Metronomic capecitabine as adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma: A phase 3, multicenter, randomized controlled trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6003-6003
Author(s):  
Jun Ma ◽  
Yu-Pei Chen ◽  
Ying Sun ◽  
Qin Zhou ◽  
Kun-Yu Yang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Nasopharyngeal Carcinoma ◽  
Adjuvant Therapy ◽  
Standard Therapy ◽  
Therapy Group ◽  
Controlled Trial ◽  
High Rate ◽  
Standard Therapy Group ◽  
Multicenter Randomized Controlled Trial

6003 Background: Patients suffering from locoregionally advanced nasopharyngeal carcinoma (NPC) commonly develop disease recurrence, despite a high rate of complete clinical remission after standard of care (concurrent cisplatin-radiotherapy, with or without induction chemotherapy). The benefit of additional adjuvant chemotherapy remains unclear. Methods: Patients with high-risk locoregionally advanced NPC (stage III to IVA, excluding T3-4N0 and T3N1), and with no locoregional disease or distant metastasis after definitive chemoradiotherapy, were eligible. They were randomly assigned (1:1) within 12 to 16 weeks after the last radiation dose to receive either capecitabine at a dose of 650 mg/m2 twice daily for 1 year (metronomic capecitabine group) or observation (standard-therapy group). The primary end point was recurrence-free survival (RFS). The calculated sample size was 201 per group, with an 80% power (two-sided α 0.05) to detect a target hazard ratio (HR) of 0.52. Results: A total of 406 patients underwent randomization, comprising 204 in the metronomic capecitabine group and 202 in the standard-therapy group. After a median follow-up of 36 months (corresponding to 43 months when calculated from the start of standard therapy), the estimated 3-year RFS was 85.9% in the metronomic capecitabine group, as compared with 76.5% in the standard-therapy group (intention-to-treat population; HR 0.51, 95% confidence interval 0.32–0.81; P = 0.003). The incidence of grade 3 adverse events was 17.4% in the metronomic capecitabine group and 5.5% in the standard-therapy group; hand-foot syndrome was the most common adverse event related to capecitabine (9.0%). One grade 4 neutropenia occurred in the metronomic capecitabine group. Neither group sufferd from treatment-related deaths. During treatment, there was no clinically meaningful deterioration of health-related quality of life associated with the use of metronomic adjuvant capecitabine. Conclusions: The addition of metronomic capecitabine as adjuvant therapy to chemoradiotherapy significantly improved RFS in locoregionally advanced NPC, with a manageable safety profile and no compromise to quality of life. Clinical trial information: NCT02958111. [Table: see text]

scholarly journals Amelioration of mild and moderate depression through Pranic Healing as adjuvant therapy: randomised double-blind controlled trial

2017 ◽  
Vol 26 (1) ◽  
pp. 82-87 ◽  
Author(s):  
R Rajagopal ◽  
Srikanth N Jois ◽  
Sumanth Mallikarjuna Majgi ◽  
MN Anil Kumar ◽  
HB Shashidhar
Keyword(s):  
Quality Of Life ◽  
Adjuvant Therapy ◽  
Mental Disorder ◽  
Controlled Trial ◽  
Antidepressant Drug ◽  
Double Blind ◽  
Average Decrease ◽  
Moderate Depression ◽  
Post Assessment

Objectives: Depression is a mental disorder, affecting the quality of life. Our study explores the efficacy of Pranic Healing (PH), as an adjuvant therapy in treating depression Methods: In this randomised double-blind controlled trial, 52 participants with a mean age of 34.4 years, with mild to moderate depression were assessed using the Hamilton Depression Rating (HAM-D) scale during the 5-week study. Both Medication + PH (MedPH) and Medication + Mock PH (MedMockPH) groups comprising 26 members received Pranic and mock healing lasting 20 minutes per session respectively once a week for 4 weeks, along with the antidepressant drug. Results: The average decrease in HAM-D score in MedPH was median 11 (Interquartile Range (IQR) 7–12) and was significantly higher compared with the MedMockPH group median 6.5 (IQR 3–9). At pre-assessment, both groups had 8 cases of mild and 18 cases of moderate depression. At post-assessment, HAM-D showed that the improvement in depression category was seen in 69.2% of participants in the MedMockPH group and 100% in MedPH group. Conclusions: These results give first the evidence that PH can aid as an adjuvant therapy for depressed people.

Comparison of kinesio taping and cold therapy in patients with total knee arthroplasty: A randomized controlled trial

2021 ◽  
pp. 026921552110491
Author(s):  
Ertugrul Yuksel ◽  
Bayram Unver ◽  
Vasfi Karatosun
Keyword(s):  
Quality Of Life ◽  
Muscle Strength ◽  
Range Of Motion ◽  
Therapy Group ◽  
Controlled Trial ◽  
Control Group ◽  
Functional Level ◽  
Kinesio Taping ◽  
Cold Therapy

Objective To investigate the effects of kinesio taping and cold therapy on pain, edema, range of motion, muscle strength, functional level and quality of life in patients with total knee arthroplasty. Design Randomised controlled trial. Setting A university hospital. Subjects One-hundred patients were included. Intervention Patients were allocated into three groups; control group, kinesio group and cold therapy group. The control group received a standard rehabilitation program. Kinesio taping group received two fan-shaped kinesio taping bands and cold therapy group received cold packs in addition to the standard rehabilitation program. Main measures The outcome measures were pain, edema, range of motion, muscle strength, functional level and quality of life. Participants were assessed at preoperative, discharge and postoperative third month. Results The groups were similar at preoperative. A significant difference was determined in terms of pain in kinesio taping group compared to the control group at the discharge. Cold therapy was efficient in reducing postoperative swelling but kinesio taping had no significant effects on swelling control. There was no difference between the groups in terms of range of motion, muscle strength, functional level and quality of life. The groups were similar in all parameters at the postoperative third month measurements. Conclusion Fan-shaped kinesio taping is an effective technique in terms of postoperative pain relief. Cold therapy is an effective method in terms of edema control. Kinesio taping and cold therapy has no specific beneficial effect on functional level, muscle strength and quality of life compared to control group.

scholarly journals Effectiveness of a Randomized Controlled Trial of Individual Reminiscence Therapy on Cognition, Mood and Quality of Life in Azorean Older Adults with Neurocognitive Disorders

2021 ◽  
Vol 10 (22) ◽  
pp. 5395
Author(s):  
Susana I. Justo-Henriques ◽  
Enrique Pérez-Sáez ◽  
João L. Alves Apóstolo ◽  
Janessa O. Carvalho
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Neurocognitive Disorders ◽  
Cognitive Stimulation ◽  
Reminiscence Therapy ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Reminiscence therapy (RT) is a form of cognitive stimulation therapy that incorporates discussion of past activities, events, and experiences to stimulate individual memories; it has had some success in treating persons with neurocognitive disorders. This research aims to evaluate the ability of individual RT, using a simple reminiscence format, to improve the overall cognitive function, memory, executive functions, emotional status, and quality of life in older adults with neurocognitive disorders who received social care and support services. A multicenter randomized controlled trial was completed in the Azores archipelago (an independent region of Portugal) using repeated measures (pre-intervention, post-intervention, and follow-up). The intervention group underwent individual RT sessions, twice weekly for 13 weeks, while the control group completed regular activities administered as part of their program. Results did not reveal any significant differences between the intervention and control groups. While results did not reveal significant effects, a number of historical and contextual factors are considered as possible explanations for the lack of effects—namely, data collection occurring during the COVID-19 global pandemic, participant cohort effects, and therapist heterogeneity.

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.

scholarly journals Hippotherapy for patients with multiple sclerosis: A multicenter randomized controlled trial (MS-HIPPO)

2017 ◽  
Vol 24 (10) ◽  
pp. 1375-1382 ◽  
Author(s):  
Vanessa Vermöhlen ◽  
Petra Schiller ◽  
Sabine Schickendantz ◽  
Marion Drache ◽  
Sabine Hussack ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mean Difference ◽  
Control Group ◽  
Health Score ◽  
Multicenter Randomized Controlled Trial

Background: Evidence-based complementary treatment options for multiple sclerosis (MS) are limited. Objective: To investigate the effect of hippotherapy plus standard care versus standard care alone in MS patients. Methods: A total of 70 adults with MS were recruited in five German centers and randomly allocated to the intervention group (12 weeks of hippotherapy) or the control group. Primary outcome was the change in the Berg Balance Scale (BBS) after 12 weeks, and further outcome measures included fatigue, pain, quality of life, and spasticity. Results: Covariance analysis of the primary endpoint resulted in a mean difference in BBS change of 2.33 (95% confidence interval (CI): 0.03–4.63, p = 0.047) between intervention ( n = 32) and control ( n = 38) groups. Benefit on BBS was largest for the subgroup with an Expanded Disability Status Scale (EDSS) ⩾ 5 (5.1, p = 0.001). Fatigue (−6.8, p = 0.02) and spasticity (−0.9, p = 0.03) improved in the intervention group. The mean difference in change between groups was 12.0 ( p < 0.001) in physical health score and 14.4 ( p < 0.001) in mental health score of Multiple Sclerosis Quality of Life-54 (MSQoL-54). Conclusion: Hippotherapy plus standard care, while below the threshold of a minimal clinically important difference, significantly improved balance and also fatigue, spasticity, and quality of life in MS patients.

scholarly journals Prevention of relapses with levamisole as adjuvant therapy in children with a first episode of idiopathic nephrotic syndrome: study protocol for a double blind, randomised placebo-controlled trial (the LEARNS study)

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e027011 ◽  
Author(s):  
Floor Veltkamp ◽  
Djera H Khan ◽  
Christa Reefman ◽  
Susan Veissi ◽  
Hedy A van Oers ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Nephrotic Syndrome ◽  
Adjuvant Therapy ◽  
Study Protocol ◽  
Standard Therapy ◽  
Idiopathic Nephrotic Syndrome ◽  
First Episode ◽  
Double Blind ◽  
Frequent Relapses

IntroductionIdiopathic nephrotic syndrome (INS) is characterised by a high relapse rate up to 80% after initial response to standard therapy with corticosteroids. Steroid toxicity is common and causes a great burden of disease that negatively influences the health-related quality of life (HRQoL). Recently, studies have shown that levamisole, an anthelminthic drug, significantly improves relapse-free survival in children with frequent relapses or steroid dependency. Compared with other steroid-sparing drugs, levamisole has relatively few side effects. We hypothesise that adding levamisole to standard therapy with corticosteroids in children with a first episode of INS will prevent relapses, decrease cumulative dosage of steroids used and improve HRQoL. This paper presents the study protocol for the LEARNS study (LEvamisole as Adjuvant therapy to Reduce relapses of Nephrotic Syndrome).Methods and analysisAn international, double-blind, placebo-controlled randomised trial will be conducted in 20 participating hospitals in the Netherlands and Belgium. Participants (n=92) with a first episode of INS, aged 2–16 years, who achieve remission after 4 weeks of oral prednisolone will be randomly assigned (1:1) to receive either levamisole 2.5 mg/kg alternate day or placebo added to prednisolone (18-week tapering schedule) for a total of 24 weeks. Follow-up will be until 2 years after first presentation. Additionally, parents and/or children will fill out five HRQoL questionnaires. Primary outcome of the LEARNS study is occurrence of relapses within 12 months after first presentation. Secondary outcomes include time to first relapse, cumulative steroid dose after 2 years, safety parameters and quality of life scores.Ethics and disseminationThe trial was approved by the Medical Ethical Committee. Results of the study will be published in a peer-reviewed journal.Trial registration numberNL6826, 2017-001025-41

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