scholarly journals Phase I trial of WEE1 inhibition with chemotherapy and radiotherapy as adjuvant treatment, and a window of opportunity trial with cisplatin in patients with head and neck cancer: theWISTERIAtrial protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e033009 ◽  
Author(s):  
Anthony Kong ◽  
James Good ◽  
Amanda Kirkham ◽  
Joshua Savage ◽  
Rhys Mant ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Dna Damage ◽  
Phase I ◽  
Head And Neck ◽  
Therapeutic Effects ◽  
Window Of Opportunity ◽  
Link Type ◽  
Group A ◽  
Group B

IntroductionPatients with head and neck squamous cell carcinoma with locally advanced disease often require multimodality treatment with surgery, radiotherapy and/or chemotherapy. Adjuvant radiotherapy with concurrent chemotherapy is offered to patients with high-risk pathological features postsurgery. While cure rates are improved, overall survival remains suboptimal and treatment has a significant negative impact on quality of life.Cell cycle checkpoint kinase inhibition is a promising method to selectively potentiate the therapeutic effects of chemoradiation. Our hypothesis is that combining chemoradiation with a WEE1 inhibitor will affect the biological response to DNA damage caused by cisplatin and radiation, thereby enhancing clinical outcomes, without increased toxicity. This trial explores the associated effect of WEE1 kinase inhibitor adavosertib (AZD1775).Methods and analysisThis phase I dose-finding, open-label, multicentre trial aims to determine the highest safe dose of AZD1775 in combination with cisplatin chemotherapy preoperatively (group A) as a window of opportunity trial, and in combination with postoperative cisplatin-based chemoradiation (group B).Modified time-to-event continual reassessment method will determine the recommended dose, recruiting up to 21 patients per group. Primary outcomes are recommended doses with predefined target dose-limiting toxicity probabilities of 25% monitored up to 42 days (group A), and 30% monitored up to 12 weeks (group B). Secondary outcomes are disease-free survival times (groups A and B). Exploratory objectives are evaluation of pharmacodynamic (PD) effects, identification and correlation of potential biomarkers with PD markers of DNA damage, determine rate of resection status and surgical complications for group A; and quality of life in group B.Ethics and disseminationResearch Ethics Committee, Edgbaston, West Midlands (REC reference 16/WM/0501) initial approval received on 18/01/2017. Results will be disseminated via peer-reviewed publication and presentation at international conferences.Trial registration numberISRCTN76291951andNCT03028766.

Quality of life assessment in patients above 60, below 50 years of age during and after curative radiotherapy in head and neck cancers

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5552-5552 ◽  
Author(s):  
A. Turaka ◽  
B. K. Mohanti ◽  
S. Chander ◽  
S. V. Deo ◽  
R. Jena ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Elderly Patients ◽  
Phase I ◽  
Head And Neck ◽  
Phase Ii ◽  
Younger Patients ◽  
Curative Radiotherapy ◽  
Group A ◽  
Group B

5552 Background: To evaluate the Quality of life in patients above 60 and below 50 years during and after curative radiotherapy in head and neck cancers. Methods: Head and Neck cancer patients who are to undergo curative radiotherapy (RT) were divided into two groups, 49 patients (Group A,above 60 years) and 40 patients (Group B,below 50). Quality of life assessment was done using EORTC QLQ C-30 version-2 at 4 phases;Pretreatment-Phase I,during RT-Phase II,1-month post RT-Phase III and 6 months post RT-Phase IV.Statistical analysis was done with mean scores using ’t’ test. Results: Physical functioning (PF)scores in both groups were highest in phase I (69.4;77.5, p < 0.035) and lowest in phase II (40; 50, p < 0.008) and the difference was statistically significant. Although PF scores declined in both groups in phase II, overall PF score remained higher in group B than in group A in all phases.Role functioning score remained low in both groups and the difference were not statistically significant at all phases. Emotional functioning score was highest in phase I (68.37; 69.15), but declined as treatment progressed, consequent to depression.The values improved over time, restored to near pretreatment values at phase IV. Cognitive functioning scores in both groups was also highest in phase I (70.07; 79.17). Social functioning of both groups declined during RT (42.52; 45)compared to pre RT values (73.47; 77.09). The mean Global Health Status score was higher in group B compared to group A at all phases, yet there was no statistical significance.The scores declined during RT (66.87 vs 35.62 & 64.79 vs 34.01), improved overtime but did not reach pre RT scores.The symptom scores were all higher for elderly patients compared with younger patients at all phases, implying elderly patients experienced more symptoms, with greater experience of symptoms during RT. Conclusions: Quality of Life of elderly patients was lower compared to younger patients at phase II in terms of physical functioning, social and emotional functioning. Global Health Status score was higher for younger patients than elderly at all phases, and declined in phase II. No significant financial relationships to disclose.

Effect of oral pilocarpine on xerostomia and quality of life in patients receiving curative radiotherapy for head and neck cancers

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6088-6088
Author(s):  
S. Goyal ◽  
D. N. Sharma ◽  
P. K. Julka ◽  
G. K. Rath
Keyword(s):  
Quality Of Life ◽  
Head And Neck ◽  
Phase Ii ◽  
Head And Neck Cancers ◽  
Functional Scores ◽  
Symptom Scores ◽  
Oral Dryness ◽  
Group A ◽  
Group B

6088 Background: Xerostomia is the most debilitating condition following irradiation (RT) in patients with head and neck cancers. The present study intended to evaluate the effect of salivary stimulants such as pilocarpine given concurrent with RT on xerostomia and quality of life in these patients. Methods: In a prospective study conducted between July 2004 and May 2006, 60 patients receiving curative (radical or postoperative) RT for squamous cell head and neck carcinoma were randomized into two groups; group A (n=30) received concurrent pilocarpine 5 mg thrice daily for 12 weeks starting on day 1 of RT while group B (n=30) did not receive pilocarpine. Xerostomia was assessed using RTOG/EORTC criteria, and Quality of life (QOL) using EORTC QLQ-C30 version 3.0 and QLQ-H&N35 questionnaires in phases I-V: preradiation, week 4 of RT, and at 1, 3 and 6 months following completion of RT. Results: Oral dryness was the commonest toxicity, its incidence in phase II being 80% in group A and 89% in group B. By phase V, 13% patients in group A and none in group B had recovered to their pretreatment status. When compared with group B, group A had a significantly lower incidence of oral dryness in phases III (p=0.001), IV (p=0.014) and V (p=0.009) and lesser speech difficulty in phase V (p=0.021). QOL evaluation showed a decline in functional scores and rise in symptom scores during radiation with subsequent improvement to pretreatment levels in phase V. Group A had a significantly higher physical functioning score than group B in phases III (p=0.037) and IV (p=0.027), a better emotional functioning score in phases III (p=0.046) and IV (p=0.008), and a higher global health score, especially in phases II (p=0.012) and III (p=0.001). QLQ-C30 symptom scores were comparable between the 2 groups while H&N35 symptom scores were higher in group B with higher painkiller use in phase II (p=0.043) and IV (p=0.011), and higher dryness (p=0.025), sticky saliva (p=0.021) and constipation (p=0.011) in phase IV. Conclusions: Concurrent pilocarpine during head and neck RT helps maintain salivary function, reduces xerostomia and improves the quality of life in these patients, both during and after RT, especially in terms of parameters related directly to xerostomia. No significant financial relationships to disclose.

scholarly journals A study to compare the effectiveness of core strengthening exercises for phase I and phase II of menstrual cycle in primary dysmenorrhea subjects

Biomedicine ◽  
2021 ◽  
Vol 41 (2) ◽  
pp. 315-317
Author(s):  
S Zainab ◽  
P. Nithyashree ◽  
R Jumanah ◽  
M Kamalakannan ◽  
Suganthirababu Prathap ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Menstrual Cycle ◽  
Phase I ◽  
Phase Ii ◽  
Primary Dysmenorrhea ◽  
Significant Difference ◽  
Strengthening Exercises ◽  
Group A ◽  
Group B

Introduction and Aim:The common gynaecological problem among females found to be Dysmenorrhea, which is a cramping pain in the lower abdomen occurring at menstruation in the absence of any identifiable pelvic disease with a prevalence rate of 60%-90%. The consequences of primary dysmenorrhea affect quality of life (QOL) and limitations in daily activities as well as absenteeism. There is no open literature on which phase of the menstrual cycle is better to exercise in and is more effective. The aim of this study was to compare the effectiveness of core strengthening exercises for Phase I and Phase II of menstrual cycle in primary dysmenorrhea subjects and find out which phase is best to exercise in.   Materials and Methods: A total of 150 subjects were selected using convenient sampling technique based on inclusion and exclusion criteria and randomly allotted into 2 groups (group A and group B)containing 75 subjects each. Group A (Phase I follicular phase)and group B (Phase II luteal phase) performed core strengthening exercise protocol for a duration of 3 menstrual cycles (12 weeks). Working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD) score as well as EQ 5-D 5-L (Euroql5 dimension 5 level quality of life questionnaire) values were obtained before and after the intervention.   Results: An unpaired t-test of the post-test mean values of phase I and II groups show that there is a significant difference between the two groups(p-value<0.0001)   Conclusion: From the results,it can be concluded that there is a significant difference in effectiveness of core strengthening exercises between phase I and phase II and thus exercising in Phase I is most effective.  

scholarly journals Impact of early dysphagia intervention on swallowing function and quality of life in head and neck cancer patients treated with intensity-modulated radiation therapy or image guided radiation therapy with or without surgery/chemotherapy

2015 ◽  
Vol 01 (01) ◽  
pp. 037-043 ◽  
Author(s):  
Rajender Kumar ◽  
Hitesh Gupta ◽  
Keshavanand Konwar ◽  
Ritesh Sharma ◽  
Anil Anand ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Radiation Therapy ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Cancer Patients ◽  
Neck Cancer ◽  
Swallowing Function ◽  
Group A ◽  
Group B

Abstract Introduction: Dysphagia is a very common problem associated with head and neck cancer patients. Inspite of best of technologies like Intensity Modulated Radiotherapy (IMRT) or Image Guided Radiotherapy (IGRT), Dysphagia remains a major problem in locally advanced head and neck cancer patients. Materials and Methods: We randomized 50 head and neck cancer patients, including all sites and stages into two groups, 25 patients in each group. In Group-A dysphagia prevention exercises were done from the day of the onset of radiation therapy and continued till 6 months, while in Group-B no dysphagia interventions were given. We analyzed rate of dysphagia, aspiration rate and its impact on quality of life. We used M.D. Anderson Dysphagia Inventory (MDADI) which is a validated and reliable questionnaire designed specifically for evaluating impact of dysphagia on quality of life (QOL) in head and neck cancer patients. American Speech language Hearing Association (ASHA) scale was used for assessing swallowing function. Penetration Aspiration Scale (PAS) was used to assess aspiration during swallowing with the help of Fiberoptic Endoscopic Evaluation of Swallowing (FEES). Results: Quality of life was significantly better in dysphagia preventive exercise arm (group - A). There was significant improvement in the MDADI score, from the baseline to 6 months in exercise arm (14 versus 7.76, p= 0.017). Swallowing function score was also in favour of exercise arm (6.44 versus 5.8, p=0.002). Patients in exercise arm were able to swallow much better by the end of 6 months post radiotherapy. Risk of silent aspiration as evaluated by PAS score at the end of three months was 36% (Group A = 16%, Group B = 20%). At the end of six months, it improved to 24% (Group A = 8%, Group B = 16%). There was a trend towards lesser incidence of aspiration in exercise arm, although it was not statistically significant (p=0.21). Conclusion: Results from this study demonstrated that swallowing exercises, if administered from first week of chemo-radiation and continued till 6 months, results in significant improvement in swallowing function and quality of life. Use of FEES helps in detection of silent aspiration at an early stage and reduces aspiration related morbidities.

scholarly journals Assessment of the quality of life and performance status in patients with oral submucous fibrosis in central India

2018 ◽  
Vol 91 (2) ◽  
pp. 203-208
Author(s):  
Revant H. Chole ◽  
Ranjitkumar Patil
Keyword(s):  
Quality Of Life ◽  
Head And Neck ◽  
Performance Status ◽  
Oral Submucous Fibrosis ◽  
European Organization ◽  
Group A ◽  
Submucous Fibrosis ◽  
And Performance ◽  
Group B

Background and aims. Measuring quality of life in patients with oral submucous fibrosis is of utmost importance in assessing treatment outcomes. This study examined the impact of oral submucous fibrosis and its treatment on the quality of life and performance status of persons with oral submucous fibrosis.Methods. Quality of life was measured in patients with oral submucous fibrosis using the European Organization for Research and Treatment of Cancer Quality of Life head and neck 35 Questionnaire (EORTC QLQ-C35); performance status was measured by Performance Status Scale for Head and Neck Cancer Patients (PSS-HN), at four points in time: baseline, one month, two months and three months after start of treatment.Results. At the end of third month Group A and Group B showed 78% and 85% increase in mouth opening respectively. While the burning sensation of oral mucosa was decreased by 72% and 88% in group A and group B respectively (Z>1.96, P<0.05), there were significant differences in patients' quality of life and functioning at three points in time (P < 0.05).Conclusion. The European Organization for Research and Treatment of Cancer Quality of Life head and neck 35 Questionnaire and Performance Status Scale for Head and Neck Cancer Patients can be used successfully in potentially malignant disorders like oral submucous fibrosis. The results in this study will surely be a good guide forother studies on oral submucous fibrosis.

Joint involvement influences quality of life in systemic lupus erythematosus patients

Lupus ◽  
2020 ◽  
pp. 096120332097903
Author(s):  
Francesco Natalucci ◽  
Fulvia Ceccarelli ◽  
Enrica Cipriano ◽  
Carlo Perricone ◽  
Giulio Olivieri ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lupus Erythematosus ◽  
Disease Duration ◽  
Joint Involvement ◽  
Systemic Lupus ◽  
Median Disease Duration ◽  
Group A ◽  
Musculoskeletal Manifestations ◽  
Group B

Introduction Joint involvement represents the major determinant in quality of life (QoL)in Systemic Lupus Erhytematosus (SLE) patients. However, QoLhas been generally evaluated by non-specific questionnaires. We evaluated the relationship between SLE musculoskeletal manifestations and QoL, assessed by LupusQoL. Methods Patients with joint involvement (group A) were compared with those without this feature (group B). Disease activity was assessed by SLEDAI-2k in the whole population, while DAS28 and swollen to tender ratio were applied to assess joint activity. LupusQoL was administered to all the patients. Results Group A included 110 patients [M/F 8/102; median age 49 years (IQR 13), median disease duration 156 months (IQR 216)], group B 58 [M/F 11/47; median age 40 years (IQR 15), median disease duration 84 months (IQR 108)].We found significanlty lower values in all the LupusQoL domains except for one (burden to others) in group A in comparison with group B. A significant correlation between DAS28 values and all the LupusQoL domains in group A was found; only three domains correlated with SLEDAI-2k. Conclusions SLE-related joint involvement significantly influences disease-specific QoL. DAS28 better correlated with LupusQoL domains in comparison with SLEDAI-2k, confirming the need for specific musculoskeletal activity indices.

Comparison of Post-Operative Quality of Life between Vaginal Hysterectomy and Abdominal Hysterectomy

2021 ◽  
Vol 15 (7) ◽  
pp. 1801-1803
Author(s):  
Nazia Sajjad ◽  
Sara Qadir ◽  
Rukhsana Kasi ◽  
Tayyaba Rasheed ◽  
Fozia Unar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Vaginal Hysterectomy ◽  
Controlled Trial ◽  
Abdominal Hysterectomy ◽  
Study Group ◽  
Randomized Controlled ◽  
Group A ◽  
Group B ◽  
Satisfactory Quality

Objectives: To compare the frequency of satisfactory quality of life between vaginal hysterectomy and abdominal hysterectomy. Study Design: Randomized controlled trial. Place and Duration of Study: Department of Obstetrics and Gynecology, Niazi Medical & Dental College, Sargodha from 1st April 2020 to 31st December 2020. Methodology: Ninety patients were comprised and they were divided in two groups; group A (vaginal hysterectomy) and Group B (abdominal hysterectomy) were performed. Hysterectomies (vaginal or abdominal) were performed by consultant gynecologist having experience at having least 5 years). Results: Mean age of the patients was 49.82±3.207 years, mean age of the patients of group A was 49.82±3.193 years and mean age of the patients of group B was 49.82±3.256 years. Satisfactory quality of life was noted in 38 (84.44%) patients of study group A and 29 (64.44%) patients of study group B. Statistically significant (P = 0.051) difference between the frequency of satisfactory quality of life between the both groups was noted. Conclusion: Results of this study reveals that post hysterectomy quality of life found more satisfactory in vaginal hysterectomy group as compared to abdominal hysterectomy group. Insignificant association of post hysterectomy quality of life with age group, marital status, parity and socio-economical status was found. Findings of this study also revealed that post hysterectomy satisfactory quality of life is not associated with education of the patients. Key words: Hysterectomy, Quality of life, abdomen, vagina, WHO, Uterus

scholarly journals Immediate Effect of Muscle Energy Technique and Kalternborn Mobilisation Technique on Pain in Diabetic Patients with Periarthritis of Shoulder

2021 ◽  
pp. 220-228
Author(s):  
Kamya Somaiya ◽  
G. D. Vishnu Vardhan ◽  
Ashish Bele
Keyword(s):  
Quality Of Life ◽  
Adhesive Capsulitis ◽  
Frozen Shoulder ◽  
Diabetic Patients ◽  
Tissue Degeneration ◽  
Muscle Energy Technique ◽  
Group A ◽  
Muscle Energy ◽  
Group B

Background: Periarthritis Shoulder, also known as adhesive capsulitis, is a condition that results in tissue degeneration, thickening of the joint capsule, and a narrowing of the glenoid cavity. Diabetes mellitus is linked to many debilitating musculoskeletal disorders of the hand and shoulder. Prevalence of adhesive capsulitis or frozen shoulder is estimated to be 11-30 percent in people with diabetes. Various interventions have already been used to prevent pain and improve quality of life. Both Muscle Energy Technique and Kalternborn Mobilization Technique are thought to have a pain-relieving effect. Aim & Objective: The study's aim is to compare the effects of both techniques on pain in diabetic patients. Methods/Design: In this study experimental study, the participants will be divided into two groups: Kalternborn Mobilization Technique Group (A) and Muscle Energy Technique Group (B) based on inclusion and exclusion criteria. Both interventions include 30-45 min session which will be carried out for duration of four days. Outcome will be Pain and Quality of Life and outcome measures will be evaluated at beginning and at the end of intervention period. Result: Successful Completion of trial of Muscle Energy Technique and Kalternborn Mobilisation Technique will provide evidence for best strategy targeting Pain and quality of life in diabetic patients with Periarthritis of Shoulder. Conclusion: The study will be concluded with the significant effect of Muscle Energy Technique and Kalternborn Mobilisation Technique on Periarthritis shoulder of diabetic patients.

scholarly journals BIOBRAN MGN-3

2012 ◽  
Vol 20 (01) ◽  
pp. 13-16
Author(s):  
Ahmad Ijaz Masood ◽  
RABEETA SHEIKH ◽  
RANA ATIQUE ANWER
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Hair Loss ◽  
White Blood Cells ◽  
Food Supplement ◽  
Severe Nausea ◽  
Treatment Side Effects ◽  
Group A ◽  
Group B

Objective: The aim of study was to assess the effect of Biobran in reducing of chemotherapy induced side effects in termsof tiredness, anorexia, vomiting and hair loss and quality of life in terms of weight loss. Setting: Radiotherapy Department, NishtarHospital Multan. Material and Methods: Fifty patients of breast cancer were enrolled randomly in two groups. Group-A patients weregiven 3 gram dose of Biobran MGN-3 per day one week before and one week after chemotherapy. Group-B patient were givenchemotherapy alone. Total six cycles of chemotherapy were given. No multivitamin or food supplements were given during this study.Chemotherapy induced side effects (tiredness, anorexia, and vomiting, hair loss) were assessed by questionnaire to the patients beforestart of each cycle. Weight was checked before each cycle to assess weight gain or loss. White blood cells were checked by completeblood count just before and one week after chemotherapy. Results: Between six months, 50 patients were enrolled in RadiotherapyDepartment, Nishtar Hospital Multan. There was a significant reduction in tiredness and anorexia in group-A patients. 20 (80%) patients ofgroup-A felt increase in their diet and no tiredness without any appetizer or multivitamin. But group-B patients demanded for appetizer dueto severe anorexia after chemotherapy except 3 (12%) patients who didn’t use any appetizer or food supplement. In group-A, 15 (60%)patients didn’t need any anti-emetic as compared to group-B all patient (100%) experienced severe nausea during and afterchemotherapy. Group-A patients experienced less hair fall 7 (28%) patients as compared to other group which is 25 (100%) patients.Conclusions: The study showed that, by helping to optimize the immune system, Biobran MGN-3 can not only help maximize treatmentsuccess, but also minimize treatment side effects and improve quality of life during treatment and in recovery.

scholarly journals Effects of Nonsurgical Spinal Decompression Treatment on the Level of Pain and Quality of Life in Patients with Cervical or Lumbar Disc Herniation: A Retrospective Observational Study

2020 ◽  
Vol 37 (4) ◽  
pp. 259-269
Author(s):  
Beom Seok Kim ◽  
Ye Ji Lee ◽  
Hyo Bin Kim ◽  
Ki Jung Sung ◽  
Ju Hyun Jeon ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Observational Study ◽  
Analysis Of Covariance ◽  
Retrospective Observational Study ◽  
Spinal Decompression ◽  
Traditional Korean Medicine ◽  
Korean Medicine ◽  
Group A ◽  
Group B

Background: This study aims to statistically analyze and compare the curative effect and satisfaction level between typical traditional Korean medicine treatment and nonsurgical spinal decompression treatment.Methods: Of the patients who were diagnosed with the cervical or lumbar herniated intervertebral disc at the Department of Acupuncture and Moxibustion Medicine at the Daejeon Korean Medicine Hospital from April 14<sup>th</sup> to August 25<sup>th</sup>, 2019, this study retrospectively analyzed the medical records of 31 patients who underwent nonsurgical spinal decompression treatment and traditional Korean medicine (assigned to Group A) and another 31 patients who received typical traditional Korean medicine alone (assigned to Group B). The clinical data were analyzed using IBM SPSS Version 23.0.Results: No statistically significant differences appeared in terms of sociodemographic, condition, and therapeutic characteristics, except whether the patient received Western medicine treatment, before or after a treatment with traditional Korean medicine. Group A exhibited higher variations in numeric rating scale, EuroQol- 5 dimension and EuroQol visual analogue scale scores compared to Group B as determined by independent sample <i>t</i> test and analysis of covariance. In addition, the satisfaction score of Group A was higher than that of Group B The result of cross analysis revealed that desire for continued treatment in Group A was higher than that of Group B.Conclusion: This retrospective observational study showed that the patients with nonsurgical spinal decompression treatment reported a greater reduction in pain, improved quality of life and satisfaction than patients receiving typical traditional Korean medicine.

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