Evaluation of the Use of the Tissue Genesis® Icellator Cell Isolation System® ("Icellator") Autologous Adipose Stromal Vascular Fraction Cells as a Treatment for Post-Irradiated Induced Xerostomia in Head and Neck Cancer Patients

Prospective, single center, double armed, randomized treatment with observation only (standard of care) control group. Subjects receiving study treatment will have 6 months of study follow-up. Stromal vascular fraction (SVF), an adipose-derived tissue preparation, will be injected into salivary glands to determine safety and efficacy to restore saliva production in head and neck cancer patients with chronic xerostomia resulting from radiation therapy.

开始日期2018-11-01

申办/合作机构

Midwestern Regional Medical Center, Inc.

NCT02521077 / Withdrawn临床2期IIT

Prospective Double Blind Study of the Effect of Intravenous High Dose Ascorbic Acid in Women Receiving Adjuvant or Neo-Adjuvant Chemotherapy for Early Stage Breast Cancer

This is a parallel-track, randomized study will observe whether intravenous ascorbic acid reduces the reported fatigue in women receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer.

开始日期2017-05-01

申办/合作机构

Midwestern Regional Medical Center, Inc.

NCT02952742 / Withdrawn临床2期IIT

Black Cohosh (Actaea Racemosa) for Hot Flashes in Prostate Cancer Patients on Androgen Deprivation Therapy: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

This is a randomized, placebo-controlled crossover study. Participants will be actively participating in the study for 6 months, and enrolled in the study for up to 1 year. During the first phase of the study, the participants will be randomized into either the placebo group or treatment group for 8 weeks following 1 week of baseline data collection (no treatment). Following this first phase, a no-treatment washout period of at least 3 weeks will be implemented for all participants. After the washout period, the randomized groups will switch from treatment to placebo group, or placebo to treatment group for an additional 8 week period. Hot flash frequency and severity will be documented using a daily hot flash diary and calculated using the Hot Flash Score questionnaire. The impact on quality of life will be documented by weekly Hot Flash Related Daily Interference Scale (HFRDIS) questionnaires.

开始日期2016-11-01

申办/合作机构

Midwestern Regional Medical Center, Inc.

100 项与 Midwestern Regional Medical Center, Inc. 相关的临床结果

登录后查看更多信息

0 项与 Midwestern Regional Medical Center, Inc. 相关的专利（医药）

登录后查看更多信息

项与 Midwestern Regional Medical Center, Inc. 相关的文献（医药）

2018-09-15·January 2018

Low Volume Neurolytic Retrocrural Celiac Plexus Block for Visceral Cancer Pain: Retrospective Review of 507 Patients with Severe Malignancy Related Pain Due to Primary Abdominal Cancer or Metastatic Disease

作者: Sam Li ; Abed Rahman ; Raed Rahman ; George Macrinici

Background: Abdominal pain from primary cancer or metastatic disease is a significant cause of pain for patients undergoing treatment for the disease. Patient’s pain may be resistant to conventional analgesics. The need for timely pain relief in order to facilitate further care in the cancer treatment plan should be a priority. Objectives: The aim of this retrospective observational review was to assess the relief given with a low volume neurolytic retrocrural celiac plexus nerve block, the duration of the procedure, the duration of relief, the reduction in daily opioid consumption, and the improvement of quality of life in a patient suffering from incapacitating abdominal pain due to primary abdominal malignancy or abdominal metastatic disease. Patients were given a neurolytic celiac plexus block without previous diagnostic block due to multiple comorbidities. Study Design: This is a retrospective, observational study. Methods: Five hundred and seven patients were studied and data at 5 months for 455 patients were retained at the end of the review. They were evaluated in the pain center prior to and after the neurolytic retrocrural celiac plexus nerve block under fluoroscopic guidance. They were assessed on duration of procedure, pain scores (numeric rating scale 0-10), daily opioid consumption, quality of life improvement (simple yes or no question at 3 months) and routine follow-up during treatment for the cancer for 6 months or end of life. All data was gathered by extensive chart review and placed on a spreadsheet for analysis. Results: Follow-up was completed 6 months after the procedure. Pain scores, daily opioid consumption, and quality of life showed improvement for the duration of the study. There was some return in pain during the fourth to sixth month due to disease progression and the anticipated duration of the neurolytic agent. Some short duration known side effects did occur. An initial vascular contrast uptake of 6.7% was noted during the procedure while utilizing digital subtraction angiography with fluoroscopy. Limitations: A larger sample size would be ideal, as well as, a prospective trial with a control group, but this is unrealistic in our patient population. A proven quality of life questionnaire would be beneficial. Comparing alcohol, phenol and radiofrequency thermocoagulation would be interesting to equate duration, effect, and side effects. Conclusion: Low volume neurolytic retrocrural celiac plexus nerve block with phenol is a safe procedure providing up to 6 months of pain relief and is an effective, well-established, minimally time-consuming procedure for abdominal pain due to primary malignancy or metastatic spread. Key words: Celiac plexus, neurolytic, abdominal cancer pain, pain, retrocrural, cancer pain

2018-09-01·Pain physician3区 · 医学

3区 · 医学

Article

作者: Li, Sam ; Macrinici, George ; Rahman, Abed ; Rahman, Raed

BACKGROUNDAbdominal pain from primary cancer or metastatic disease is a significant cause of pain for patients undergoing treatment for the disease. Patient's pain may be resistant to conventional analgesics. The need for timely pain relief in order to facilitate further care in the cancer treatment plan should be a priority.OBJECTIVESThe aim of this retrospective observational review was to assess the relief given with a low volume neurolytic retrocrural celiac plexus nerve block, the duration of the procedure, the duration of relief, the reduction in daily opioid consumption, and the improvement of quality of life in a patient suffering from incapacitating abdominal pain due to primary abdominal malignancy or abdominal metastatic disease. Patients were given a neurolytic celiac plexus block without previous diagnostic block due to multiple comorbidities.STUDY DESIGNThis is a retrospective, observational study.METHODSFive hundred and seven patients were studied and data at 5 months for 455 patients were retained at the end of the review. They were evaluated in the pain center prior to and after the neurolytic retrocrural celiac plexus nerve block under fluoroscopic guidance. They were assessed on duration of procedure, pain scores (numeric rating scale 0-10), daily opioid consumption, quality of life improvement (simple yes or no question at 3 months) and routine follow-up during treatment for the cancer for 6 months or end of life. All data was gathered by extensive chart review and placed on a spreadsheet for analysis.RESULTSFollow-up was completed 6 months after the procedure. Pain scores, daily opioid consumption, and quality of life showed improvement for the duration of the study. There was some return in pain during the fourth to sixth month due to disease progression and the anticipated duration of the neurolytic agent. Some short duration known side effects did occur. An initial vascular contrast uptake of 6.7% was noted during the procedure while utilizing digital subtraction angiography with fluoroscopy.LIMITATIONSA larger sample size would be ideal, as well as, a prospective trial with a control group, but this is unrealistic in our patient population. A proven quality of life questionnaire would be beneficial. Comparing alcohol, phenol and radiofrequency thermocoagulation would be interesting to equate duration, effect, and side effects.CONCLUSIONLow volume neurolytic retrocrural celiac plexus nerve block with phenol is a safe procedure providing up to 6 months of pain relief and is an effective, well-established, minimally time-consuming procedure for abdominal pain due to primary malignancy or metastatic spread.KEY WORDSCeliac plexus, neurolytic, abdominal cancer pain, pain, retrocrural, cancer pain.

2018-01-01·Annals of Oncology1区 · 医学

Veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in patients with BRCA1/2 locally recurrent/metastatic breast cancer: randomized phase II study

1区 · 医学

Article

作者: Kaufman, B ; Nickner, C ; Gradishar, W ; Qian, J ; Bondarenko, I ; Jakobsen, E H ; Shparyk, Y ; Friedlander, M ; Ratajczak, C K ; Robson, M ; Palácová, M ; Citrin, D ; Puhalla, S ; Jager, A ; Garber, J E ; Qin, Q ; Telli, M L ; Domchek, S M ; Isakoff, S J ; Marcom, P K ; Campone, M ; Kaklamani, V ; Shepherd, S P ; Han, H S ; Chmielowska, E ; Diéras, V

BackgroundHomologous recombination defects in BRCA1/2-mutated tumors result in sensitivity to poly(ADP-ribose) polymerase inhibitors, which interfere with DNA damage repair. Veliparib, a potent poly(ADP-ribose) polymerase inhibitor, enhanced the antitumor activity of platinum agents and temozolomide in early phase clinical trials. This phase II study examined the safety and efficacy of intermittent veliparib with carboplatin/paclitaxel (VCP) or temozolomide (VT) in patients with BRCA1/2-mutated breast cancer.Patients and methodsEligible patients ≥18 years with locally recurrent or metastatic breast cancer and a deleterious BRCA1/2 germline mutation were randomized 1 : 1 : 1 to VCP, VT, or placebo plus carboplatin/paclitaxel (PCP). Primary end point was progression-free survival (PFS); secondary end points included overall survival (OS) and overall response rate (ORR).ResultsOf 290 randomized patients, 284 were BRCA+, confirmed by central laboratory. For VCP versus PCP, median PFS was 14.1 and 12.3 months, respectively [hazard ratio (HR) 0.789; 95% CI 0.536-1.162; P = 0.227], interim median OS 28.3 and 25.9 months (HR 0.750; 95% CI 0.503-1.117; P = 0.156), and ORR 77.8% and 61.3% (P = 0.027). For VT (versus PCP), median PFS was 7.4 months (HR 1.858; 95% CI 1.278-2.702; P = 0.001), interim median OS 19.1 months (HR 1.483; 95% CI 1.032-2.131; P = 0.032), and ORR 28.6% (P < 0.001). Safety profile was comparable between carboplatin/paclitaxel arms. Adverse events (all grades) of neutropenia, anemia, alopecia, and neuropathy were less frequent with VT versus PCP.ConclusionNumerical but not statistically significant increases in both PFS and OS were observed in patients with BRCA1/2-mutated recurrent/metastatic breast cancer receiving VCP compared with PCP. The addition of veliparib to carboplatin/paclitaxel significantly improved ORR. There was no clinically meaningful increase in toxicity with VCP versus PCP. VT was inferior to PCP. An ongoing phase III trial is evaluating VCP versus PCP, with optional continuation single-agent therapy with veliparib/placebo if chemotherapy is discontinued without progression, in this patient population.Clinical trial informationNCT01506609.

100 项与 Midwestern Regional Medical Center, Inc. 相关的药物交易

登录后查看更多信息

100 项与 Midwestern Regional Medical Center, Inc. 相关的转化医学

登录后查看更多信息