scholarly journals A Randomized Controlled Open-Label Pilot Study of Simvastatin Addition to Whole-Brain Radiation Therapy in Patients With Brain Metastases

2016 ◽  
Vol 24 (6) ◽  
pp. 521-528 ◽  
Author(s):  
Manal El-Hamamsy ◽  
Hesham Elwakil ◽  
Amr S. Saad ◽  
May A. Shawki
Keyword(s):  
Quality Of Life ◽  
Radiation Therapy ◽  
Pilot Study ◽  
Control Group ◽  
Open Label ◽  
Randomized Controlled ◽  
Whole Brain Radiation ◽  
Radiological Response ◽  
Brain Radiation

Statins have been reported to have a potential radiosensitizing effect that has not been evaluated in clinical trials. The aim of this study was to evaluate the efficacy and safety of simvastatin in addition to whole-brain radiation therapy (WBRT) in patients with brain metastases (BM). A prospective randomized, controlled, open-label pilot study was conducted on 50 Egyptian patients with BM who were randomly assigned to receive 30-Gy WBRT (control group: 25 patients) or 30 Gy WBRT + simvastatin 80 mg/day for the WBRT period (simvastatin group: 25 patients). The primary outcome was radiological response at 4 weeks after WBRT. Secondary outcomes were 1-year progression-free survival (PFS), 1-year overall survival (OS), and health-related quality of life (HRQL) that was assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and its brain module (BN-20), at baseline, after WBRT, and 4 weeks after WBRT. The addition of simvastatin was tolerated. Twenty-one patients were not evaluated for radiological response because of death (n = 16), noncompliance to follow-up (n = 4), and clinical deterioration (n = 1). Response rates were 60% and 78.6% (p = 0.427), 1-year PFS rates were 5.2% and 17.7% (p = 0.392), and 1-year OS rates were 12% and 8% (p = 0.880) for the control group and simvastatin group, respectively. Nonsignificant differences were found between the two arms regarding HRQL scales. The addition of simvastatin 80 mg/day did not improve the clinical outcomes of patients with BM receiving WBRT.

Symptoms and quality of life in patients with brain metastases receiving whole-brain radiation therapy

2016 ◽  
Vol 24 (11) ◽  
pp. 4747-4759 ◽  
Author(s):  
Erin Wong ◽  
Liying Zhang ◽  
Leigha Rowbottom ◽  
Nicholas Chiu ◽  
Leonard Chiu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Radiation Therapy ◽  
Brain Metastases ◽  
Whole Brain Radiation Therapy ◽  
Whole Brain ◽  
Whole Brain Radiation ◽  
Brain Radiation

scholarly journals Additional Therapy with a Mistletoe Product during Adjuvant Chemotherapy of Breast Cancer Patients Improves Quality of Life: An Open Randomized Clinical Pilot Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Wilfried Tröger ◽  
Zdravko Ždrale ◽  
Nevena Tišma ◽  
Miodrag Matijašević
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Pilot Study ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Pilot Trial ◽  
Control Group ◽  
Breast Cancer Patients ◽  
Open Label

Background. Breast cancer patients receiving adjuvant chemotherapy often experience a loss of quality of life. Moreover chemotherapy may induce neutropenia. Patients report a better quality of life when additionally treated with mistletoe products during chemotherapy.Methods. In this prospective randomized open-label pilot study 95 patients were randomized into three groups. All patients were treated with an adjuvant chemotherapy. The primary objective of the study was quality of life, the secondary objective was neutropenia. Here we report the comparison of HxA (n= 34) versus untreated control (n= 31).Results. In the explorative analysis ten of 15 scores of the EORTC QLQ-C30 showed a better quality of life in the HxA group compared to the control group (P<0.001toP=0.038in Dunnett-T3 test). The difference was clinically relevant (difference of at least 5 points, range 5.4–12.2) in eight of the ten scores. Neutropenia occurred in 7/34 HxA patients and in 8/31 control patients (P= 0.628).Conclusions. This pilot study showed an improvement of quality of life by treating breast cancer patients with HxA additionally to CAF. Although the open design may be a limitation, the findings show the feasibility of a confirmatory study using the methods described here.

scholarly journals Quality-of-life trajectories after stereotactic radiosurgery for brain metastases

2020 ◽  
pp. 1-9
Author(s):  
Adomas Bunevicius ◽  
Karen Lavezzo ◽  
Leah Shabo ◽  
Jesse McClure ◽  
Jason P. Sheehan
Keyword(s):  
Quality Of Life ◽  
Radiation Therapy ◽  
Brain Metastasis ◽  
Brain Metastases ◽  
Cancer Patients ◽  
Whole Brain Radiation ◽  
Anxiety Depression ◽  
Brain Radiation

OBJECTIVEQuality of life (QOL) is an important endpoint measure of cancer treatment. The authors’ goal was to evaluate QOL trajectories and prognostic value in cancer patients treated with stereotactic radiosurgery (SRS) for brain metastases.METHODSPatients who underwent Gamma Knife radiosurgery (GKRS) between January 2016 and November 2019 were prospectively evaluated for QOL using the EQ-5D-3L questionnaire before SRS and at follow-up visits. Only patients who had pre-SRS and at least 1 post-SRS QOL assessment were considered.RESULTSFifty-four cancer patients underwent 109 GKRS procedures. The first post-SRS visit was at a median of 2.59 months (range 0.13–21.08 months), and the last post-SRS visit was at 14.72 months (range 2.52–45.21 months) after SRS. There was no statistically significant change in the EQ-5D index score (p = 0.539) at the first compared with last post-SRS visit. The proportion of patients reporting some problems on the EQ-5D dimension of self-care increased during the course of follow-up from 9% (pre-SRS visit) to 18% (last post-SRS visit; p = 0.03). The proportion of patients reporting problems on the EQ-5D dimensions of mobility, usual activities, pain/discomfort, and anxiety/depression remained stable during the course of follow-up (p ≥ 0.106). After adjusting for clinical variables, a higher recursive partitioning analysis (RPA) class (i.e., worse prognostic category) was independently associated with greater odds for EQ-5D index score deterioration (p = 0.050). Upfront whole-brain radiation therapy predicted deterioration of the EQ-5D self-care (p = 0.03) and usual activities (p = 0.024) dimensions, while a greater number of lesions predicted deterioration of the EQ-5D anxiety/depression dimension (p = 0.008). A lower pre-SRS EQ-5D index was associated with shorter survival independently from clinical and demographic variables (OR 18.956, 95% CI 2.793–128.64; p = 0.003).CONCLUSIONSQOL is largely preserved in brain metastasis patients treated with SRS. Higher RPA class, upfront whole-brain radiation therapy, and greater intracranial disease burden are independent predictors of post-SRS QOL deterioration. Worse pre-SRS QOL predicts shorter survival. Assessment of QOL is recommended in brain metastasis patients managed with SRS.

scholarly journals Efficacy of Bimin decoction for patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Jingyi Zhao ◽  
Xinyu Yan ◽  
Jianqing Gai ◽  
Jinshuai Han ◽  
Hong Zhang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Controlled Trial ◽  
Control Group ◽  
Nasal Resistance ◽  
Open Label ◽  
Randomized Controlled

Abstract Background Allergic rhinitis (AR) is a common allergic disease. It affects people worldwide and traditional Chinese medicine is becoming popular among AR patients because it has a definite clinical effect and there are few adverse reactions. Lung qi deficiency and cold syndrome (LQDCS) is a frequent type of AR, and the Chinese herbal medicine bimin decoction (BMD) is prescribed for it. This study compared the clinical efficacy of BMD for AR patients with LQDCS to the conventional medicine loratadine and fluticasone nasal spray. Methods The study was an open-label non-inferiority randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were randomly allocated in a 1:1 ratio to the BMD group or the control group by the central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. In total, 98 participants completed the study (BMD group n = 51 and control group n = 47). Patients in the BMD group received BMD while those in the control group received fluticasone nasal spray and loratadine tablets for 4 weeks. The primary outcome was the change in the Total Nasal Symptom Score (TNSS) between the baseline and the end of treatment. Changes in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), nasal resistance, and acoustic rhinometry parameters were secondary outcomes. All side effects due to the treatments were recorded. Results After the 4-week treatment, the total TNSS was significantly reduced in both groups compared to the baseline (P <  0.05). No significant between-groups differences were observed for changes in TNSS scores [− 0.298 (95% confidence interval −0.640 to 0.140)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly (P <  0.001) from baseline, though a more obvious reduction was observed for the BMD group (P <  0.001). There were no significant differences in nasal resistance, nasal volume, or nasal minimum cross-sectional area between groups after treatment (P > 0.05). Conclusions These findings indicate that BMD helps relieve the symptoms of perennial AR and improves rhinitis-related quality of life. Our study indicates that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS. Trial registration Chinese Clinical Trial Registry, ChiCTR-INR-16010063. Registered on 2 December 2016.

scholarly journals Inquiry Based Stress Reduction (IBSR) Improves Overall Stuttering Experience among Adults Who Stutter: A Randomized Controlled Trial

2021 ◽  
Vol 10 (10) ◽  
pp. 2187
Author(s):  
Omrit Feldman ◽  
Eran Goldstien ◽  
Benjamin Rolnik ◽  
Ariel B. Ganz ◽  
Shahar Lev-Ari
Keyword(s):  
Quality Of Life ◽  
Stress Reduction ◽  
Satisfaction With Life ◽  
Psychological Flexibility ◽  
Well Being ◽  
The United States ◽  
Control Group ◽  
Randomized Controlled ◽  
Adults Who Stutter

Stuttering is a speech disorder that can cause disturbances in the timing and flow of speech. In addition to being a communication disorder, stuttering is often accompanied by a reduction in the quality of life and has impacts on social status, mental well-being, self-acceptance, and the chances of integration into the labor market. The Inquiry Based Stress Reduction (IBSR) program, developed in the United States by Byron Katie in 1986, is the clinical application of “The Work” method (Thework.com) and represents an emerging mindfulness and cognitive-reframing method. IBSR has been demonstrated to improve mental health and well-being in adults and may alleviate psychological and psychosocial symptoms of stuttering. The purpose of this trial was to examine the effect of a 12-week IBSR intervention on the overall stuttering experience and indicators of anxiety, psychological flexibility, and well-being among adults who stutter (AWS). This study was a randomized controlled clinical trial. Participants were randomized to IBSR (n = 28) and control (n = 28) groups. Validated questionnaires of overall stuttering experience (OASES-A), anxiety (STAI), psychological flexibility (PFQ), and satisfaction with life (SWLS) were completed before, after, and one month after the intervention. An intention-to-treat approach was implemented for analysis. Our results show that participants in the IBSR intervention group exhibited a greater improvement in their overall stuttering experience as compared to the control group, as well as in general information on stuttering awareness and perception, reactions to stuttering, communication in daily situations, and quality of life. In addition, we found a greater reduction in anxiety levels and an increase in satisfaction-with-life scores in the IBSR group. These results indicate that IBSR can improve the overall stuttering experience.

scholarly journals Asthma in Adolescents: A Randomized, Controlled Trial of an Asthma Program for Adolescents and Young Adults with Severe Asthma

2002 ◽  
Vol 9 (4) ◽  
pp. 253-259 ◽  
Author(s):  
Robert L Cowie ◽  
Margot F Underwood ◽  
Cinde B Little ◽  
Ian Mitchell ◽  
Sheldon Spier ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Asthma Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Disease Specific

BACKGROUND: Asthma is common and is often poorly controlled in adolescent subjects.OBJECTIVE: To determine the impact of an age-specific asthma program on asthma control, particularly on exacerbations of asthma requiring emergency department treatment, and on the quality of life of adolescents with asthma.METHODS: The present randomized, controlled trial included patients who were 15 to 20 years of age and had visited emergency departments for management of their asthma. The interventional group attended an age-specific asthma program that included assessment, education and management by a team of asthma educators, respiratory therapists and respiratory physicians. In the control group, spirometry was performed, and the patients continued to receive usual care from their regular physicians. The outcomes were assessed by a questionnaire six months after entry into the study.RESULTS: Ninety-three subjects entered the study and were randomly assigned to the intervention or control group. Of these, only 62 patients were available for review after six months. Subjects in both the control and the intervention groups showed a marked improvement in their level of asthma control, reflected primarily by a 73% reduction in the rate of emergency department attendance for asthma. Other indexes of disease control, including disease-specific quality of life, as assessed by questionnaires, were improved. There was, however, no discernible difference between the subjects in the two groups, with the exception of an improvement in favour of the intervention group in the symptom (actual difference 0.7, P=0.048) and emotional (actual difference 0.8, P=0.028) domains of the asthma quality of life questionnaire. The overall quality of life score favoured the intervention group by a clinically relevant difference of 0.6, but this difference did not reach statistical significance (P=0.06).CONCLUSIONS: Although all subjects demonstrated a significant improvement in asthma control and quality of life, the improvement attributable to this intervention was limited to two domains in disease-specific quality of life.

A randomized controlled clinical trial to evaluate safety and efficacy of a Unani formulation in the management of Kalaf (Melasma)

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Ifra Abdul Qaiyyum ◽  
Mohammad Nawab ◽  
Munawwar Husain Kazmi
Keyword(s):  
Quality Of Life ◽  
Test Group ◽  
Control Group ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
End Point ◽  
Intergroup Comparison ◽  
And Control ◽  
Change In Mean

Abstract Objectives Kalaf (Melasma) is an acquired facial hypermelanism. It has direct impact on patient’s quality of life and leads to development of various personality disorders. Lack of effective treatment and recurrences have drawn the attention of researcher to find alternative treatment. This study aimed to evaluate safety and efficacy of a topical Unani formulation in the management of melasma. Methods We conducted a prospective randomized controlled clinical study on the participants diagnosed with melasma. The participants (n=72) randomized into test (n=36) and control (n=36) groups. Sixty participants (n=30 in each group) completed the duration of therapy. The participants of the test group were treated with a classical Unani formulation and control group with hydroquinone 4%. The primary end point was change in mean MASI score and secondary end point was improvement in quality of life after eight weeks of treatment. Results The Unani formulation reduced 40.5% mean MASI score (17.31 ± 9.58 to 10.28 ± 5.92) in comparison to 32% reduction in mean MASI score (20.58 ± 9.49 to 13.92 ± 7.38) in the control group after eight weeks of treatment. When comparing with baseline the difference in MASI score was found statistically significant in both groups (p<0.05). On intergroup comparison, the change in MASI score between both groups was not statistically significant (p>0.05). In addition, MQOL and DQLI also improved significantly in both groups. Conclusions This study concluded that the Unani formulation and the control drug were equally effective and safer in the management of melasma.

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