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A Phase II Trial Comparing The Quality Of Life, Tolerability And Toxicity Of PEG Intron With INTRON® A In Patients With Multiple Myeloma PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest A Phase II Trial Comparing The Quality Of Life, Tolerability And Toxicity Of PEG Intron With INTRON® A In Patients With Multiple Myeloma articles that have been published worldwide.
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The phase 3 HYPRO trial compared hypofractionated radiotherapy with conventionally fractionated radiotherapy in patients with localized prostate cancer. Similar 5-year relapse-free survival rates were achieved, whereas non-inferiority of hypofractionation was not confirmed for genitourinary and gastrointestinal toxicity. Here, we present the secondary trial endpoint on patient-reported quality of life.
Two-year toxicity and quality of life (QOL) results are reported from a dose-escalated prostate SABR study for high-risk prostate cancer. Prostate, seminal vesicles, and pelvic lymph nodes were treated using a dose-painting schema up to 40Gy and 25Gy in 5 fractions, respectively, delivered weekly, in combination with androgen deprivation therapy. No grade 3 or higher CTCAE v 3.0 toxicity was noted. EPIC quality of life in all 4 domains was comparable to baseline at 24 months.
Conventionally, evaluation of a new drug, A, is done in three phases. Phase I is based on toxicity to determine a \maximum tolerable dose" (MTD) of A, phase II is conducted to decide whether A at the MTD is promising in terms of response probability, and if so a large randomized phase III trial is conducted to compare A to a control treatment, C; usually based on survival time or progression free survival time. It is widely recognized that this paradigm has many flaws. A recent approach combines the first t...
Metastases with soft tissues invasion, impending fractures or spinal cord compression (complicated bone metastases) represent a common clinical problem in advanced cancers and frequently lead to deterioration of patients' quality of life (QoL). A phase I-II study was planned to define the maximum tolerated dose (MTD) of a short-course radiotherapy (RT) and its efficacy in palliation of complicated bone metastases. A phase I trial was designed with three dose-escalation steps: 16, 18, and 20 Gy. Total dose ...
LBA-001Efficacy, tolerability and impact on quality of life of selective internal radiation therapy (with yttrium-90 resin microspheres) or sorafenib in patients with locally advanced hepatocellular carcinoma: The SARAH trial.
To explore the effects of group singing therapy on depression symptoms and quality of life of patients with stable chronic obstructive pulmonary disease (COPD).
For advanced cancer patients deliberating early clinical trial participation, adequate information about expected effect on quality of life (HRQoL) and hope, may support decision making. The aim was to assess the potential relation of HRQoL to eligibility for phase-I trial participation, and to observe the variations in patient-reported outcomes. Patients completed questionnaires at preconsent (n = 124), baseline (n = 96), and after first evaluation of a phase-I trial (n = 76). The Mann-Whitney U test...
This is the first report on a trial using a Kit D816V targeting drug in indolent systemic mastocytosis. The results indicate midostaurin to be effective in reducing symptom severity and improving quality of life.
Quality of Life, Glycemic Control, Safety and Tolerability Associated with Liraglutide or Insulin Initiation in Patients with Type 2 Diabetes in Germany: Results from the Prospective, Non-interventional LIBERTY Study.
To assess quality of life, glycemic control, and safety/tolerability associated with liraglutide versus insulin initiation in patients with type 2 diabetes in Germany.
Limited pelvic nodal relapse of prostatic cancer is a paramount challenge for locoregional salvage treatments. Salvage whole pelvis radiotherapy as considered in the BLINDED trial, is an attractive option but with concerns about its toxicity. This article describes early toxicity with the technique.
Polyethylene glycol (PEG) bowel preparations are widely used for precolonoscopy bowel cleansing. This phase 3 trial assessed the efficacy, safety, and tolerability of the novel 1 L PEG-based NER1006 vs. sodium picosulfate plus magnesium citrate (SP + MC) in day-before dosing.
Purpose To evaluate acute and late genitourinary (GU) and gastrointestinal (GI) toxicity and the biochemical control of pure hypofractionated radiotherapy (without acceleration) for the treatment of prostate cancer. Methods and materials This phase II prospective trial evaluated low-risk and intermediate-risk prostate cancer patients who received hypofractionated radiotherapy. Fifty-three patients with low-risk prostate cancer received 50 Gy in 15 fractions, 156 patients with intermediate-risk prostate canc...
Irritable bowel syndrome with diarrhea (IBS-D) significantly impacts health-related quality of life (HRQOL). This post hoc analysis of two phase III trials evaluated the effects of eluxadoline treatment on disease-specific HRQOL among patients with IBS-D.
Endometriosis and quality of life has been the subject of much research, however, there is little consensus on how best to evaluate quality of life in endometriosis, resulting in many and diverse scales being used. In our study, we aim to identify quality of life scales used in endometriosis, to review their strengths and weaknesses and to establish what would define an ideal scale in the evaluation of endometriosis-related quality of life.
Oligometastatic disease has emerged as a potentially curable state in the spectrum of cancer progression. Aggressive local therapy such as stereotactic ablative radiation therapy (SABR) may improve oncologic outcomes. Herein, we report the initial oncologic outcomes and patient-reported quality of life (PR-QoL) from a phase II multi-center trial for patients with oliogmetastatic disease.
SBRT is an emerging option for localized prostate cancer. However, there are no standard dosimetric guidelines and normal tissue tolerances for extreme hypofractionation are not well defined. We analyzed dosimetric correlations with patient-reported urinary and bowel quality of life (QOL) on a prospective trial.
This randomised clinical trial aimed to compare the impact of two different tooth replacement strategies for partially dentate older patients namely; removable partial dentures (RPDs) and functionally orientated treatment based on the shortened dental arch (SDA) concept, on Oral Health-related Quality of Life (OHrQOL).
Phase I clinical trials are the first step in drug development to test a new drug or drug combination on humans. Typical designs of Phase I trials use toxicity as the primary endpoint and aim to find the maximum tolerable dosage. However, these designs are poorly applicable for the development of cancer therapeutic vaccines because the expected safety concerns for these vaccines are not as much as cytotoxic agents. The primary objectives of a cancer therapeutic vaccine phase I trial thus often include deter...
Preclinical evidence indicates that the bone marrow microenvironment provides a protective niche for leukemic stem cells, allowing them to evade the effects of BCR-ABL tyrosine kinase inhibitors (TKIs), but that targeting of the JAK-STAT pathway with the JAK2 inhibitor ruxolitinib increases TKI-induced apoptosis. A phase I clinical trial (NCT01702064) investigated the tolerability and safety of treating chronic-phase chronic myeloid leukemia patients with ruxolitinib in combination with the BCR-ABL TKI nilo...
In a previous randomized controlled trial it has been demonstrated that arm compression sleeves worn immediately after breast cancer surgery, including axillary lymph node removal in addition to physical therapy are able to reduce the occurrence of early postoperative swelling and of arm lymphedema up to 1 year and to improve quality of life. The aim of the present investigation was to check the further development of the arm swelling in patients using compression sleeves or not, and to compare the quality ...
Herpes zoster (HZ) and its related complications are associated with significant medical burden, which negatively impacts patients' quality-of-life (QoL) and daily functioning. The recently licensed recombinant zoster vaccine (RZV) offers high efficacy, but is associated with local and systemic reactions. This study assessed the impact of RZV upon the QoL and daily functioning of participants and implications for caregivers.
To explore service user experiences of a 9-month cognitive behavioural therapy for command hallucinations in the context of a randomised controlled trial including their views on acceptability and tolerability of the intervention.
The REGENT-VSEL trial demonstrated a neutral effect of transendocardial injection of autologous bone marrow (BM)-derived CD133+ in regard to myocardial ischemia. The current sub-analysis of the REGENT VSEL trial aims to assess the effect stem cell therapy has on quality of life (QoL) in patients with refractory angina.
Glioblastoma is the most common and aggressive primitive brain tumor in adults. Temozolomide (TMZ) administered daily with radiation therapy, followed by adjuvant TMZ has become the standard treatment. Although TMZ treatment has been considered to have a low toxicity profile, studies have noted the development of a severe myelosuppression, especially during the concomitant treatment; this toxicity may in some cases be prolonged and consequently treatment must be definitively discontinued. We analyzed two ca...