Subjective symptoms and quality of life in healthy subjects during a phase I study

1996 ◽  
Vol 51 (3-4) ◽  
pp. 215-219 ◽  
Author(s):  
R. Schüppel ◽  
B. Boos ◽  
G. Bühler ◽  
M. Lataster ◽  
T. Peters
Keyword(s):  
Quality Of Life ◽  
Phase I ◽  
Healthy Subjects ◽  
Phase I Study ◽  
Subjective Symptoms

scholarly journals Quality-of-Life Priorities in Patients with Thyroid Cancer: A Multinational European Organisation for Research and Treatment of Cancer Phase I Study

Thyroid ◽  
2016 ◽  
Vol 26 (11) ◽  
pp. 1605-1613 ◽  
Author(s):  
Susanne Singer ◽  
Olga Husson ◽  
Iwona M. Tomaszewska ◽  
Laura D. Locati ◽  
Naomi Kiyota ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Thyroid Cancer ◽  
Phase I ◽  
Phase I Study ◽  
European Organisation

scholarly journals A phase I study of MR-HIFU hyperthermia (HT) with radiation (RT) and chemotherapy (CT) for recurrent rectal cancer.

2019 ◽  
Vol 5 (suppl) ◽  
pp. 78-78
Author(s):  
William Chu ◽  
Yuexi Huang ◽  
Samuel Pichardo ◽  
Robert Staruch ◽  
Ari Partanen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rectal Cancer ◽  
Phase I ◽  
Phase I Study ◽  
Intraoperative Complications ◽  
Cancer Control ◽  
Late Toxicity ◽  
Recurrent Rectal Cancer ◽  
Cumulative Number

78 Background: HT may improve cancer control and quality of life by sensitizing tumors to RT and CT. Inoperable recurrent rectal cancer has marginal outcomes with current retreatment regimens. We report the results from a first-in-human phase I study of MR-HIFU hyperthermia combined with RT and CT for recurrent rectal cancer. Methods: This ethics-approved study enrolled 6 patients fit for re-irradiation and chemotherapy; and with a MRI-visible and HIFU-accessible lesion. Patients received 30.6 Gy (17 fractions) and daily oral capecitabine, plus MR-HIFU HT immediately before RT on days 1, 8, and 15. Primary objectives were safety (acute toxicity) and treatment feasibility. Secondary objectives included late toxicity, pain palliation, quality of life, and radiologic response. HT was delivered with the Sonalleve MR-HIFU system on a 3T MRI. MR-based feedback control parameters were prescribed to achieve a mean temperature of 42.5°C in an 18 mm diameter target region for 30 minutes without exceeding 45°C. Results: One patient withdrew after completing 1/3 HT sessions due to scheduling and sedation difficulties. Five patients completed HT, RT and CT. There were no intraoperative complications, no adverse events or unintended tissue damage attributable to HT, RT, or CT. Table shows the best single continuous HT and mean temperatures (T90, T10), cumulative time in range (TIR), cumulative number of equivalent minutes at 43oC(CEM43) and day 90 imaging response. Sonication and MRI suite times were 36±13 and 226±78min. Conclusions: MR-HIFU HT was safely delivered in patients with recurrent rectal cancer. Treatment planning and patient set-up times decreased while beam-on time increased with experience. MR-HIFU HT combined with RT and CT appears feasible for primary tumours. Clinical trial information: NCT02528175. [Table: see text]

Phase I study of SNK01 (autologous non-genetically modified natural killer cells with enhanced cytotoxicity) in refractory metastatic solid tumors.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e15024-e15024
Author(s):  
Sant P. Chawla ◽  
Katherine M Kim ◽  
Victoria S. Chua ◽  
Omid Jafari ◽  
Paul Y. Song
Keyword(s):  
Quality Of Life ◽  
Phase I ◽  
Nk Cells ◽  
Cancer Patients ◽  
Solid Tumors ◽  
Phase I Study ◽  
Nk Cell ◽  
Heavily Pretreated ◽  
Tumor Types

e15024 Background: Natural Killer (NK) cells possess the innate ability to detect transformed cancer cells and kill them, thus playing a key role in cancer immunosurveillance and antitumor immunity. In general, prior NK cell therapies have not shown efficacy in solid tumors and the expansion of NK cells in cancer patients to clinically therapeutic doses is quite challenging, making allogenic preferable to autologous treatment. SNK01 is a first-in-kind, autologous non-genetically modified NK cell therapy with enhanced cytotoxicity which can be consistently produced even from heavily pretreated cancer patients, and has been shown to have efficacy against numerous solid tumor types in preclinical studies. Methods: In this single-arm Phase I study (NCT03941262) to investigate the safety and efficacy of SNK01, patients with refractory metastatic solid tumors were treated in a 3 + 3 dose escalation study with five weekly infusions of SNK01 at 1, 2, or 4 x 109 cells per infusion. Primary endpoint is safety and quality of life (QoL), and secondary endpoint is objective response rate (ORR). Results: Seven of nine planned patients have been enrolled up to date and five have completed treatment. All patients have rapidly progressive metastatic disease and have received an average of five lines of prior therapy. Tumor types include one non-small lung cancer, one colorectal cancer, and five sarcomas. Median age is 52 (32-62). All patients have had successful expansion and cytotoxic enhancement of their NK cells. Three patients have completed 1 x 109 SNK01 and two patients have completed 2 x 109 SNK01. There have been no adverse events according to NCI-CTCAE v 5.0 or any cytokine release syndrome, and all patients have reported an overall improvement in QoL. At week 9, three of three patients at the 1 x 109 dose and one of two at the 2 x 109 achieved a best overall response of stable disease as per RECIST 1.1. Conclusions: Expanding and increasing the cytotoxicity of NK cells in our heavily pretreated patients has been consistently reliable. SNK01 monotherapy has been very safe and well tolerated in patients with rapidly progressive solid tumors. MTD has not been reached and dose escalation is ongoing. Evaluation of anti-tumor activity is ongoing, but at a minimum, SNK01 appears to slow and possibly halt progression in very aggressive disease and improve quality of life while improving the overall quality of life. The remaining two planned patients are currently being enrolled and a full update will be presented. Clinical trial information: NCT03941262 .

How did partners experience cancer patients' participation in a phase I study? An observational study after a patient's death

2015 ◽  
Vol 14 (3) ◽  
pp. 241-249 ◽  
Author(s):  
Simone M.C.H. Langenberg ◽  
Marlies E.W.J. Peters ◽  
Winette T.A. van der Graaf ◽  
Anke N. Machteld Wymenga ◽  
Judith B. Prins ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psychological Distress ◽  
Observational Study ◽  
Phase I ◽  
Phase I Study ◽  
Complicated Grief ◽  
Well Being ◽  
Negative Consequences ◽  
Phase I Studies

AbstractObjective:It can be assumed that patients' participation in a phase I study will have an important impact on their partners' life. However, evaluation of partners' experiences while patients are undergoing experimental treatment and of their well-being after the patient's death is lacking. We aimed to explore partners' experience of patients' participation in phase I studies and to investigate their well-being after a patient's death.Method:This was an observational study conducted after the patient's death. Partners of deceased patients who had participated in a phase I study completed a questionnaire designed by us for experience evaluation and the Beck Depression Inventory for Primary Care, the Hospital Anxiety and Depression Scale, the Inventory of Traumatic Grief, and the RAND-36 Health Survey.Results:The median age of the 58 participating partners was 58 years (range: 51–65), and 67% was female. Partners reported negative effects on patients' quality of life, but only 5% of partners regretted patients' participation. Approximately two years after the patients' death, 19% of partners scored for depression, 36% for psychological distress, and 46% for complicated grief, and partners generally scored significantly lower on social and mental functioning compared to normative comparators.Significance of Results:Although partners reported negative consequences on patients' quality of life, most did not regret patients' participation in the phase I studies. Prevalence of depression, psychological distress, and complicated grief seemed important problems after a patient's death, and these must be considered when shaping further support for partners of patients participating in phase I trials.

scholarly journals SWE and SMI ultrasound techniques for monitoring needling treatment of ankylosing spondylitis: study protocol for a single-blinded randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mengyu Wang ◽  
Wen Fu ◽  
Lingcui Meng ◽  
Jia Liu ◽  
Lihua Wu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Blood Flow ◽  
Ankylosing Spondylitis ◽  
Outcome Measures ◽  
Healthy Subjects ◽  
Acupuncture Group ◽  
Musculoskeletal Ultrasound ◽  
Sham Control ◽  
Post Intervention

Abstract Background Ankylosing spondylitis (AS) is a high-incidence disease in young men that interferes with patients’ physical and mental wellbeing and overall quality of life (QoL). It is often accompanied by arthralgia, stiffness, and limited lumbar flexibility. Acupuncture is safe and effective for reducing the symptoms of AS, but the underlying mechanisms by which it does so are not fully understood. Therefore, to objectively assess acupuncture efficacy, which is critical for patients making informed decisions about appropriate treatments, we will use shear-wave elastography (SWE) and superb microvascular imaging (SMI) ultrasound techniques to evaluate elasticity of lumbar paraspinal muscles and blood flow to the sacroiliac joint (SIJ) in AS. Methods We will recruit a total of 60 participants diagnosed with AS and 30 healthy subjects. Participants will be randomly allocated 1:1 to either an acupuncture group or a sham control acupuncture group. Primary-outcome measures will be musculoskeletal ultrasound, Ankylosing Spondylitis Quality of Life Scale (ASQoL), Bath Ankylosing Spondylitis Metrology Index (BASMI), and the Visual Analogue Scale (VAS) for pain. Secondary outcome measures will be the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Function Index (BASFI), and Fatigue Scale-14 (FS-14). We will monitor the effect of acupuncture or sham acupuncture on blood flow and SIJ inflammation using SMI, lumbar-muscle stiffness using SWE and the lumbar paraspinal-muscle cross-sectional area (CSA) using a two-dimensional (2D) grayscale imaging. QoL, physical function, and fatigue will be assessed using an evaluation scale or questionnaire developed for this study, with outcomes measured by the ASQoL, BASMI, BASDAI, BASFI, and FS-14. Healthy subjects will not receive acupuncture but undergo only musculoskeletal ultrasound at baseline. Acupuncture and sham control acupuncture interventions will be conducted for 30 min, 2–3 times/week for 12 weeks. Musculoskeletal ultrasound will be conducted at baseline and post-intervention, while other outcomes will be measured at baseline, 6 weeks, and post-intervention. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Discussion The results of this single-blinded, randomized trial with sham controls could help demonstrate the efficacy of acupuncture and clarify whether musculoskeletal ultrasound could be used to evaluate AS. Trial registration ClinicalTrials.gov ChiCTR2000031476. Registered 3 April 2020.

scholarly journals The TELE-DD project on treatment nonadherence in the population with type 2 diabetes and comorbid depression

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Juan Francisco Roy ◽  
María Luisa Lozano del Hoyo ◽  
Fernando Urcola-Pardo ◽  
Alicia Monreal-Bartolomé ◽  
Diana Cecilia Gracia Ruiz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Type 2 Diabetes ◽  
Phase I ◽  
Clinical Depression ◽  
Point Prevalence ◽  
Diabetic Patients ◽  
Comorbid Depression ◽  
Shared Risk

AbstractDiabetic patients have increased depression rates, diminished quality of life, and higher death rates due to depression comorbidity or diabetes complications. Treatment adherence (TA) and the maintenance of an adequate and competent self-care are crucial factors to reach optimal glycaemic control and stable quality of life in these patients. In this report, we present the baseline population analyses in phase I of the TELE-DD project, a three-phased population-based study in 23 Health Centres from the Aragonian Health Service Sector II in Zaragoza, Spain. The objectives of the present report are: (1) to determine the point prevalence of T2D and clinical depression comorbidity and treatment nonadherence; (2) to test if HbA1c and LDL-C, as primary DM outcomes, are related to TA in this population; and (3) to test if these DM primary outcomes are associated with TA independently of shared risk factors for DM and depression, and patients’ health behaviours. A population of 7,271 patients with type-2 diabetes and comorbid clinical depression was investigated for inclusion. Individuals with confirmed diagnoses and drug treatment for both illnesses (n = 3340) were included in the current phase I. A point prevalence of 1.9% was found for the T2D-depression comorbidity. The prevalence of patients nonadherent to treatment for these diseases was 35.4%. Multivariate analyses confirmed that lower diabetes duration, increased yearly PCS visits, HbA1c and LDL-C levels were independently related to treatment nonadherence. These findings informed the development of a telephonic monitoring platform for treatment of nonadherence for people with diabetes and comorbid depression and further trial, cost-effectiveness, and prognostic studies (phases II and III).

A Pilot Study: Application of Hemoglobin and Cortisol Levels, and A Memory Test to Evaluate the Quality of Life of Breast Cancer Patients on Chemotherapy

2013 ◽  
Vol 28 (4) ◽  
pp. 348-356 ◽  
Author(s):  
Wings TY Loo ◽  
Michael CW Yip ◽  
Louis WC Chow ◽  
Qing Liu ◽  
Elizabeth LY Ng ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cancer Patients ◽  
Blood Cells ◽  
Healthy Subjects ◽  
Short Term Memory ◽  
White Blood Cells ◽  
Breast Cancer Patients ◽  
Cortisol Levels

Background Short-term memory (STM) decline in breast cancer patients resulting from chemotherapy was evaluated by means of blood biomarkers, a questionnaire, and a computerized STM test. Methods This study was conducted from January 2013 to June 2013, recruiting 90 subjects: 30 breast cancer patients beginning the 3rd of 4th cycles of docetaxel and cyclophosphamide chemotherapy, 30 recovered patients (who completed 4 cycles of docetaxel for a minimum of 6 months), and 30 healthy subjects (disease-free females). The levels of hemoglobin, red and white blood cells, and cortisol in serum, and a computerized STM test were analyzed to estimate the effects of chemotherapy on STM. A questionnaire was given to all subjects to assess quality of life. Results Statistically significant differences were observed for the blood parameters (hemoglobin, red and white blood cells, and cortisol levels) between healthy and on-treatment subjects (respectively 13.47±0.96 g/dL vs 5.37±0.38 g/dL, 4.58±0.41 1012/L vs 2.07±0.13 1012/L, and 6.15±1.03 109/L vs 0.86±0.41 109/L). Scores of the STM test were significantly lower for patients compared to healthy subjects. As indicated by the results of the questionnaire, breast cancer patients had a higher tendency to forget than healthy controls (X2=3.15; p<0.0001) and recovered subjects (X2=3.15; p<0.0001). Conclusion We found depleted levels of hemoglobin, red and white blood cells as a result of chemotherapy, and elevated levels of stress correlated with poor performances in the computerized STM test. A higher cortisol level might be an important precursor of STM deterioration. Monitoring cortisol would be beneficial for evaluating the quality of life of breast cancer patients on chemotherapy.

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