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Systematic Review of Intravenous Ascorbate in Cancer Clinical Trials.

ABSTRACT: BACKGROUND:Ascorbate (vitamin C) has been evaluated as a potential treatment for cancer as an independent agent and in combination with standard chemotherapies. This review assesses the evidence for safety and clinical effectiveness of intravenous (IV) ascorbate in treating various types of cancer. METHODS:Single arm and randomized Phase I/II trials were included in this review. The PubMed, MEDLINE, and Cochrane databases were searched. Results were screened by three of the authors (GN, RP, and CJP) to determine if they met inclusion criteria, and then summarized using a narrative approach. RESULTS:A total of 23 trials involving 385 patients met the inclusion criteria. Only one trial, in ovarian cancer, randomized patients to receive vitamin C or standard of care (chemotherapy). That trial reported an 8.75 month increase in progression-free survival (PFS) and an improved trend in overall survival (OS) in the vitamin C treated arm. CONCLUSION:Overall, vitamin C has been shown to be safe in nearly all patient populations, alone and in combination with chemotherapies. The promising results support the need for randomized placebo-controlled trials such as the ongoing placebo-controlled trials of vitamin C and chemotherapy in prostate cancer.

SUBMITTER: Nauman G

PROVIDER: S-EPMC6071214 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Systematic Review of Intravenous Ascorbate in Cancer Clinical Trials.

Nauman Gina G Gray Javaughn Corey JC Parkinson Rose R Levine Mark M Paller Channing J CJ

Antioxidants (Basel, Switzerland) 20180712 7

<h4>Background</h4>Ascorbate (vitamin C) has been evaluated as a potential treatment for cancer as an independent agent and in combination with standard chemotherapies. This review assesses the evidence for safety and clinical effectiveness of intravenous (IV) ascorbate in treating various types of cancer.<h4>Methods</h4>Single arm and randomized Phase I/II trials were included in this review. The PubMed, MEDLINE, and Cochrane databases were searched. Results were screened by three of the author ...[more]

PMID: 30002308

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Project description:The potential of gossypol and of its R-(-)-enantiomer (R-(-)-gossypol acetic acid, AT-101), has been evaluated for treatment of cancer as an independent agent and in combination with standard chemo-radiation-therapies, respectively. This review assesses the evidence for safety and clinical effectiveness of oral gossypol/AT-101 in treating various types of cancer. The databases PubMed, MEDLINE, Cochrane, and ClinicalTrials.gov were examined. Phase I and II trials as well as single arm and randomized trials were included in this review. Results were screened to determine if they met inclusion criteria and then summarized using a narrative approach. A total of 17 trials involving 759 patients met the inclusion criteria. Overall, orally applied gossypol/AT-101 at low doses (30 mg daily or lower) was determined as well tolerable either as monotherapy or in combination with chemo-radiation. Adverse events should be strictly monitored and were successfully managed by dose-reduction or treating symptoms. There are four randomized trials, two performed in patients with advanced non-small cell lung cancer, one in subjects with head and neck cancer, and one in patients with metastatic castration-resistant prostate cancer. Thereby, standard chemotherapy (either docetaxel (two trials) or docetaxel plus cisplatin or docetaxel plus prednisone) was tested with and without AT-101. Within these trials, a potential benefit was observed in high-risk patients or in some patients with prolongation in progression-free survival or in overall survival. Strikingly, the most recent clinical trial combined low dose AT-101 with docetaxel, fluorouracil, and radiation, achieving complete responses in 11 of 13 patients with gastroesophageal carcinoma (median duration of 12 months) and a median progression-free survival of 52 months. The promising results shown in subsets of patients supports the need of further specification of AT-101 sensitive cancers as well as for the establishment of effective AT-101-based therapy. In addition, the lowest recommended dose of gossypol and its precise toxicity profile need to be confirmed in further studies. Randomized placebo-controlled trials should be performed to validate these data in large cohorts.

Project description:BackgroundExternal cephalic version (ECV) is a frequently performed obstetric procedure for fetal breech presentation to avoid cesarean delivery. Neuraxial, intravenous, and inhalational anesthetic techniques have been studied to reduce maternal discomfort caused by the forceful manipulation. This study compares the effects of these anesthetic techniques on ECV and incidence of cesarean delivery.MethodsWe conducted a comprehensive literature search for published randomized controlled trials (RCTs) or well-conducted quasi-randomized trials of ECV performed either without anesthesia or under neuraxial, intravenous, or inhalational anesthesia. Pairwise random-effects meta-analyses and network meta-analyses were performed to compare and rank the perinatal outcomes of the 3 anesthetic interventions and no anesthesia control, including the rate of successful version, cesarean delivery, maternal hypotension, nonreassuring fetal response, and adequacy of maternal pain control/satisfaction.ResultsEighteen RCTs and 1 quasi-randomized trial involving a total of 2296 term parturients with a noncephalic presenting singleton fetus were included. ECV under neuraxial anesthesia had significantly higher odds of successful fetal version compared to control (odds ratio [OR] = 2.59; 95% confidence interval [CI], 1.88-3.57), compared to intravenous anesthesia (OR = 2.08; 95% CI, 1.36-3.16), and compared to inhalational anesthesia (OR = 2.30; 95% CI, 1.33-4.00). No association was found between anesthesia interventions and rate of cesarean delivery. Neuraxial anesthesia was associated with higher odds of maternal hypotension (OR = 9.33; 95% CI, 3.14-27.68). Intravenous anesthesia was associated with significantly lower odds of nonreassuring fetal response compared to control (OR = 0.36; 95% CI, 0.16-0.82). Patients received neuraxial anesthesia reported significantly lower visual analog scale (VAS) of procedure-related pain (standardized mean difference [SMD] = -1.61; 95% CI, -1.92 to -1.31). The VAS scores of pain were also significantly lower with intravenous (SMD = -1.61; 95% CI, -1.92 to -1.31) and inhalational (SMD = -1.19; 95% CI, -1.58 to -0.8) anesthesia. The VAS of patient satisfaction was significantly higher with intravenous anesthesia (SMD = 1.53; 95% CI, 0.64-2.43).ConclusionsCompared to control, ECV with neuraxial anesthesia had a significantly higher successful rate; however, the odds of maternal hypotension increased significantly. All anesthesia interventions provided significant reduction of procedure-related pain. Intravenous anesthesia had significantly higher score in patient satisfaction and lower odds of nonreassuring fetal response. No evidence indicated that anesthesia interventions were associated with significant decrease in the incidence of cesarean delivery compared to control.

Project description:BackgroundInterest in the use of wearables in medical care is increasing. Wearables can be used to monitor different variables, such as vital signs and physical activity. A crucial point for using wearables in oncology is if patients already under the burden of severe disease and oncological treatment can accept and adhere to the device. At present, there are no specific recommendations for the use of wearables in oncology, and little research has examined the purpose of using wearables in oncology.ObjectiveThe purpose of this review is to explore the use of wearables in clinical trials during cancer treatment, with a special focus on adherence.MethodsPubMed and EMBASE databases were searched prior and up to October 3, 2019, with no limitation in the date of publication. The search strategy was aimed at studies using wearables for monitoring adult patients with cancer during active antineoplastic treatment. Studies were screened independently by 2 reviewers by title and abstract, selected for inclusion and exclusion, and the full-text was assessed for eligibility. Data on study design, type of wearable used, primary outcome, adherence, and device outcome were extracted. Results were presented descriptively.ResultsOur systematic search identified 1269 studies, of which 25 studies met our inclusion criteria. The types of cancer represented in the studies were breast (7/25), gastrointestinal (4/25), lung (4/25), and gynecologic (1/25); 9 studies had multiple types of cancer. Oncologic treatment was primarily chemotherapy (17/25). The study-type distribution was pilot/feasibility study (12/25), observational study (10/25), and randomized controlled trial (3/25). The median sample size was 40 patients (range 7-180). All studies used a wearable with an accelerometer. Adherence varied across studies, from 60%-100% for patients wearing the wearable/evaluable sensor data and 45%-94% for evaluable days, but was differently measured and reported. Of the 25 studies, the most frequent duration for planned monitoring with a wearable was 8-30 days (13/25). Topics for wearable outcomes were physical activity (19/25), circadian rhythm (8/25), sleep (6/25), and skin temperature (1/25). Patient-reported outcomes (PRO) were used in 17 studies; of the 17 PRO studies, only 9 studies reported correlations between the wearable outcome and the PRO.ConclusionsWe found that definitions of outcome measures and adherence varied across studies, and limited consensus among studies existed on which variables to monitor during treatment. Less heterogeneity, better consensus in terms of the use of wearables, and established standards for the definitions of wearable outcomes and adherence would improve comparisons of outcomes from studies using wearables. Adherence, and the definition of such, seems crucial to conclude on data from wearable studies in oncology. Additionally, research using advanced wearable devices and active use of the data are encouraged to further explore the potential of wearables in oncology during treatment. Particularly, randomized clinical studies are warranted to create consensus on when and how to implement in oncological practice.

Project description:IntroductionOptimal pain management is crucial to the postoperative recovery process. We aimed to evaluate the efficacy and safety of intravenous oxycodone with intravenous fentanyl, morphine, sufentanil, pethidine, and hydromorphone for acute postoperative pain.MethodsA systematic literature search of PubMed, Cochrane Library, and EMBASE databases was performed for randomized controlled trials published from 2008 through 2017 (inclusive) that evaluated the acute postoperative analgesic efficacy of intravenous oxycodone against fentanyl, morphine, sufentanil, pethidine, and hydromorphone in adult patients (age ≥ 18 years). Outcomes examined included analgesic consumption, pain intensity levels, side effects, and patient satisfaction.ResultsEleven studies were included in the review; six compared oxycodone with fentanyl, two compared oxycodone with morphine, and three compared oxycodone with sufentanil. There were no eligible studies comparing oxycodone with pethidine or hydromorphone. Overall, analgesic consumption was lower with oxycodone than with fentanyl or sufentanil. Oxycodone exhibited better analgesic efficacy than fentanyl and sufentanil, and comparable analgesic efficacy to morphine. In terms of safety, there was a tendency towards more side effects with oxycodone than with fentanyl, but the incidence of side effects with oxycodone was comparable to morphine and sufentanil. Where patient satisfaction was evaluated, higher satisfaction levels were observed with oxycodone than with sufentanil and comparable satisfaction was noted when comparing oxycodone with fentanyl. Patient satisfaction was not evaluated in the studies comparing oxycodone with morphine.ConclusionsOur findings suggest that intravenous oxycodone provides better analgesic efficacy than fentanyl and sufentanil, and comparable efficacy to morphine with less adverse events such as sedation. No studies comparing intravenous oxycodone with pethidine or hydromorphone were identified in this review. Better alignment of study methodologies for future research in this area is recommended to provide the best evidence base for a meta-analysis.FundingMundipharma Singapore Holding Pte Ltd, Singapore.

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Systematic Review of Intravenous Ascorbate in Cancer Clinical Trials.

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Systematic Review of Intravenous Ascorbate in Cancer Clinical Trials.

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