치료의 효과)

  • Jeong, In-Chul;Lee, Sang-Ryong;Park, Yang-Chun;Hong, Kwon-Eui;Lee, Young-Koo;Kang, Wee-Chang;Choi, Sun-Mi;Choi, Kang-Wook;Oh, Dal-Seok;Park, Ji-Eun
    • Journal of Oriental Neuropsychiatry
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    • v.19 no.1
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    • pp.1-18
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    • 2008
  • The purpose of this research is to examine the effect of Simjeongkyeok Sa-am acupuncture treatment for major symptoms of Hwa-byung. Method : In this randomized, single blind, placebo-controlled study, we compared Simjeongkyeok acupuncture with Sham acupuncture in the treatment for major symptoms of Hwa-byung. Likert scale for major symptom of Hwa-byung was measured as the 1st evaluative instrument, and STAXI-K, STAI-K, BDI-K and HRV were also measured as the 2nd evaluative instrument at the before treatment and after treatment. Results : In comparison of Likert scale for major symptoms, total score of after treatment decreased significantly at each point on both groups, but there was no significant difference between both groups. In comparison of STAXI-K, STAI-K, BDI-K, there was no significant difference in variation of score between both groups. But Simjeongkyeok group showed higher ratio variation of STAXI expression than that of Sham group, Also on subjects whose main complaint symptom were burning sensation and whose pattern identification were Qizhi, Simjeongkyeok group showed higher variation of Likert scale score and BDI-K than that of Sham group. The significance was border line around. Conclusion : We considered that Shimjeongkeok treatment will he likely to he recommended for treating Hwa-byung, especially on subjects in each group whose main complaint symptom were burning sensation or whose pattern identification were Qizhi. Also it may also be effective on the management of anger expression.

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Study on Antiangiogenic and Antitumor Activities of Processed Rhus verniciflua Stokes extract (법제 옻나무 추출물의 혈관형성저해 및 항암효과에 관한 연구)

  • Choi, Won-Cheol;Lee, Jae-Ho;Lee, Eun-Ok;Lee, Hyo-Jung;Yoon, Sung-Woo;Ahn, Kyoo-Seok;Kim, Sung-Hoon
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.20 no.4
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    • pp.825-829
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    • 2006
  • Rhus verniciflua Stokes has been used for treatment of blood stasis and abdominal mass in Oriental medicine. Rhus verniciflua Stokes has been experimentally reported to exert antioxidant, antiproliferative, antithrombotic and apoptotic activities. In the present study, the antiangiogenic and in vivo antitumor activities of aqueous extract of processed Rhus verniciflua Stokes (Nexia) by heat were examined to elucidate its anticancer mechanism. Nexia showed weak cytotoxiicty against human umbilical vein endothelial cells (HUVEC) and Lewis lung carcinoma cells (LLC) with IC50 of${\sim}200\;{\mu}g/ml\;and\;>200\;{\mu}g/ml$, respectively. Nexia significantly inhibited the proliferation and migratory activity in vascular endothelial growth factor(VEGF) treated HUVEC. Furthermore, Nexia effectively suppressed the tumor volume in A549 nonsmall lung cancer bearing athymic nude mice, CanN. Cg-Foxn 1nu/CrljBgi up to 40.7% as well as tumor weight incised from LLC cells innoculated into the flank of C57BL/6 mice up to -50% compared with untreated control at a dose of 300 mg/kg. Taken together, these results suggest that processed Rhus verniciflua Stokes may inhibit the growth of Lewis lung carcinoma cells partly via inhibition of angiogenesis and can be potently applied to angiogenesis dependent cancers. However, it still needs a further research on molecular mechanism, angiogenesis animal study and clinical trial in future.

The Effects of distilled Astragali Radix Herbal Acupuncture on the Heart Rate Variability(HRV) (황인 약침이 정산인의 심박변이도(HRV)에 미치는 영향)

  • Lim, Sung-Taek;Kim, Lak-Hyung;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Oriental Neuropsychiatry
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    • v.19 no.1
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    • pp.107-124
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    • 2008
  • We investigated the effects of distilled Astragali Radix Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Astragali Radix Herbal Acupuncture on the balance of the autonomic nervous system. Methods : We investigated on 61 healthy volunteers consisted of 31 subjects in experiment(distilled Astragali Radix Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 31 subjects in experiment group were injected distilled Astragali Radix Herbal Acupuncture at GB21(Kyonjong) and 30 subjects in control group were injected Normal Saline at GB21(Kyonjong). except of 2 subjects(in control group) who can't be measured and 10 subjects(6 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 25 subject in experiment group and 24 subject in control group are studied. We measured HRV by PolyG-I on 7 times : before and after injection per 5 minutes during 30 minutes. The SPSS 10.0 for windows was used to analyze the data and the paired t test(in group) and Student t test(between two groups) were used to verify the result. Results : I. After distilled Astragali Radix Herbal Acupuncture injection, SDNN is significantly high from 5 minute to 10 minute and from 15 minute to 30 minute, Complexity is significantly low from 20 minute to 30minute. HRV index is significantly mgb for first 20 minute and from 25 minute to 30 minute, RMSSD is significantly high only from 15 minute to 20 minute. 2. HRV index of distilled Astragali Radix Herbal Acupuncture Group significantly increased from 25 minute to 30 minute, pNN50 of distilled Astragali Radix Herbal Acupuncture Group significantly decreased from 25 minute to 30 minute and RMSSD of distilled Astragali Radix Herbal Acupuncture Group significantly increased from 25 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Astragali Radix Herbal Acupuncture injection, Ln(TP) is significantly high from 5 minute to 10 minute and from 15 minute to 30 minute. Ln(VLF) is significantly high after 5 minute, Ln(LF) is significantly high after 15 minute and Ln(HF) is significantly high from 5 minute to 10 minute and 25 minute to 30 minute, but significantly low for first 5 minute and from 10 minute to 20 minute. Normalized LF is significantly high after 20 minute and Normalized LF is significantly low after 20 minute. Conclusions : The results suggest that distilled Astragali Radix Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system within normal range. This result is derived from that parasympathetic nervous system was continuously activated and sympathetic nervous system was activated a little later.

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Comparison of the Change in the Prevalence and Intensity of Schistosoma haematobium Infection Between High and Low Prevalence Areas of White Nile State, Sudan

  • Cha, Seungman;Hong, Sung-Tae;Lee, Jin-Su;Jeong, Hoo Gn;Kwon, In-Sun;Saed, Abd Al Wahab;Elhag, Mousab Siddig;Ismail, Hassan Ahmed Hassan Ahmed;Amin, Mutamad;Lee, Young-Ha
    • Parasites, Hosts and Diseases
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    • v.58 no.4
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    • pp.421-430
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    • 2020
  • This study aimed to investigate whether mass drug administration (MDA) intervention has an equivalent effect on reducing the prevalence and intensity of Schistosoma haematobium infection regardless of the baseline values. A repeated cross-sectional survey was performed targeting students of 12 primary schools in Al Jabalain and El Salam districts of White Nile State, Sudan, at both 1 week before and 8 months after the MDA. Prior to the baseline survey, schoolaged children in Al Jabalain had received MDA interventions twice in 4 years, while those in El Salam had not. The baseline prevalence was 9.1% in Al Jabalain and 35.2% in El Salam, which were reduced to 1.8% and 5.5% at 8 months after the MDA, respectively. The corresponding reduction rates were 80.3% and 84.4%, not significant difference between both districts. However, changes in the geometric mean intensity (GMI) of egg counts were significantly different between both districts. The baseline GMIs were 14.5 eggs per 10 ml of urine (EP10) in Al Jabalain and 18.5 EP10 in El Salam, which were reduced to 7.1 and 11.2 EP10 after treatment, respectively. The corresponding reduction rates were 51.0% and 39.5%. In conclusion, MDA interventions were found to bring about similar relative reduction in prevalence regardless of the baseline value; however, the relative reduction in infection intensity was more salient in the district with a low baseline value for both prevalence and intensity. This clearly points to the importance of repeated MDA interventions in endemic areas, which will eventually contribute to schistosomiasis elimination.

Efficacy and Safety of Miniscalpel Acupuncture, Non-Steroidal Anti-Inflammatory Drugs or Combined Treatment for Chronic Neck Pain: An Assessor-Blinded Randomized Controlled Pilot Study (만성 경항통(목부위 통증)의 도침요법, 진통제, 복합치료의 효능 및 안전성 연구)

  • Gong, Han Mi;Jun, Seungah;Chung, Yeon-Joong;Kim, Ju-Ran;Lee, Jung Hee;Lee, Hyun-Jong;Park, Chung A;Kim, Jae Soo
    • Korean Journal of Acupuncture
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    • v.37 no.1
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    • pp.14-23
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    • 2020
  • Objectives : We investigated the efficacy and safety of miniscalpel acupuncture (MA) treatment combined with non-steroidal anti-inflammatory drugs (NSAIDs) for chronic neck pain (CNP) in an assessor-blinded randomized controlled pilot trial to establish a basis for larger-scale randomized controlled studies on this subject. Methods : Participants (n=36) were recruited and randomly allocated to the MA group, NSAIDs and combined treatment group. The MA group received MA three times over three weeks. The NSAIDs group was administered orally with zaltoprofen 80mg t.i.d. over three weeks. The combined treatment group received MA and zaltoprofen in the same manner as MA and NSAIDs groups. The primary outcome was pain as assessed by a visual analogue scale (VAS) and the secondary outcomes were assessed using the Neck Disability index (NDI), EuroQol 5-dimension questionnaire (EQ-5D), and Patients' Global Impression of Change scale (PGIC). Assessments were made at week 0 (baseline), 1, 2, 3 (primary end point) during treatment and at week 7 (4 weeks after the end of treatment). Results : 35 participants completed the study. No serious adverse event occurred and blood test results were within normal limits. The improvement of VAS and NDI was significantly greater in combined and MA group than that in NSAIDs group (p<0.017). The combined group showed better outcomes in EQ-5D at visit 2 and 5, in PGIC at visit 4 than the NSAIDs group (p<0.017). No significant differences were found between combined and MA group. Conclusions : Our results suggest that both combined and MA group can be more effective in improving pain control than NSAIDs group. A large-scale clinical study is warranted to further clarify these findings.

Comparison of Dental Biofilm Reduction between Rolling Method and Modified Stillman Method (회전법과 변형스틸맨법의 치면세균막 감소 효과 비교)

  • Han, Ye-Seul;Lim, Soon-Ryun;Cho, Young-Sik
    • Journal of dental hygiene science
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    • v.12 no.6
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    • pp.660-665
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    • 2012
  • The purpose of this study was to use basic data of dental hygiene curriculum by comparing the rolling method and modified stillman method. Plaque measurement method, Q-ray examination of the clinical utilization value shall review. True experimental design is randomized controlled trial to the intervention group and the control group. Measurements are plaque control record (PCR; O'Leary index) measurements and Quantitative Light induced fluorescnece Digital (QLFD) shooting as a pre-test was conducted. Intervention group is modified stillman method, control group is rolling method. Intervention after 5 weeks, PCR measurement and QLFD shooting was carried out as a post-test. Rolling method and modified stillman method plaque reduction did not differ. Intervention before and after the results of the comparison showed reduced plaque score after brushing law education. Also, Plaque reduction differences were more pronounced modified stillman method than rolling method. PCR and QLFD values of the correlation was not confirmed but SPS Score and the lower value of the ${\Delta}R$ value of the correlation. Plaque of maturity tooth that are not observed visually.

Affected Model of Indoor Radon Concentrations Based on Lifestyle, Greenery Ratio, and Radon Levels in Groundwater (생활 습관, 주거지 주변 녹지 비율 및 지하수 내 라돈 농도 따른 실내 라돈 농도 영향 모델)

  • Lee, Hyun Young;Park, Ji Hyun;Lee, Cheol-Min;Kang, Dae Ryong
    • Journal of health informatics and statistics
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    • v.42 no.4
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    • pp.309-316
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    • 2017
  • Objectives: Radon and its progeny pose environmental risks as a carcinogen, especially to the lungs. Investigating factors affecting indoor radon concentrations and models thereof are needed to prevent exposure to radon and to reduce indoor radon concentrations. The purpose of this study was to identify factors affecting indoor radon concentration and to construct a comprehensive model thereof. Methods: Questionnaires were administered to obtain data on residential environments, including building materials and life style. Decision tree and structural equation modeling were applied to predict residences at risk for higher radon concentrations and to develop the comprehensive model. Results: Greenery ratio, impermeable layer ratio, residence at ground level, daily ventilation, long-term heating, crack around the measuring device, and bedroom were significantly shown to be predictive factors of higher indoor radon concentrations. Daily ventilation reduced the probability of homes having indoor radon concentrations ${\geq}200Bq/m^3$ by 11.6%. Meanwhile, a greenery ratio ${\geq}65%$ without daily ventilation increased this probability by 15.3% compared to daily ventilation. The constructed model indicated greenery ratio and ventilation rate directly affecting indoor radon concentrations. Conclusions: Our model highlights the combined influences of geographical properties, groundwater, and lifestyle factors of an individual resident on indoor radon concentrations in Korea.

A study on the minimal acupuncture using a modified guide tube for Korean female participants familiar with acupuncture therapy (침치료에 익숙한 한국의 여자 임상시험 피험자를 대상으로 한 침관 변형을 통한 Minimal acupuncture 경험)

  • Roh, Jin-Ju;Jung, Su-Kyoung;Choi, Min-Sun;Choi, Sun-Mi;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.20 no.3
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    • pp.200-212
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    • 2007
  • Purpose: To find objective validity of minimal acupuncture using a modified guide tube as a method to verify the effect of acupuncture. Methods: Subjects of this study were participants of a randomized clinical trial which was practiced to verify the effect of acupuncture on postmenopausal hot flash. There were 2 arms of treatment, one's for active acupuncture group(AG) with manipulation and De qi, the other's for minimal acupuncture group(MG) using a modified guide tube which was designed to give minimal stimulation to the patient. After 8 weeks' treatment followed by 4 weeks' observation, participants were asked to fill in self-report forms on their education, previous experiences of acupuncture, original idea on the efficacy of acupuncture and recognition of blinding. Results: 19 participants of 26 in AG and 19 of 26 in MG completed the self-report form. There was no difference between AG and MG in their education(p=0.5976, Fisher exact test) and previous experiences of acupuncture(p=0.9999, Fisher exact test). In their original ideas on the efficacy of acupuncture, most of AG and MG respondents have been thought that acupuncture is very effective or quite effective, and there was no difference between 2 groups(p=0.5065). 16 of 19 in AG and 14 of 19 in MG believed that they underwent more effective way, there was no statistical difference between 2 groups(p=0.6928, Fisher exact test). Participants believed in undergoing more effective way not because they recognized treatment method, but they were satisfied with the effectiveness of treatment retrospectively. Conclusion: As the result of this study, these authors suggest that minimal acupuncture using a modified guide tube is acceptable as a method to verify the effect of acupuncture in acupuncture-familiar Korean culture. Also further studies on the stimulation-specific effect of minimal acupuncture are demanded.

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Study on Application of Skin Care Cosmetic and Stabilization of Idebenone by Forming Niosome Vesicle Technology

  • Kim, In-Young
    • Journal of the Korean Applied Science and Technology
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    • v.36 no.2
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    • pp.592-599
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    • 2019
  • This study is to stabilize insoluble and unstable active ingredient which is Idebenone (INCI name: hydroxydecyl ubiquinone) in a multi-lamellar vesicle (MLV) and to stabilize it in the skin care cosmetics. Idebenone is good effective raw material in the treatment of Alzheimer's disease in the medical field and a powerful antioxidant in dermatology. It is well known as a substance that inhibits the formation of melanin and cleans the skin pigment. However, it did not dissolve in any solvent and it was difficult to apply in cosmetic applications. Niosome vesicle was able to develop a nano-particle by making a multi-layer of idebenone encapsulated with a nonionic surfactant, hydrogenated lecithin and glycine soja (soybean) sterols and passing it through a high pressure microfluidizer. Idebenone niosome vesicle (INV) has been developed to have the ability to dissolve transparently in water and to promote transdermal penetration. The appearance of the INV was a yellowish liquid having specific odor, and the particle size distribution of INV was about 10~80 nm. The pH was 5~8 (mean=6.8). This capsulation with idebenone was stored in a $45^{\circ}C$ incubator for 3 months and its stability was observed and quantitatively measured by HPLC. As a result, the stability of the sample encapsulated in the niosome vesicle (97.5%) was about 66.3% higher than that of the non-capsule sample of 32.5%. Idebenone 1% INV was used for the efficacy test and clinical trial evaluation as follows. The anti-oxidative activity of INV was 38.2%, which was superior to that of 12.8% tocopherol (control). The melanin-reducing effect of B16 melanoma cells was better than INV (17.4%) and Albutin (control) (9.6%). Pro-collagen synthesis rate was 128.2% for INV and 89.3% for tocopherol (control). The skin moisturizing effect was 15.5% better than the placebo sample. The elasticity effect was 9.7% better than the placebo sample. As an application field, INV containing 1% of idebenone is expected to be able to develop various functional cosmetic formulations such as skin toner, ampoule essence, cream, eye cream and sunblock cream. In addition, it is expected that this encapsulated material will be widely applicable to emulsifying agents for skin use in the pharmaceutical industry as well as the cosmetics industry.