American journal of clinical oncology
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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. · Jun 1990
ReviewInitial results of phase I/II interstitial thermoradiotherapy for primary advanced and local recurrent tumors.
Since January 1986 in a phase I/II study, 45 lesions (30 head and neck, 11 pelvic, and 4 other lesions) in 44 patients (24 men, 20 women; age 18-81 years) received a combination of interstitial Ir-192 radiotherapy (IRT) and interstitial 915 MHz MW hyperthermia (IHT) supplemented by external radiation (ERT). In June 1989, evaluation was performed for lesions with minimum follow-up (FU) of 6 months and FU periods between 6 and 39 months (mean: 16 months, SD +/- 9). The tumors comprised 21 advanced primary (AP) lesions without prior ERT, 18 local recurrent (LR) and 6 local metastatic (LM) lesions with variable prior treatment modes; 24 lesions had received prior ERT between 40 and 70 Gy, 23 chemotherapy and 30 prior surgery. ⋯ Six patients died prior to 12 months FU, three with LC and three with progressive disease. So far 10 (22%) patients have developed distant metastases. Acute side-effects occurred in 15 lesions (33%) resulting in 12 (27%) long-term complications with 3 lesions (7%) requiring surgery.(ABSTRACT TRUNCATED AT 400 WORDS)