scholarly journals Anxiety during Radiation Therapy: A Prospective Randomized Controlled Trial Evaluating a Specific One-on-One Procedure Announcement Provided by a Radiation Therapist

Cancers ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 2572
Author(s):  
Delphine Antoni ◽  
Céline Vigneron ◽  
Jean-Baptiste Clavier ◽  
Sébastien Guihard ◽  
Michel Velten ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ct Scan ◽  
State Anxiety ◽  
Radiation Treatment ◽  
Controlled Trial ◽  
Alternative Therapy ◽  
Mean Value ◽  
Radiation Therapist ◽  
Significant Difference

Background: Anxiety impacts patient outcomes and quality of life in response to cancer diagnosis. A prospective phase 3 trial randomizing 126 patients was conducted to determine whether a specific one-on-one procedure announcement provided by a radiation therapist before CT scan simulation decreases anxiety for patients with breast cancer requiring radiotherapy. Material and Methods: Anxiety was measured using the STAI form, and the QLQ-C30 and BR-23 questionnaires were used to evaluate quality of life. Results: Mean trait or state anxiety scores before CT scan simulation, before the first and second sessions, and at the end of radiation treatment were not significantly different. We observed a decrease in the level of anxiety with time; however, no significant difference in mean state anxiety scores at any of the time intervals was detected. Factors, such as anxiety trait score, professional and marital status, age, and use of alternative therapy, did not significantly influence the evolution of anxiety status over time or the mean value. Anxiety was significantly influenced by the level of fatigue. Patients who benefited from the radiation therapists’ advice felt significantly better informed. Conclusions: The one-on-one program announcement occurring before CT scan simulation led to patients being more informed and greater satisfaction but did not decrease anxiety.

scholarly journals Quality of life of obstetrics fistula patients before and after surgical repair in the Jimma University Medical Center, Southwest Ethiopia

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Tilahun Fufa Debela ◽  
Zerihun Asefa Hordofa ◽  
Aster Berhe Aregawi ◽  
Demisew Amenu Sori
Keyword(s):  
Quality Of Life ◽  
Surgical Repair ◽  
Obstetric Fistula ◽  
Medical Center ◽  
Mean Value ◽  
Significant Difference ◽  
Before And After ◽  
The Mean ◽  
Jimma University

Abstract Background The consequences of obstetric fistula on affected women are more than the medical condition. It has extensive physical, psychological, social, and economic consequences on them. Obstetric fistula affects the entire health and entire life of women. Women suffering from obstetric fistula are often abandoned by her partner, relatives, and the community. This study aimed to determine the quality of life of obstetrics fistula patients before and after surgical repair. Methods Institutional-based prospective, before and after study design was conducted in the Jimma University Medical Center from November 1, 2019–October 30, 2020. A face-to-face interview was conducted with fistula patients who visited Jimma University Medical center, fistula clinic during the study period. All fistula patients were included in the study. Accordingly, 78 women who underwent surgical repair were interviewed. The means and the standard deviation were computed using conventional statistics formulas. The unpaired t-test was used to compare two independent means, and one-way analysis of variance (ANOVA) was used to compare the quality of life before repair and after a successful repair. Linear regression analysis was done for identifying determinants of quality of life. A P value of 0.05 will be considered statistical significance. Result The overall quality of life of women was 58.17 ± 7.2 before the surgical repair and 71.20 ± 10.79 after surgical repair. The result indicates there is a significant difference in the mean value of pre and post-operative (P < 0.001). The overall satisfaction of women with their health status before the surgical repair was 22.5 ± 1.30and it has increased to 53.0 ± .90after surgical repair. The physical health dimension score was 16.51 ± 5.27 before the surgical repair while it has increased to 21.77 ± 5.38 after the surgical repair. The score of the social domain before the surgical repair was 5.19 ± 1.34 and it has increased to 7.13 ± 3.67 after the surgical repair. The score of the environmental health domain was 17.41 ± 2.89 before the surgery while it also increased to 21.65 ± 4.04 after the surgical repair. The results have shown there was a significant difference in the mean values of pre and post-operatives in both social and environmental scores (P < 0.001). The score of the psychological health domain before the surgery was 19.06 ± 1.46 and it was increased to 19.84 ± 3.21 after the surgical repair. The result showed there is a significant difference in mean value pre and post-operative (P = 0.048), though it is a slight improvement compared to other domains. Conclusion The overall quality of life of the patient with fistula was improved after successful surgical repair. Although all domains of quality of life had shown significant improvement after successful surgical repair, the psychological domain showed slight improvement.

Yoga in women undergoing treatment for breast cancer: Impact on quality of life in a randomized controlled trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 527-527
Author(s):  
Nita S. Nair ◽  
Nishu Singh Goel ◽  
Rohini W Hawaldar ◽  
Shabina Siddique ◽  
Vani Parmar ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Adjuvant Therapy ◽  
Low Cost ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Disease Free Survival ◽  
Complementary Therapy ◽  
Significant Difference

527 Background: Yoga has been tested in multiple small-randomized studies for its impact on quality of life (QOL) on breast cancer (BC). We propose to study the effect of yoga on disease free survival as the primary endpoint in women with operable breast cancer. (Study methodology details refer to NCT02161900). Methods: Women with non-metastatic BC were randomized to yoga and conventional exercise (YCE) versus conventional exercise only (CE) in addition to standard therapy. Over and above documentation of recurrence and death, QOL was assessed in these women using the EORTC QLQC30, BR23, Brief fatigue inventory (BFI), Visual pain scores (VPS) and a spirituality questionnaire (SQ). EORTC QLQ was assessed at baseline (BL), 6-9 months (mo), 18-21 mo. BFI and VPS at BL, 6-8 mo and 12-15 mo and SQ at BL and 12-15 mo. We report the first interim analysis of QOL in 605 patients randomized to the study with atleast 1 year of follow up. The groups were balanced in both arms with respect to clinico-pathological factors. Results: At 6-9 mo (completion of adjuvant therapy), there was no significant difference in global QOL scores (p = 0.08), however 52% women on YCE showed an improvement from baseline compared to 42% in CE. At 18-21 mo emotional function scores were better in YCE (p = 0.002); with lesser systemic side effects in YCE arm (44% vs 56% p = NS). The median score of fatigue after adjuvant therapy measured by QLQ C30 was lower in YCE (17.37vs22.22, p = 0.003) which was similar to that observed by BFI at 12-15 mo (1.6vs 2, p = 0.04). Also in YCE there was lower reporting of detriment in general activity (41%vs 59%) and mood (34%vs66%) (p = NS). In VPS at 12-15mo, the median scores for pain intensity (p = 0.042), pain on movement (p = 0.038), pain on mobilization (p = 0.008) were lower in YCE. Lastly SQ assessed spirituality and showed no difference, but less deterioration compared to baseline scores in YCE. Conclusions: Yoga did not show a significant difference in global QOL but had a major benefit reaching statistical significance in fatigue, emotional score and pain. Yoga is a low-risk, low-cost complementary therapy that may improve compliance to therapy by improving parameters that can affect day-to-day activity in women with breast cancer. Clinical trial information: NCT02161900.

Biopsy versus resection in the management of malignant gliomas: a systematic review and meta-analysis

2010 ◽  
Vol 112 (5) ◽  
pp. 1020-1032 ◽  
Author(s):  
Abraham Tsitlakidis ◽  
Nicolas Foroglou ◽  
Christos A. Venetis ◽  
Ioannis Patsalas ◽  
Athanasios Hatzisotiriou ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Overall Survival ◽  
Malignant Glioma ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Malignant Gliomas ◽  
Karnofsky Performance Scale ◽  
Significant Difference

Object The aim of this study was to answer the question whether quality of life and progression-free and overall survival are increased in adults with supratentorial malignant glioma who are treated with cytoreductive resection as compared with those who only undergo biopsy. Methods A literature search of the electronic databases MEDLINE, EMBASE, and CENTRAL was performed to identify relevant studies published before May 2008. Hand-searching of reference lists of the identified studies and relevant review articles was also performed. A study was considered eligible, regardless of study design (prospective or retrospective), if: 1) quality of life and/or progression-free and/or overall survival was compared among adult patients undergoing biopsy or resection, and 2) patient age and Karnofsky Performance Scale scores were not significantly different among the 2 groups compared. Results One randomized controlled trial and 4 retrospective studies (involving a total of 1111 patients) were found eligible for this systematic review. A meta-analysis of the eligible studies demonstrated a significant increase in overall survival in the patients treated with resection instead of biopsy (hazard ratio 0.61, 95% CI 0.52–0.71, p < 0.0001, fixed-effect model). Although statistical pooling was not feasible, the available data suggest that quality of life was increased in patients treated with resection rather than biopsy, while there did not seem to be any significant difference in progression-free survival between the 2 groups. Conclusions Based on the best available evidence, it appears that cytoreductive resection in adults with supratentorial malignant glioma is associated with improved overall survival as compared with biopsy. However, well-designed prospective studies are needed for more solid conclusions to be drawn.

scholarly journals Modulation of the human immune status by spinal thermal massage: a non-randomized controlled study

2021 ◽  
Keyword(s):  
Quality Of Life ◽  
Nk Cells ◽  
Nk Cell ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Experimental Group

Thermal and massage therapies have long been used to control pain. Although spinal thermal massage (STM) has been used worldwide, its effectiveness has not been proven in a controlled clinical study. We here conducted a non-randomized controlled trial to assess the pain-relieving and immunomodulatory effects of STM in old-aged patients experiencing pain or disability. The experimental group was treated with STM five times a week for 8 weeks and rehabilitative regular care (RRC). The control group was treated with only RRC. Pain and immunological parameters were tested before treatment and after 4 and 8 weeks of treatment. The scores of three pain parameters were lowered by STM, and the differences between the groups were statistically significant at the two time points (p < 0.01). Quality of life determined using the 3-level EuroQol five-dimensional questionnaire scores was significantly higher in patients in the experimental group than those in the control group. Effect sizes (ES) were in the range of medium to large in the pain-related measures (0.54–1.22). The total leukocyte counts and the proportions of lymphocytes and subsets were not significantly different between the groups, whereas the proportions of monocytes and natural killer (NK) cells were higher in the experimental group than in the control group after 8 weeks (p < 0.05). The production of interleukin (IL)-4 and interferon γ in T cells was not significantly different between the groups, whereas the production of IL-2 was high in the control group. However, there was a significant increase in IFN-γ production by NK cells in the experimental group (at 4 weeks, p < 0.05). ES were medium in the immunological measures (0.53–0.68). No significant difference was observed in the production of proinflammatory cytokines, IL-1β, tumor necrosis factor α, or IL-6 between the groups. In conclusion, STM treatment has a positive effect on subjective pain and quality of life. It also enhanced NK cell proportion and activity, suggesting that STM may be beneficial in the prevention of viral diseases and cancer in old-aged people.

scholarly journals Treatment of refractory post-esophagectomy anastomotic esophageal strictures using temporary fully covered esophageal metal stenting compared to repeated bougie dilation: results of a randomized controlled trial

2019 ◽  
Vol 07 (02) ◽  
pp. E178-E185 ◽  
Author(s):  
W. Kappelle ◽  
J. van Hooft ◽  
M. Spaander ◽  
F. Vleggaar ◽  
M. Bruno ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Current Data ◽  
Metal Stents ◽  
Technical Success Rate ◽  
Kaplan Meier ◽  
Esophageal Strictures ◽  
Significant Difference

Abstract Background and study aims Fully covered self-expanding metal stents (FCSEMS) provide an alternative to bougie dilation (BD) for refractory benign esophageal strictures. Controlled studies comparing temporary placement of FCSES to repeated BD are not available. Patients and methods Patients with refractory anastomotic esophageal strictures, dysphagia scores ≥ 2, and two to five prior BD were randomized to 8 weeks of FCSEMS or to repeated BD. The primary endpoint was the number of BD during the 12 months after baseline treatment. Results Eighteen patients were included (male 67 %, median age 66.5; 9 received metal stents, 9 received BD). Technical success rate of stent placement and stent removal was 100 %. Recurrent dysphagia occurred in 13 patients (72 %) during follow-up. No significant difference was found between the stent and BD groups for mean number of BD during follow-up (5.4 vs. 2.4, P = 0.159), time to recurrent dysphagia (median 36 days vs. 33 days, Kaplan-Meier: P = 0.576) and frequency of reinterventions per month (median 0.3 vs. 0.2, P = 0.283). Improvement in quality of life score was greater in the stent group compared to the BD group at month 12 (median 26 % vs. 4 %, P = 0.011). Conclusions The current data did not provide evidence for a statistically significant difference between the two groups in the number of BD during the 12 months after initial treatment. Metal stenting offers greater improvement in quality of life from baseline at 12 months compared to repeated BD for patients with refractory anastomotic esophageal strictures.

scholarly journals Use of cast immobilisation versus removable brace in adults with an ankle fracture: multicentre randomised controlled trial

BMJ ◽  
2021 ◽  
pp. n1506
Author(s):  
Rebecca Kearney ◽  
Rebecca McKeown ◽  
Helen Parsons ◽  
Aminul Haque ◽  
Nick Parsons ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Ankle Fracture ◽  
Controlled Trial ◽  
Plaster Cast ◽  
Range Of Movement ◽  
Cast Immobilisation ◽  
Significant Difference ◽  
Randomised Controlled

Abstract Objectives To assess function, quality of life, resource use, and complications in adults treated with plaster cast immobilisation versus a removable brace for ankle fracture. Design Multicentre randomised controlled trial. Setting 20 trauma units in the UK National Health Service. Participants 669 adults aged 18 years and older with an acute ankle fracture suitable for cast immobilisation: 334 were randomised to a plaster cast and 335 to a removable brace. Interventions A below the knee cast was applied and ankle range of movement exercises started on cast removal. The removable brace was fitted, and ankle range of movement exercises were started immediately. Main outcome measures Primary outcome was the Olerud Molander ankle score at 16 weeks, analysed by intention to treat. Secondary outcomes were Manchester-Oxford foot questionnaire, disability rating index, quality of life, and complications at 6, 10, and 16 weeks. Results The mean age of participants was 46 years (SD 17 years) and 381 (57%) were women. 502 (75%) participants completed the study. No statistically significant difference was found in the Olerud Molander ankle score between the cast and removable brace groups at 16 weeks (favours brace: 1.8, 95% confidence interval −2.0 to 5.6). No clinically significant differences were found in the Olerud Molander ankle scores at other time points, in the secondary unadjusted, imputed, or per protocol analyses. Conclusions Traditional plaster casting was not found to be superior to functional bracing in adults with an ankle fracture. No statistically difference was found in the Olerud Molander ankle score between the trial arms at 16 weeks. Trial registration ISRCTN registry ISRCTN15537280 .

scholarly journals Effectiveness of acupuncture, ozonio therapy and low-intensity laser in the treatment of temporomandibular dysfunction of muscle origin: a randomized controlled trial

2019 ◽  
Vol 48 ◽  
Author(s):  
Síglia Adriana Campos TORTELLI ◽  
Leonardo SARAIVA ◽  
Daniela Cristina MIYAGAKI
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Laser Therapy ◽  
Controlled Trial ◽  
Mouth Opening ◽  
Life Questionnaire ◽  
Ozone Therapy ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Introduction One of the most common causes of orofacial pain is temporomandibular disorder (TMD). Objective The aim of this study was to compare the effectiveness of acupuncture, ozone therapy and laser therapy in the treatment of muscle TMD patients through a randomized controlled trial. Material and method Twelve professors and postgraduate students from the University of Passo Fundo, diagnosed with TMD, aged between 23 and 50 years old, of both sexes, were evaluated. Individuals were randomly divided into 3 groups: G1: laser therapy, G2: acupuncture, and G3: ozone therapy. TMD diagnostic questionnaires (RDC / TMD), Quality of Life Questionnaire (OHIP-14), Pain Scale (VAS) and maximum mouth opening were applied. Descriptive statistics and percentage were used for sample characterization, which were presented using absolute and relative frequency distributions. Qualitative variables were analyzed with Wilcoxon tests p≤0.05. Result There was no statistically significant difference between treatments. Regarding pain and maximum mouth opening, the groups showed no statistical difference when individually analyzed, but when compared in general, they did (p=0.002 and p=0.003). Conclusion It can be considered that all treatments were able to decrease pain and improve maximal opening capacity related to muscle TMD. It can also be concluded that the TMD-related quality of life, in relation to the pain variable, was generally effective when compared before and after the interventions.

Testosterone replacement for fatigue in male hypogonadic patients with advanced cancer: A preliminary double-blind placebo-controlled trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19643-e19643
Author(s):  
Kalyan Pulivarthi ◽  
Rony Dev ◽  
Jose Garcia ◽  
J. Lynn Palmer ◽  
Eduardo Bruera ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Depression Scale ◽  
T Test ◽  
Testosterone Replacement ◽  
Double Blind ◽  
Significant Difference ◽  
Edmonton Symptom Assessment Scale

e19643 Background: Hypogonadism affects two thirds of men with advanced cancer. Uncontrolled studies show fatigue, anorexia, depression,and insomnia are associated with low testosterone in men with cancer. Testosterone replacement improves quality of life and diminishes fatigue in patients with non-cancer conditions. The primary goal of this study was to evaluate the effect of testosterone replacement on fatigue in hypogonadal males with advanced cancer, by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)at day 29. Methods: Randomized, double-blinded placebo controlled at two centers. Clinic outpatients with advanced cancer, bioavailable testosterone (BT) <70ng/dL, hemoglobin>9g/dL, and moderate to severe fatigue assessed by a score >3/10 on the Edmonton Symptom Assessment Scale (ESAS) were eligible.Contraindications to testosterone therapy or other causes of fatigue such as hypothyroidism, hypercalcemia, or chronic kidney disease excluded subjects. Weight-based intra-muscular testosterone or a sesame seed oil placebo administered every 14 days to achieve a BT level 70-270ng/dL. Initial sample size was for fifty evaluable patients per group. One-sided t test was used to analyze differences in FACIT scores between arms. Results: Accrual was slower than anticipated with a final total of 43 eligible males randomized to testosterone(19) or placebo(24). Neither age nor site was statistically significant (<0.05) between arms. 14 placebo and 12 testosterone treated patients were evaluable for the primary outcome.No statistically significant difference was found for FACIT-F total scores between arms, with a trend for testosterone to improve scores (-5.5±19 for placebo, 3.9±14 for testosterone, p=0.09) using a one-sided t test. Adverse events were similar between groups. There were no significant differences in secondary outcomes of ESAS scores, Hospital Anxiety and Depression Scale, hand-grip or 6 minute walk. Conclusions: Testosterone replacement in hypogonadal male patients with advanced cancer had a trend to improve fatigue and quality of life in this preliminary trial.

Quality of life in RCT of pasireotide to reduce pancreatic complications following resection.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 393-393
Author(s):  
Anne Eaton ◽  
Mithat Gonen ◽  
Paul Jack Karanicolas ◽  
Michael Ian D'Angelica ◽  
Ronald P. DeMatteo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Unmet Need ◽  
Secondary Analysis ◽  
Primary Objective ◽  
Recent Trial ◽  
Double Blind ◽  
Significant Difference ◽  
Eortc Qlq

393 Background: A recent trial demonstrated that prophylactic pasireotide reduces pancreatic complication (PC) rates (primary objective). In this secondary analysis, we describe quality of life (QoL) in this population before and after resection using a standard instrument (the EORTC QLQ-C30) and the EORTC pancreatic cancer module (PAN26), which was recently developed to address the unmet need for QoL assessment in this subpopulation. Also of interest is assessing the association between PC and QoL and testing the hypothesis that pasireotide improves QoL. Methods: We conducted a randomized, double-blind, placebo-controlled trial of preoperative subcutaneous pasireotide in 300 patients undergoing pancreaticoduodenectomy or distal pancreatectomy. Participants completed the C30 and PAN26 preoperatively and on postoperative days 14 and 60. Scores were compared using paired t-tests. Results: All patients completed at least one questionnaire and 87% of patients completed all three. No major differences in QoL were seen between treatment groups so pooled results were reported. A significant worsening of function at 14 days was detected on all PAN26 and C30 function scales except hepatic and emotional functioning (EF), and all C30 symptom scales (all p<.01). These effects lessened by 60 days, but scores remained significantly worse than baseline with the exception of the sexuality, cognitive functioning, nausea and vomiting, insomnia and constipation scales, which returned to near baseline, and EF, which was significantly better than baseline (p=0.03). PC occurred in 45 patients and was associated with worse body image, dyspnea, financial difficulties and physical, role, emotional and social functioning at 14 and 60 days (all p<.05). Conclusions: During the first 14 days following resection, patients can be expected to have a significant decline in QoL. Many symptoms abate by 60 days, and EF improves. Although pasireotide effectively reduced PC, its effect did not appear to translate to improved QoL based on this sample of 300 patients. While PC was associated with worse QoL, most patients in both pasireotide and placebo groups did not experience PC, which may explain why no significant difference in QoL was observed. Clinical trial information: NCT00994110.

Quality of life evaluation of the effect of decapeptyl compared with zoladex preradiotherapy: Final results of randomised controlled trial.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 62-62
Author(s):  
Amit Bahl ◽  
Amarnath Challapalli ◽  
Rosemary Greenwood ◽  
Katrina Hurley ◽  
Rajendra Persad
Keyword(s):  
Quality Of Life ◽  
Treatment Time ◽  
Controlled Trial ◽  
Block Design ◽  
Analysis Of Covariance ◽  
Radical Radiotherapy ◽  
Time Points ◽  
Significant Difference ◽  
Clinically Significant

62 Background: Hormone therapy in combination with radiotherapy is a curative treatment option for prostate cancer (CaP). There is paucity of data regarding quality of life (QoL) evaluation of neoadjuvant Decapeptyl. We reported on the equivalence of cytoreductive efficacy of neoadjuvant Decapeptyl and Zoladex previously. Here we present the final QoL evaluation of the effect of Decapeptyl compared with Zoladex preradiotherapy. Methods: Seventy-one patients with localised CaP who have chosen radical radiotherapy had been randomised by stratified block design, toreceive either Decapeptyl (D: n = 37) or Zoladex (Z: n = 34) with bicalutamide cover. All the patients had subsequent radical radiotherapy and followed up as per departmental protocol. The effect of Decapeptyl and Zoladex on QoL was assessed using EQ5D, QLQ-PR25, QLQ-C30 questionnaires, which were completed at baseline, 6, 10 & 14 weeks after start of therapy. QoL scores were analysed as mean scores over the 4 treatment time points for all domains, controlling for baseline scores using Analysis of Covariance. Results: There was no clinically significant difference or trend towards worsening QoL with either Z or D in the global (EQ5D) and cancer-specific (QLQ-C30) domains. The cancer-specific (QLQ-C30) symptom score also showed no trend towards worsening QoL with either Z or D. Symptom scores in the QLQ-PR25 questionnaire did not show a significant difference between Z and D arms with the exception of hormone symptoms. The hormone symptoms showed an increasing trend over the 4 treatment time points, with those in the Z arm significantly (p = 0.02) more affected (3 points higher on average) than patients in the D arm, despite equivalence in cytoreductive effect and achieving castrate levels of testosterone. Conclusions: There were no clinically significant differences in QoL domains between Zoladex and Decapeptyl, apart from hormones symptoms which were worse with Zoladex. Further validation is required with affect on hormone symptoms as the primary outcome measure. To our knowledge this is the first reported prospective randomised data demonstrating the effect of Zoladex and Decapeptyl, on QoL in the neoadjuvant setting. Clinical trial information: EduraCT: 2008-007028-25.

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