The article may be redistributed, reproduced, and reused for non-commercial purposes, provided the original source is properly cited. This article has been cited by other articles in PMC. Abstract The standard treatment for advanced hepatocellular carcinoma HCC is sorafenib, a multikinase inhibitor of tumor cell proliferation and angiogenesis. Hyperthermia inhibits angiogenesis and promotes apoptosis. Potential synergic antiangiogenic and proapoptotic effects represent the rationale for combining sorafenib with electro-hyperthermia EHY in HCC.
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Open in a separate window In , Oberbaum et al. This was one of the first reported randomized controlled trials of a CAM intervention in children with cancer. In , the Committee of the American Institute of Medicine on the use of CAM recommended that the same principles and standards of evidence of treatment effectiveness apply to all treatments, whether currently labeled as conventional medicine or CAM.
We report here on that trial. Patients entered the trial between April and December at 1 out of 28 COG member institutions and at 2 Israeli institutions. Each institution obtained institutional review board approval. Patients receiving a non-myeloablative HSCT, those taking glutamine or vancomycin oral paste, and any individuals allergic or sensitive to Echinacea a component of Traumeel were excluded.
All the patients or their guardians gave signed informed consent. In all, patients were enrolled. Study medication Traumeel S and a placebo identical in appearance and taste were provided free of charge by Heel Baden-Baden, Germany in sterile 2. Traumeel S is manufactured in accordance with the European Union Guidelines on good manufacturing practice for medicinal products.
It was prepared by serial dilution and agitation in saline according to the German Homeopathic Pharmacopoeia. Normal saline was used as placebo. Study design The study was an international multi-center, double-blind, placebo-controlled randomized trial conducted under the auspices of COG. Patients were enrolled in the study once all eligibility requirements had been met and not later than 4 days before transplant.
The study medications were prepared by Heel and were identified by serial number only. The code was kept by the company and the COG statistician only and was not broken until completion of the trial. Treatment began on the day before transplant, so that in all the cases, treatment began before the first symptoms of regimen-induced mucositis appeared.
Treatment ended when patients met the completion criteria see below and not later than the twentieth day after transplant.
A pharmacist drew the contents of the blinded ampoules into an oral syringe. Patients were instructed to rinse the mouth vigorously with the study medication, retain it for thirty seconds and then swallow. This was repeated five times daily.
Patients were instructed not to eat or drink for 30 min after each dose. Patients were permitted any type of analgesic for pain control. Narcotics could be taken orally, i. The type and amount of narcotics were subsequently normalized to morphine equivalents according to a conversion table.
The simpler five-grade World Health Organization oral-toxicity scale 35 was also recorded over the same period. Additionally recorded were: amount of narcotic equivalents used per day, number of days of total parenteral nutrition, number of days of nasogastric feeding, occurrences of adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events v.
Statistical methods The primary outcome for this trial was area-under-the-curve AUC of the Walsh score from the day before transplant to 20 days post transplant. For patients with complete follow-up data, this outcome was simply the sum of the total scores over the 22 days. The mean AUCs in the Traumeel and placebo groups were compared, and the probability of a patient on Traumeel having a lower AUC than a patient on placebo was estimated.
Differences between the groups were tested using the Mann—Whitney test. Missing follow-up data were imputed by linear interpolation when 3 consecutive days or less were missing. Other missing scores were imputed randomly 10 times from scores of similar patients with complete data, and the method of multiple imputation 38 was applied to the 10 full data sets so created.
The treatment groups were compared for balance on potential prognostic factors. Where substantial imbalance was seen, the comparison between the treatment groups was adjusted for the imbalance using a stratified Mann—Whitney test. Maximum treatment duration was 22 days. Another analysis was conducted according to individual patient compliance. The AUCs for Traumeel and placebo were then compared within each of these subgroups and also as a combined group excluding the fourth least compliant subgroup.
The Traumeel and placebo groups were also compared with respect to the World Health Organization score for oral mucositis, using the same approach as for the Walsh score, the amount of narcotics used and days of total parenteral nutrition, using Mann—Whitney tests, the proportions of patients requiring nasogastric feeding, of patients with serious adverse events including veno-occlusive disease and GVHD , and of deaths up to 31 days after termination of protocol therapy, using the Chi-squared test.
Study monitoring was performed after 40, 80 and evaluable patients were entered. Group differences in AUCs for the Walsh score were tested at two-sided significance levels 0.
No significant differences were found on monitoring. The final analysis critical significance level was 0. A flow diagram is presented in Figure 1. Five patients were ineligible to participate, one allocated to Traumeel and four allocated to placebo. Treatment groups were well balanced on all baseline variables except gender Table 2.
CTEP CANCER GOV FORMS CTCAEV3 PDF
Open in a separate window In , Oberbaum et al. This was one of the first reported randomized controlled trials of a CAM intervention in children with cancer. In , the Committee of the American Institute of Medicine on the use of CAM recommended that the same principles and standards of evidence of treatment effectiveness apply to all treatments, whether currently labeled as conventional medicine or CAM. We report here on that trial.
CTEP CANCER GOV FORMS CTCAEV3 EBOOK DOWNLOAD
Felar The price we pay for progress: Publications were limited to trials exploring pharmacologic interventions in patients with solid tumors. December 24, File ctep cancer gov forms ctcaev3 Discussion A careful balance between efficacy ctep cancer gov forms ctcaev3 toxicity is of primary importance in medical interventions. Canncer symptoms Cardiac general Metabolic Hemorrhage. Statistical analysis Results of the ctep cancer gov forms ctcaev3 were summarized by cahcer statistics. Open in a separate window. Forrms discrepancy was resolved by consensus among all authors of this study.