American journal of clinical oncology
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Am. J. Clin. Oncol. · Aug 1993
Randomized Controlled Trial Clinical TrialAn analysis of radiotherapy data from the CNS cancer consortium's randomized prospective trial comparing AZQ to BCNU in the treatment of patients with primary malignant brain tumors. The CNS cancer consortium.
The CNS Cancer Consortium has conducted a phase III study comparing diaziquone (AZQ) with carmustine (BCNU) in the treatment of adults with primary anaplastic glial brain tumors. Patients eligible for this study were 18 years of age or older at the time of biopsy, subtotal resection, or gross total resection of an anaplastic glial brain tumor. Within 3 weeks of surgery, patients received whole brain radiotherapy at 1.7 to 2 Gy per fraction to a total whole brain dose of 42-48 Gy. ⋯ Two-year Kaplan-Meier survival was 22% in the AZQ-treated patients and 25% in BCNU-treated patients. In an analysis of radiotherapy administered we found that, within the range of doses required for this study, there was no influence of whole brain dose, boost dose, total dose, or size of the boost field on survival. The institution providing radiotherapy (teaching hospital vs nonteaching facility) did not influence survival.
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Am. J. Clin. Oncol. · Apr 1993
Randomized Controlled Trial Clinical TrialRandomized comparison of the antiemetic efficacy of a serotonin type 3 receptor antagonist (MDL 72,222) with a high-dose metoclopramide regimen.
This pilot randomized study compared MDL 72,222, a highly selective 5-HT3 receptor antagonist, with a high-dose metoclopramide regimen (HDM) for chemotherapy-induced nausea and vomiting. MDL 72,222 was given in 20 mg intravenous doses 30 minutes before chemotherapy, as well as 2, 6, and 12 hours after chemotherapy infusion. The HDM was composed of diphenhydramine 50 mg i.v., metoclopramide 2 mg/kg i.v., and lorazepam 0.04 mg/kg i.v. administered 30 minutes before chemotherapy and 2, 4, 6, and 8 hours after chemotherapy. ⋯ The median number of emetic episodes in the first 24 hours was 0.5 for MDL 72,222 and 1.0 for HDM patients. HDM patients were frequently asleep and were not awakened for evaluation of nausea with the VAS; 58% (70 of 120) of the HDM (mean score: 19.1 mm) and 14% (17 of 119) of the MDL 72,222 (mean score: 17.1) patients could not have VAS scores obtained (X2 = 50.74, p < 0.001). MDL 72,222 had similar efficacy with less sedation, and further trials are warranted.
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Am. J. Clin. Oncol. · Oct 1992
Randomized Controlled Trial Clinical TrialUsefulness of megestrol acetate in cancer cachexia and anorexia. A placebo-controlled study.
To assess the effect of megestrol acetate (MA) on the appetite and weight of cancer patients with nonhormone-dependent tumors, a double-blind, placebo-controlled trial was designed. One hundred fifty patients were included: 76 were given MA (240 mg/day orally) for at least 2 months, and 74 were given placebo (P). Body weight, subjective sense of appetite (SSA) evaluated by an analogic linear visual scale scored from 1 to 10, and performance status (PS) were measured before therapy and monthly thereafter. ⋯ There was no significant difference in PS for the treatment groups before or after therapy. The percentage of reported adverse events did not differ significantly from one treatment group to the next. We conclude that therapy with MA at a dose of 240 mg/day improved SSA and was associated with moderate weight gain in patients with hormone-insensitive malignancies.
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Am. J. Clin. Oncol. · Jun 1992
Randomized Controlled Trial Comparative Study Clinical TrialA controlled study of sustained-release morphine sulfate tablets in chronic pain from advanced cancer.
The purpose of this double-blind crossover study was to determine whether a sustained-release morphine sulfate (SRMS) tablet given orally every 12 hours could adequately replace immediate-release morphine sulfate solution (IRMS) given orally every 4 hours in hospitalized patients with chronic pain from advanced cancer. Of 33 patients entered, 27 completed the study and were included in the efficacy and safety analysis. Patients were initially randomized to receive either 30-mg SRMS tablets every 12 hours or IRMS at the same mg/24 hours dose, every 4 hours. ⋯ The incidence of breakthrough pain was similar for both treatment groups, as was the incidence of confusion and constipation. The results demonstrated that SRMS is a safe, effective analgesic preparation for patients who require oral opioids for cancer pain. The data also support the conclusion that sustained-release morphine tablets administered every 12 hours can replace an immediate-release morphine solution administered every 4 hours.
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Am. J. Clin. Oncol. · Apr 1986
Randomized Controlled Trial Clinical TrialBenzydamine HCl, a new agent for the treatment of radiation mucositis of the oropharynx.
Benzydamine HCl is a new nonsteroidal analgesic and anti-inflammatory compound which is not chemically related to local anesthetics such as procaine and xylocaine. A double-blind, randomized clinical investigation was carried out to determine the analgesic and anti-inflammatory effectiveness of benzydamine HCl in patients with radiation-induced mucositis of the oropharynx. Of the 67 patients in the study, 37 were on benzydamine and 30 on placebo. ⋯ There was also significant improvement in terms of reduction in hyperemia and mucositis in benzydamine group. No systemic side effects associated with benzydamine medication were noted. In view of the relative ineffectiveness of systemic analgesics and topical anesthetics for these conditions, benzydamine HCl promises to be a useful addition to the therapeutic armamentarium.