Miami NICE trial: Nutritional support for patients incurring chemotherapy side effects.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6568-6568
Author(s):  
Damien Mikael Hansra ◽  
Catherine Diaz ◽  
Skip Camp ◽  
Caroline Randolph ◽  
Christine Norman-Tiner ◽  
...  

6568 Background: Few studies have been performed addressing nutritional interventions & mitigation strategies to address side effects such as weight gain, anorexia, dysgeusia, in patients (pts) undergoing chemotherapy. We aim to study the effect of nutritional counseling on body mass index (BMI) and other side effects in pts undergoing systemic chemotherapy. Methods: Prospective randomized study of 50 pts into two groups (A & B). Group A was randomized to standard of care: oncologist visits once per month x 3 months, routine physician counseling & dietary recommendations. Group B: standard of care + nutritionist intervention which included 3 visits x 30 mins each. Nutritionists performed an initial assessment of pts at the first session (template provided in poster) then tailored dietary counseling monthly x3 months which includes dietary strategies to mitigate side effects, pt & caregiver education, recipes, & handouts (provided in poster). Inclusions: medically insured male & female adults with active malignancies (hematologic &boncologic) on chemotherapy (neoajuvant, adjuvant, palliative). Exclusions: pts with head & neck, stomach, esophagus, pancreatic tumors & pts with pre-existing cachexia. Data collected: pt gender, age, race, ethnicity, cancer subtype, TNM staging, chemotherapy regimen. Primary objective: compare change in BMI at visit 1, 2, &3. Secondary endpoints: anorexia, nausea, vomiting, depression, etc. reported in poster. Mean change in BMI, secondary endpoints compared using students T-test with ANOVA using SAS software version 8.0 & minitab version 17. Results: Group A initial BMI = 28.85 vs group B initial BMI = 27.34 (p = 0.05). Change in BMI group A vs B at visit 1 (0.4 vs 0.09, p = 0.002), visit 2 (4.6 vs -0.52, p = 0.001), visit 3 (6.5 vs 0.46, p = 0.003). Demographics & secondary endpoints reported in poster. Conclusions: We found dietary counseling in addition to standard of care was associated with significant mitigation of weight gain in patients on systemic chemotherapy. Dietary counseling is a relatively simple, inexpensive, individualized, & reproducible method to mitigate chemotherapy related weight gain.

2018 ◽  
Vol 49 (1) ◽  
pp. 44
Author(s):  
K. TSELKAS (Κ. ΤΣΕΛΚΑΣ) ◽  
P. YPSILANTIS (Π. ΥΨΗΛΑΝΤΗΣ) ◽  
Ph. SARATSIS (Φ. ΣΑΡΑΤΣΗΣ)

In this study the efficacy and safety of the administration of the progestagen proligestone for the control of the ovarian cycle of 66 female dogs were evaluated. Two to six injections of proligestone were made to those animals in anoestrus (group A, n=52) or 1 injection to those in the first 3 days of proestrus (group B, n = 14) in order to prevent or postpone oestrus, respectively. The efficacy of proligestone administration, based on the percentage of successful injections, was 98.07%, 98.03%, 98.00%, 97.67% and 88.00% after the 1st, 2nd, 3rd, 4th and 5th injection, respectively, and 96,83% in total, for group A, while 92.86% for group B. The observed side effects were: hair discoloration at the injection site, weight gain, pyometra and diabetes mellitus at α rate of 11.54%, 7.69%, 1.92% and 1.92%, respectively, for group A and 14.28%,14.28%, 7.14% and 0%, respectively, for group B.


2021 ◽  
Author(s):  
Karamat Hussain Shah Bukhari ◽  
Asma Asghar ◽  
Najma Perveen ◽  
Arshad Hayat ◽  
Sermad Ahmad Mangat ◽  
...  

AbstractObjectiveTo evaluate the efficacy of ivermectin (IVM) as an addition to the standard of care (SOC) treatment in COVID-19 patients with mild and moderate diseaseMaterials and MethodsA randomized clinical trial (Trial registration # NCT04392713) was carried out at Combined Military Hospital Lahore from March 15, 2020, to June 15, 2020. Eighty-six patients with reverse transcriptase-polymerase chain reaction (RT-PCR) proven SARS-CoV-2 infection completed the trial protocol. Patients were stratified via the lottery method into two groups. Group A was administered standard of care (SOC) treatment as per existing hospital guidelines whereas group B was given ivermectin (single dose of 12 milligrams) along with SOC treatment. PCR was repeated at 72 hours, 7th day, and at 14th day of admission for both the groups and the point at which the PCR became negative was noted. Complete blood counts, liver function tests and renal function tests were done at recruitment, 7th day, and 14th day. The primary outcome was the viral clearance, measured as days to achieve PCR negativity. The secondary outcome was the development of any adverse side effects pertinent to ivermectin or derangement in baseline laboratory parameters.ResultsIn group A, 36 (80%) participants were males, and 9 (20%) were females, whereas in group B, 37 (90.2%) were males and 4 (9.8%) were females. Mean age was 39.0± 12.6 and 42.2 ± 12.0 years for groups A and B, respectively (p= 0.394). There was early viral clearance in group B as compared to group A (p=0.001). No adverse reaction or derangements in laboratory parameters was noted in the intervention arm during the trial period.ConclusionIn the intervention arm, early viral clearance was observed and no side effects were documented. Therefore ivermectin is a potential addition to the standard care of treatment in COVID-19 patients.


2020 ◽  
pp. 1-4
Author(s):  
George-Sebastian Iacob ◽  
Constantin Munteanu

Cervical back pain is one of the most important and common musculoskeletal disorders in medical recovery clinics and clinics. The main objective of the study was to highlight the effectiveness of an individualized therapeutic program adapted to the particularities of 22 subjects, which combines physical exercise with manual therapy. Subjects were randomly assigned to two equal groups. Group A - rehabilitation protocol consisting of therapeutic exercises (specific to the head, neck and upper limbs). Group B - rehabilitation protocol that included both therapeutic exercises and manual therapy (specific maneuvers of vertebral mobilization, massage, myofascial techniques, stretching and manipulations). The Visual Analogue Pain Scale (VAS) and the Neck Disability Index (NDI) were used to monitor the evolution of the research subjects, both of which have a specific applicability character to chronic pain. According to VAS (p <0.001), Group B showed mean values reduced to 2.2 ± 0.9 at week 12, compared to 7.3 ± 0.92, following the initial assessment. NDI values indicate better functional status after 12 weeks of treatment for both groups of subjects. NDI showed a beneficial decrease for Group B (13.2 ± 2.2 after 12 weeks, compared to 25.8 ± 2.3 in the first week). The mean results of VAS and NDI indicated a better evolution of symptoms in the case of the protocol that combined exercise and manual therapy (group B), but there were no statistically significant differences (compared to group A).


Author(s):  
Parminderpal Singh ◽  
Kiranjit Kiranjit

Objective: The present study was aimed to analyze the side effects of olmesartan medoxomil and enalapril in hypertensive subjects.Methods: The study consisted of newly diagnosed hypertension categorized according to 7th report of Joint National Commission on prevention, detection, evaluation, and treatment of high blood pressure. The subjects were divided into two groups. The Group A subjects received olmesartan, and Group B subjects received enalapril. Pressure was recorded both in supine and sitting positions. The appearance of side effects was observed in the follow-up, i.e., dry cough, headache, postural hypotension, angioedema, dizziness, skin rashes, taste alterations, and urticaria. A statistical data were prepared on the basis of information obtained and analyzed thoroughly for antihypertensive effects and side effects of olmesartan and enalapril. SPSS software was used for analysis.Results: There was observed an increase in the incidence of taste alteration with drug therapy in Group B (Enalapril). There was observed an increase in the incidence of postural hypotension with drug therapy in both groups. In Group A (Olmesartan), the incidence of postural hypotension at the beginning of trial, 4 weeks, and 8 weeks was 0%, 2%, and 2%, respectively. In Group A (Olmesartan), there was no incidence of a headache at the beginning of trial, at 4 weeks and 8 weeks.Conclusion: From the study, it can be concluded that both olmesartan and enalapril are effective in Stage I and Stage II hypertension, but olmesartan is tolerated well with lesser side effects.


2020 ◽  
Vol 17 (1) ◽  
pp. 61-68
Author(s):  
Dominique Clare Oh ◽  
Yiong Huak Chan ◽  
Sao Bing Lee ◽  
Jovina Li Shuen See

Introduction: Collagen cross-linking is a useful adjunct in preventing corneal ectasia after laser-assisted in situ keratomileusis (LASIK). This study aimed to evaluate whether prophylactic cross-linking in IntraLase LASIK affects optimum visual outcome and recovery time in the immediate post-surgery period and is associated with any side effects. Methods: This was a retrospective case study on the right eyes of 100 Chinese subjects aged 18 to 40 years who underwent IntraLase LASIK. Fifty subjects who underwentcross-linking after completing LASIK (Group A) were compared with 50 subjects who did not undergo LASIK (Group B). Cases were evaluated for pre- and post-operative spherical equivalent, uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA), recovery time and presence of side effects. Results: At 1 week post-LASIK, mean (SD) UDVA of Group A subjects was poorer than Group B, at 1.05 (0.19) vs 1.17 (0.19) (p = 0.036); however, there was no significant difference in CDVA (p = 0.095). By 1 month post-LASIK, differences in both UDVA and CDVA were insignificant (p = 0.055, 0.106, respectively). Mean recovery time was 2.72 (95% confidence interval [CI] = 0.64-4.7) days longer in Group A (p = 0.010), although by 1 month post-LASIK, both groups were able to achieve CDVA equal to or better than that achieved pre-LASIK. Incidence of mild inflammation and dry eyes post-LASIK was similar in both groups (p = 1.00, 0.749, respectively); no other complications were observed. Conclusion: No differences in visual outcomes at and occurrence of side effects at 1 month post-LASIK were observed between subjects who underwent cross-linking prior to refractive surgery and those who did not. However, the group that underwent cross-linking had a slightly longer mean recovery time. Our study supports prophylactic cross-linking as a safe procedure that does not affect immediate visual outcomes among the Chinese population when used in adjunct with LASIK surgery.


2012 ◽  
Vol 20 (01) ◽  
pp. 13-16
Author(s):  
Ahmad Ijaz Masood ◽  
RABEETA SHEIKH ◽  
RANA ATIQUE ANWER

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.


2021 ◽  
Vol 9 (1) ◽  
pp. 74-78
Author(s):  
Neena Jain ◽  
Rahul Bankapur ◽  
Preeti Lamba ◽  
saurav Singh

Background and Aims: Gabapentin and pregabalin, by decreasing noxious stimulus induced excitatory neurotransmitter release at central nervous system, may attenuate central sensitization and eventually decrease development of postoperative pain. We evaluated preemptive analgesic efficacy of single dose of oral gabapentin 600 mg and pregabalin 75mg for postoperative pain in patients undergoing lower limb orthopedic surgery under spinal anesthesia. Material and methods: A prospective, randomized, double blind study was conducted on 70 patients aged between 18 to 60 years with ASA grade 1 and 2 posted for lower limb surgeries under spinal anaesthesia. Patients were allocated into Group A and Group B receiving oral gabapentin(600mg) and oral pregabalin (75mg) respectively 1.5 hours before surgery. Primary objective was assessing duration and quality of analgesia by Visual Analogue Scale (VAS) score at 2,4,6,8,10,12,16,20 and 24 hours.Secondary objective was to assess total dose of rescue analgesic in first 24 hours, perioperative hemodynamic change and various side effects. Statistical Analysis used: Categorical data was compared using Chi- square test. Quantitative parametric data was analysed using unpaired student t-test. P value < 0.05 was considered statistically significant. Results: Mean duration of analgesia in Group A (10.53 ± 2.686 hours) was longer than Group B (7.943±3.199hr) (P = 0.0006).Mean number of analgesic dosesrequired in first 24 hourswere less in Group A (1.429 ± 0.5021) ascompared to Group B (1.771±0.6897) (P = 0.0202).All patients remained hemodynamically stable with no significant side effects noted in either group. Conclusion: We conclude that preemptive analgesic efficacy of oral gabapentin 600mg is better in comparison to oral pregabalin 75 mg for patients posted for lower limb orthopedic surgeries under spinal anesthesia.


2020 ◽  
pp. 1-3
Author(s):  
Spiliotis J ◽  
◽  
Farmakis D ◽  
Raptis A ◽  
Kopanakis N ◽  
...  

Cytroreductive surgery (CRS) and HIPEC are controversial effective treatment options for selected patients with peritoneal metastases. We retrospectively examined 4.500 patients with peritoneal metastases from different tumors from 2005 to 2020. Patients were divided in 4 groups, surgery plus HIPEC and then systemic chemotherapy: Group A n=730, Group B n=700, R0 surgery plus systemic chemotherapy, Group C n=870, palliative surgery plus systemic chemotherapy and Group D n=2.200, palliative care and best support. The postoperative outcomes, morbidity, mortality were compared between the 4 groups. The mean survival rates Group A=24,4+10,2m, Group B= 18,4+6,3m, Group C=12,3+5,7m, Group D=5,8+2,3m (p<0.05 between Gr A vr Gr B). There was no statistically significant difference in the 30-day mortality and morbidity. In conclusion CRS + HIPEC are feasible in 16% of our patients with peritoneal metastases and are associated with pro-longed survival.


2021 ◽  
pp. 021849232110676
Author(s):  
Zied Chaari ◽  
Abdessalem Hentati ◽  
Aimen Ben Ayed ◽  
Walid Abid ◽  
Imed Frikha

Background Pulmonary surgery is often associated with postoperative prolonged parenchymal air-leak. The purpose of this study was to determine efficacy and safety of povidone iodine as treatment of prolonged parenchymal air-leak following all-types of lung surgery. Methods This prospective trial was conducted from June 2019 to December 2020, and designed under PanAfrican Clinical Trials Registry requirements. Patients having prolonged parenchymal air-leak were randomly allocated to povidone iodine protocol (Group A) or surveillance without povidone iodine (Group B). We collected the number of povidone iodine injections required before bubbling stopped, total drainage period, tolerance after injection, complications and side-effects. Comparative study was performed to evaluate povidone iodine efficacy. Results Following randomization, Group A included 19 patients, and Group B 21. Both groups were comparable. The mean drainage period was 9.21 days in Group A (6–14 days) and 15.62 days in Group B (7–31 days) ( p = 0.001). The mean hospitalization period was 11.05 days in Group A (7–16 days) and 18.9 days in Group B (9–38 days) ( p < 0.0001). The mean follow-up period was 6.8 months (3–18 months). No deaths were noted in either groups. Four side-effects were reported in Group A (21%) and four serious complications were noticed in Group B (19%). No recurrences were reported in Group A versus one recurrence of homolateral pneumothorax in Group B (4.76%). Conclusions Povidone iodine is an effective and safe solution for pleurodesis. It is associated with a low complication rate that remains acceptable, and could be proposed as treatment of prolonged parenchymal air-leak after lung resections.


2019 ◽  
Vol 21 (2) ◽  
pp. 92-96
Author(s):  
Sharmin Reza ◽  
Sadia Sultana ◽  
Fatima Begum ◽  
Rahima Perveen ◽  
Zeenat Jabin ◽  
...  

Objective: It is well established that citrus stimulation has a definite role in preventing salivary gland damage after radioiodine therapy. The aim of this study was to observe how effectively this stimulation can be used to prevent salivary gland damage and whether the timing of sucking citrus substances play any role in preventing this damage more effectively. Patients and Methods: A total of 128 differentiated thyroid cancer (DTC) patients who received radioiodine treatment for thyroid carcinoma were divided into two groups- group-A and group-B. Group-A patients started citrus stimulation 1 hour after radioiodine ingestion and group-B patients started 24 hours after RAIT. Patients were followed-up at 5th day, 3rd month, and 6th month after RAIT. Follow up procedure consisted of physical examination and history of pain and swelling in salivary gland regions, taste dysfunction and dryness of mouth. Result: The incidence of different types of salivary glands side effects and abnormal scan findings were significantly high in the group of patients who were advised to start citrus stimulation 1 h after radioiodine ingestion. On the other hand, patients who started citrus stimulation 24 h after RAIT suffered less from salivary gland side effects.  Conclusion: This study showed that delayed initiation of citrus stimulation was more effective in reducing salivary gland damage after RAIT. Bangladesh J. Nuclear Med. 21(2): 92-96, July 2018


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