Randomized Study of Adjuvant Chemotherapy for Head and Neck Cancer

1985 ◽  
Vol 93 (6) ◽  
pp. 712-717 ◽  
Author(s):  
Paul Y. Holoye ◽  
Thomas W. Grossman ◽  
Robert J. Toohill ◽  
Larry E. Kun ◽  
Roger W. Byhardt ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Head And Neck ◽  
Standard Therapy ◽  
Statistical Significance ◽  
Randomized Study ◽  
Survival Rates ◽  
Distant Metastases ◽  
Control Group ◽  
Preoperative Irradiation ◽  
Significant Difference

The ability of surgery and radiotherapy to control advanced squamous cell carcinoma of the head and neck has reached its maximal potential. We initiated a randomized, prospective, stratified study of adjuvant chemotherapy. Patients with stage II disease of the pyrlform sinus and stage III and IV disease of the oral cavity, larynx, hypopharynx, oropharynx, nasopharynx, and paranasal sinuses were eligible. Patients were randomized to receive either standard therapy alone or two courses of 5-fluorouracil (B-CMF) chemotherapy prior to and two courses after the completion of standard therapy. Standard therapy consisted of preoperative irradiation followed by radical surgery. Of 133 patients with advanced disease, 83 were included In the study—43 In the chemotherapy group and 40 In the control group. Rates of residual and recurrent disease, as well as distant metastases, were similar for the two groups. The survival rates of patients without persistent disease at the end of treatment showed no significant difference for the two groups. The study has been discontinued because statistical analysis Indicated that the addition of more patients would not materially Increase the statistical significance of the study.

Adjuvant chemotherapy with vincristine, cyclophosphamide, and doxorubicin after radiotherapy in local-regional nasopharyngeal cancer: results of a 4-year multicenter randomized study.

1988 ◽  
Vol 6 (9) ◽  
pp. 1401-1410 ◽  
Author(s):  
A Rossi ◽  
R Molinari ◽  
P Boracchi ◽  
M Del Vecchio ◽  
E Marubini ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Randomized Study ◽  
Nasopharyngeal Cancer ◽  
Distant Metastases ◽  
Undifferentiated Carcinoma ◽  
Treatment Groups ◽  
Distant Failure ◽  
Curative Radiotherapy ◽  
Significant Difference ◽  
Base Of The Skull

To evaluate the effect of adjuvant chemotherapy in patients with local-regional nasopharyngeal carcinoma (NPC) (squamous or undifferentiated) in complete remission at the end of curative radiotherapy (RT) 229 patients were randomized from 1979 to 1983 in a multicenter study to no further therapy (116 patients) or a combination of vincristine, cyclophosphamide, and Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH) (VCA) for six monthly cycles (113 patients). The RT and RT + VCA groups were well balanced for median age (50 v 49 years), histology (undifferentiated carcinoma, 73% v 70%), tumor extent (tumor limited to nasopharynx, 57% v 57%), and nodal extent (negative nodes 26% v 24%, nodes in the lower cervical levels, 17% v 16%). RT was delivered to the nasopharynx, the base of the skull, and bilateral cervical nodes using a split course technique over 10 weeks up to the dose of 60 to 70 Gy in involved sites and 50 Gy to negative nodes. Response to RT was evaluated within 65 days post-RT treatment. Analysis at 48 months did not show significant difference between the two treatment groups in terms of relapse-free survival (RT, 55.8%, RT + VCA, 57.7%, P = .45) and overall survival (RT, 67.3%, RT + VCA, 58.5%, P = .13). The pattern of relapse was similar in the two treatment arms. Distant metastases were the cause of treatment failure in about 50% of relapsing patients. Although the results of the present study did not show any benefit from VCA administered after curative RT, combined systemic chemotherapy should be further explored due to the high incidence of local and distant failure after intensive RT.

Effect of Anemia on Survival of Myocutaneous Flaps in the Pig

1994 ◽  
Vol 111 (4) ◽  
pp. 509-512 ◽  
Author(s):  
Ilsa Schwartz ◽  
Kun Z. Kim ◽  
David H. Thompson ◽  
Thomas F. George ◽  
Patrick M. McQuillan ◽  
...  
Keyword(s):  
Head And Neck ◽  
Latissimus Dorsi ◽  
Survival Rates ◽  
Surgical Flaps ◽  
Control Group ◽  
Oncologic Surgery ◽  
Flap Survival ◽  
Myocutaneous Flaps ◽  
Significant Difference ◽  
Normovolemic Anemia

The decision to transfuse patients after major head and neck reconstructive surgery has been influenced by the dictum that a hematocrit level of 30% or more is necessary for the survival of surgical flaps. Pedicled myocutaneous flaps are among the most frequently used methods of reconstruction after major head and neck oncologic surgery. No studies have addressed the survival of myocutaneous pedicied flaps in anemic animals. In this study survival of latissimus dorsi myocutaneous flaps in pigs was evaluated in anemic and control groups. A total of 26 pigs were randomly divided into two groups. The pigs in the anemic group were exsanguinated to normovolemic anemia (average hematocrit, 19%), followed by elevation of a latissimus dorsi myocutaneous flap. In the control group the same operation was performed without exsanguination. All other variables were kept constant. The flap survival was judged on postoperative3 days 7, and 14 by two evaluators. Ten pigs from each group were found to have 100% flap survival on postoperative day 14. There was no significant difference in mean flap survival rates between two groups for postoperative3 days 7, and 14. It is concluded that normovolemic anemia does not adversely affect the survival of the myocutaneous flaps. This finding may save unnecessary transfusions in postoperative patients.

Adjuvant methotrexate escalated to toxicity for resectable stage III and IV squamous head and neck carcinomas--a prospective, randomized study.

1987 ◽  
Vol 5 (2) ◽  
pp. 278-285 ◽  
Author(s):  
R E Rentschler ◽  
D W Wilbur ◽  
G H Petti ◽  
G D Chonkich ◽  
D A Hilliard ◽  
...  
Keyword(s):  
Overall Survival ◽  
Head And Neck ◽  
Statistical Significance ◽  
Randomized Study ◽  
Disease Free Survival ◽  
Stage Iii ◽  
Hematologic Toxicity ◽  
Head And Neck Carcinomas ◽  
Significant Difference

To determine if adjuvant methotrexate (MTX), escalated weekly to toxicity, could improve disease-free survival (DFS) and overall survival by preventing recurrent disease, 60 patients with potentially resectable stage III or IV squamous head and neck carcinomas were stratified by primary site, stage, and nutritional status, then randomized by pairs to receive or not receive adjuvant MTX. All received standard surgery and postoperative radiation therapy. Five patients were taken off study because of unresectability at the time of surgery, leaving 55 evaluable patients. There were no statistically significant imbalances in known prognostic factors between the two treatment arms. MTX was begun at 40 mg/m2 and escalated 10 mg/m2 weekly (four doses preoperatively; four doses postoperatively, preradiation therapy; eight doses postradiation therapy) to mucosal or hematologic toxicity. The median peak MTX dose achieved was 80 mg/m2. Although three patients were hospitalized with MTX toxicity, none died of MTX toxicity. No patient receiving MTX had disease progression during treatment, and there was no increase in postoperative complications. Thirty-two patients died (median survival, 19 months); 23 patients are alive with median follow-up of 43 months. There was no statistically significant difference in actuarial DFS (P = 1.0) or overall survival (P = .61). Although patients on the MTX arm appeared to have less local and regional recurrences at first recurrence (thus more distant metastases), this did not reach statistical significance (P = .06). There was no significant difference between the sites of recurrence at death or last follow-up (P = .38).

scholarly journals Clinical Study on the Efficacy and Safety of Arginine Administered Orally in Association with Other Active Ingredients for the Prevention and Treatment of Sarcopenia in Patients with COVID-19-Related Pneumonia, Hospitalized in a Sub-Intensive Care Unit

Healthcare ◽  
2022 ◽  
Vol 10 (1) ◽  
pp. 162
Author(s):  
Carolina Bologna ◽  
Eduardo Pone
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Standard Therapy ◽  
Vastus Lateralis ◽  
Statistical Significance ◽  
Randomized Study ◽  
Control Group ◽  
Average Value ◽  
Prevention And Treatment ◽  
Handgrip Test

In order to evaluate the efficacy of oral supplementation with 3 g of arginine per day associated with creatine, L-carnitine, aspartic acid, magnesium, selenium and vitamins C and E (Argivit© Aesculapius Farmaceutici) in the prevention and treatment of sarcopenia in patients with COVID-19-related pneumonia, we conducted a parallel randomized study comparing it with standard therapy alone. Forty patients on standard therapy plus supplementation were compared with a control group of 40 patients, all hospitalized at the sub-intensive care unit of the Del Mare Hospital in Naples, with a clinical diagnosis of SARS-CoV-2 infection and COVID-19 pneumonia. Muscle strength was assessed with the handgrip test and muscle ultrasound. Arginine-supplemented patients had an average grip strength of 23.5 at the end of hospitalization compared with 22.5 in the untreated group with less reduction, showing statistical significance (p < 0.001). In the same way, the thickness of the vastus lateralis quadriceps femoris muscle measured at the end of hospitalization showed less reduction on ultrasound, with a higher average value in the group receiving treatment than in the group of patients without supplementation (p < 0.001). Upon discharge there was a 58.40% reduction in ventilation days in patients with arginine supplementation compared with the control group.

scholarly journals The influence of the Kinesio Taping on selected ultrasonography measurements, and quality of life in patients with rotator cuff lesions

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Aneta Bac ◽  
Magdalena Wróbel ◽  
Katarzyna Ogrodzka-Ciechanowicz ◽  
Edyta Michalik ◽  
Anna Ścisłowska-Czarnecka
Keyword(s):  
Quality Of Life ◽  
Rotator Cuff ◽  
Statistical Significance ◽  
Control Group ◽  
Subacromial Space ◽  
Kinesio Taping ◽  
Significant Difference ◽  
Rotator Cuff Lesions ◽  
Significant Change

Abstract The assessment of the six-week influence of Kinesio Taping combined with a rehabilitation on selected ultrasonography measurements, the level of disability, and the quality of life in patients with rotator cuff lesions. 60 participants were randomly assigned into a taping group (KT combined with a six-week rehabilitating protocol) and a control group (only rehabilitation protocol). In all patients the following assessments were performed twice: USG, UEFI and NHP questionnaires. In the examination of the subacromial space and the subacromial bursa in the taping group, no statistical significance was observed. A statistically significant change in the thickness of the muscles was obtained only for the thickness of the infraspinatus in the taping group. A statistically significant change was obtained in the assessment of tendinopathy only for the supraspinatus muscle in both groups. Within both groups a statistically significant difference was observed in the average UEFI and NHP scores; however, the differences in the scores obtained between the groups were not statistically significant. The use of KT with a rehabilitation program did not yield statistically significantly better results in the improvement of selected shoulder region indicators, the function of the upper limb and the quality of life.

scholarly journals The role of peripheral type 2 innate lymphoid cells in bronchiolitis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yong-Jun Tang ◽  
Li-Li Xie ◽  
Xiang-Rong Zheng ◽  
Chen-Tao Liu ◽  
Xia Wang
Keyword(s):  
Statistical Significance ◽  
Serum Levels ◽  
Innate Lymphoid Cells ◽  
Lymphoid Cells ◽  
Orphan Receptor ◽  
Control Group ◽  
Interleukin 5 ◽  
Healthy Infants ◽  
Significant Difference

AbstractOur aim was to detect type 2 innate lymphoid cells (ILC2s)-related cytokines of infants with bronchiolitis by using Elisa, Liquidchip technology and RT-PCR and investigated its correlation with bronchiolitis. We recruited 26 infants with bronchiolitis and 20 healthy infants as control from Xiangya Hospital. Compared to the control group, the serum levels of interleukin-5 (IL-5) [41.99 (21.11) vs 25.70 (19.64)], IL-9 [27.04 (37.51) vs 8.30 (0.54)], IL-13 [184.05 (132.81) vs 121.75 (176.13)], IL-33 [83.70 (46.69) vs 11.23 (55.31)] and thymic stromal lymphopoietin (TSLP) [31.42 (5.41) vs 28.76 (2.56)] were significantly increased in infants with bronchiolitis (P < 0.05), while the level of IgE had no significant difference between the two groups [19.05 (14.15) vs 14.85 (20.2), P > 0.05]. The mRNA expression of IL-17RB (9.83 ± 0.35 vs 9.19 ± 0.58), TSLP (16.98 ± 2.12 vs 15.07 ± 2.25), retinoid acid receptor related orphan receptor α (7.18 ± 0.71 vs 5.46 ± 1.09) and trans-acting T-cell-specific transcription factor 3 (4.86 ± 0.66 vs 4.19 ± 0.90) were significantly increased in infants with bronchiolitis versus the control group (P < 0.05), while there was no statistical significance for suppression of tumorigenicity 2 (5.59 ± 0.68 vs 5.41 ± 0.87, P > 0.05). Our findings suggested that ILC2s possibly play a specific role in immunopathology of bronchiolitis.

A prospective randomized study to assess the efficacy of post-operative nasal medication after endonasal surgery

1995 ◽  
Vol 109 (7) ◽  
pp. 618-621 ◽  
Author(s):  
Paul D. R. Spraggs ◽  
Marcelle Macnamara ◽  
Theo Joseph
Keyword(s):  
Randomized Study ◽  
Correlation Coefficients ◽  
Control Group ◽  
Time Intervals ◽  
Treatment Groups ◽  
Ephedrine Hydrochloride ◽  
Patent Airway ◽  
Significant Difference ◽  
Blood Clots ◽  
Betamethasone Sodium Phosphate

AbstractPost-operative nasal medications are commonly used following routine septal or turbinate surgery but their efficacy in removing blood clots, improving the sensation of a patent airway and promoting healing are unknown. This prospective randomized trial of patients undergoing septal and/or turbinate surgery assessed the efficacy of three commonly used nasal medicines, 0.5 per cent ephedrine hydrochloride nasal drops, betamethasone sodium phosphate (Betnosol®) nose drops and alkaline nasal douches, in producing the sensation of a patent airway in the 14 days following surgery. Ninety-seven patients were randomized into the three treatment groups and a control group who received no nasal medication. Patients assessed their nasal patency by means of a visual analogue scale (VAS) and any complications of treatment were recorded. Statistical analysis of the 76 complete sets of results using the Mann-Whitney U-test showed that there was a significant difference in the distribution of all of the treatments for each of the time intervals (p<0.05). Glass rank biserial correlation coefficients were all small (rg<0.085) but the most significant differences were between ephedrine and the control group at two hours, two, seven and 10 days (0.02, 0.054, 0.057, 0.085 respectively), alkaline nasal douches being most significant at four and 14 days (0.06 and 0.0722 respectively).

Surgical Morbidity of Neck Dissection after Chemoradiotherapy in Advanced Head and Neck Cancer

1997 ◽  
Vol 106 (2) ◽  
pp. 117-122 ◽  
Author(s):  
James P. Newman ◽  
Willard E. Fee ◽  
David J. Terris ◽  
Richard L. Goode ◽  
Harlan A. Pinto ◽  
...  
Keyword(s):  
Head And Neck ◽  
Surgical Procedures ◽  
Complication Rate ◽  
Organ Preservation ◽  
Surgical Complication ◽  
Control Group ◽  
Surgical Morbidity ◽  
Significant Difference ◽  
Duration Of Surgery ◽  
Lower Complication

The use of chemotherapy and irradiation for organ preservation attempts to eliminate the need for extensive surgery in patients with advanced squamous cell carcinoma of the head and neck (SCCHN). We sought to characterize the morbidity of surgery in patients who needed surgery after treatment with induction chemotherapy followed by simultaneous chemotherapy and radiotherapy (chemoradiotherapy). The surgical morbidity within the first 30 postoperative days of 17 patients treated in an organ preservation approach between July 1991 and December 1994 was compared with a control group of patients undergoing similar surgical procedures during the same period. The organ preservation study patients underwent surgical procedures consisting of 18 neck dissections and 5 resections of the primary site. Six patients in the organ preservation study group experienced 8 surgical complications within the first 30 postoperative days, and most complications were minor. There was no significant difference in the duration of surgery or length of hospitalization between study patients and matched controls. Our surgical complication rate (35.3%) was higher but not statistically different from that of the control group, and compared favorably to reports of surgical morbidity (44% to 61%) in the literature on patients treated with chemoradiotherapy. The lower complication rate seen in this study may be a reflection of early surgical intervention as part of our organ preservation study scheme, the preponderance of neck dissections performed, and the limited number of pharyngeal procedures performed.

Homeopathy: statistical significance versus the sample size in experiments with Toxoplasma gondii

2021 ◽  
Vol 10 (36) ◽  
pp. 115-118
Author(s):  
Érika Cristina Ferreira ◽  
Paula Fernanda Massini ◽  
Caroline Felicio Braga ◽  
Ricardo Nascimento Drozino ◽  
Neide Martins Moreira ◽  
...  
Keyword(s):  
Toxoplasma Gondii ◽  
Sample Size ◽  
Biological Effects ◽  
Statistical Significance ◽  
Rare Event ◽  
Public Health Problem ◽  
Control Group ◽  
Bootstrap Analysis ◽  
Significant Difference ◽  
The World

Introduction: Toxoplasmosis is a zoonosis that represents a serious public health problem, caused by Toxoplasma gondii, which affects 20-90% of the world human population [1,2]. It is a serious problem especially when considering the congenital transmission due to congenital sequels. Treatment with highly diluted substances is one of the alternative/complementary medicines most employed in the world [3,4]. The current ethical rules regarding the number of animals used in animal experimental protocols with the use of more conservative statistical methods [5] can not enhance the biological effects of highly diluted substances observed by the experience of the researcher. Aim: To evaluate the minimum number of animals per group to achieve a significant difference among the groups of animals treated with biotherapic T. gondii and infected with the protozoan regarding the number of cysts observed in the brain. Material and methods: A blind randomized controlled trial was performed using eleven Swiss male mice, aged 57 days, divided into two groups: BIOT-200DH - treated with biotherapic (n=6) and CONTROL - treated with hydroalcoholic solution 7% (n=7).The animals of the group BIOT-200DH were treated for 3 consecutive days in a single dose 0.1ml/dose/day. The animals of BIOT – 200DH group were orally infected with 20 cysts of ME49-T. gondii. The animals of the control group were treated with cereal alcohol 7% (n=7) for 3 consecutive days and then were infected with 20 cysts of ME49 -T. gondii orally. The biotherapic 200DH T. gondii was prepared with homogenized mouse brain, with 20 cysts of T. gondii / 100μL according to the Brazilian Homeopathic Pharmacopoeia [6] in laminar flow. After 60 days post-infection the animals were killed in a chamber saturated with halothane, the brains were homogenized and resuspended in 1 ml of saline solution. Cysts were counted in 25 ml of this suspension, covered with a 24x24 mm coverglass, examined in its full length. This study was approved by the Ethics Committee for animal experimentation of the UEM - Protocol 036/2009. The data were compared using the tests Mann Whitney and Bootstrap [7] with the statistical software BioStat 5.0. Results and discussion: There was no significant difference when analyzed with the Mann-Whitney, even multiplying the "n" ten times (p=0.0618). The number of cysts observed in BIOT 200DH group was 4.5 ± 3.3 and 12.8 ± 9.7 in the CONTROL group. Table 1 shows the results obtained using the bootstrap analysis for each data changed from 2n until 2n+5, and their respective p-values. With the inclusion of more elements in the different groups, tested one by one, randomly, increasing gradually the samples, we observed the sample size needed to statistically confirm the results seen experimentally. Using 17 mice in group BIOT 200DH and 19 in the CONTROL group we have already observed statistical significance. This result suggests that experiments involving highly diluted substances and infection of mice with T. gondii should work with experimental groups with 17 animals at least. Despite the current and relevant ethical discussions about the number of animals used for experimental procedures the number of animals involved in each experiment must meet the characteristics of each item to be studied. In the case of experiments involving highly diluted substances, experimental animal models are still rudimentary and the biological effects observed appear to be also individualized, as described in literature for homeopathy [8]. The fact that the statistical significance was achieved by increasing the sample observed in this trial, tell us about a rare event, with a strong individual behavior, difficult to demonstrate in a result set, treated simply with a comparison of means or medians. Conclusion: Bootstrap seems to be an interesting methodology for the analysis of data obtained from experiments with highly diluted substances. Experiments involving highly diluted substances and infection of mice with T. gondii should be better work with experimental groups using 17 animals at least.

A Randomized Study to Assess the Impact of Pharmacist Counseling of Employer-Based Health Plan Beneficiaries With Diabetes

2011 ◽  
Vol 25 (2) ◽  
pp. 169-179 ◽  
Author(s):  
Dale F. Kraemer ◽  
Wayne A. Kradjan ◽  
Theresa M. Bianco ◽  
Judi A. Low
Keyword(s):  
Diabetes Management ◽  
Statistical Significance ◽  
Glycosylated Hemoglobin ◽  
Randomized Study ◽  
Intervention Group ◽  
Control Group ◽  
Counseling Intervention ◽  
Care Plans ◽  
Pharmacist Counseling ◽  
The Impact

Objective: To assess the impact of pharmacist counseling on empowering people with diabetes to better self-care. Introduction: Community-based pharmacists can play a key role in educating and empowering people in such programs. Methods: A randomized trial compared the effects of pharmacist counseling (intervention group) with printed materials (control group) in diabetic beneficiaries of several employer-based health care plans. All participants also received waiver of out-of-pocket expenses for diabetic-related medications and supplies. Clinical, humanistic, and claim outcomes were evaluated at baseline and at 1 year follow-up. Results: Sixty-seven beneficiaries participated in this study. The 0.50% decrease from baseline in glycosylated hemoglobin (A1c) was statistically significant ( P = .0008) in the intervention group and the difference between the groups approached statistical significance ( P = .076). Beneficiaries in both groups had greater claim costs for diabetic-related medications and supplies during the study year. Both groups also improved in ability to manage their diabetes with the counseling group showing a significantly better understanding of diabetes ( P = .0024). Conclusion: There was a trend toward improvement in A1c in patients counseled by pharmacist with an increased utilization of diabetes-related medications and supplies. Counseling also improved diabetes knowledge and empowered patients to better diabetes management.

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