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Biomedical subjects

C L Loprinzi

Publications and source records attributed to C L Loprinzi.

At least 91 records · Page 5Linked to original sources
PubMed1994

Phase III evaluation of 4 doses of megestrol acetate as therapy for patients with cancer anorexia and/or cachexia.

Several randomized, placebo-controlled clinical trials have demonstrated that megestrol acetate therapy can result in appetite stimulation and nonfluid weight gain in patients with cancer anorexia/cachexia. The present trial was designed to compare megestrol acetate doses ranging from 160 to 1,280 mg/day. day. This trial randomly assigned 342 evaluable patients with cancer anorexia/cachexia to receive oral megestrol acetate at doses of 160, 480, 800 and 1,280 mg/day. Patients were evaluated monthly by history, examination and patient-completed questionnaires, as well as by serum albumin levels. The data demonstrate a positive dose-response effect for megestrol acetate on appetite stimulation (p = 0.02). there was a trend for more nonfluid weight gain with higher drug doses. Megestrol acetate was well tolerated in this group of patients with advanced malignant disease. The positive dose-response effect observed for megestrol acetate on appetite stimulation supports both the prestudy hypothesis and findings in the literature. The optimal dose in this study seemed to be 800 mg/day; no further benefit was derived from using the higher dose. Nonetheless, it may be reasonable to start with lower initial doses in routine clinical practice, taking into account dosage form, availability and cost of therapy.

Administration, Oral↗
PubMed1994

Transdermal clonidine for ameliorating tamoxifen-induced hot flashes.

PURPOSE: To determine the efficacy of transdermal clonidine for alleviating tamoxifen-induced hot flashes in women with a history of breast cancer. PATIENTS AND METHODS: A randomized, double-blind, crossover design was used in this prospective study. Women with a history of breast cancer who were receiving tamoxifen and suffering from hot flashes were potentially eligible for this protocol study. RESULTS: Clonidine did reduce hot-flash frequency to a degree that was statistically impressive (P < .0001), but clinically moderate (20% reduction from baseline). It also decreased hot-flash severity (P = .02, 10% reduction from baseline). Clonidine was related to increased mouth dryness (P < .001), constipation (P < .02), itchiness under the patch (P < .01), and drowsiness (P < .05). CONCLUSION: Better means are needed to alleviate hot flashes among patients in whom estrogen therapy is contraindicated.

Administration, Cutaneous↗
PubMed1994

Randomized trial of a chlorhexidine mouthwash for alleviation of radiation-induced mucositis.

PURPOSE: To determine whether a chlorhexidine mouthwash could alleviate radiation-induced oral mucositis. PATIENTS AND METHODS: Patients scheduled to receive radiation therapy to include greater than one third of the oral cavity mucosa were selected for study. Following stratification, they were randomized in a double-blind manner to receive a chlorhexidine mouthwash or a placebo mouthwash. Both groups were then similarly evaluated for mucositis and mouthwash toxicity. RESULTS: Twenty-five patients were randomized to receive the chlorhexidine mouthwash, while 27 received the placebo mouthwash. Treatment arms were well balanced. There was a trend for more mucositis and there was substantially more toxicity (eg, mouthwash-induced discomfort, taste alteration, and teeth staining) on the chlorhexidine arm. CONCLUSION: In contrast to the prestudy hypothesis that a chlorhexidine mouthwash might provide benefit for patients receiving radiation therapy to the oral mucosa, this study provides strong evidence suggesting that a chlorhexidine mouthwash is detrimental in this clinical situation.

Aged↗
PubMed1994

Regular use of a verbal pain scale improves the understanding of oncology inpatient pain intensity.

PURPOSE: This study was undertaken to determine if the daily use of a verbal pain scale could improve the correlation of pain perception between hospitalized oncology patients and their caregivers. PATIENTS AND METHODS: Hospitalized oncology patients were asked to rate verbally their average pain over the past 24 hours on a scale ranging from 0 to 10. The patients' primary-care physicians and nurses were asked the same question on the same morning after they had evaluated their patients. RESULTS: During a baseline study, only 64% of caregivers' pain scores were within two points of the respective patient's score. Caregivers tended to underestimate patients' pain scores. Caregivers were alerted to these poor results and then requested to ask each patient daily for the average pain score and record this score on the patient's medical record. Nonetheless, correlation between patients' and caregivers' pain scores remained poor (68% within two points of each other) during a second study. The major reason for the poor results appeared to be because caregivers did not routinely ask patients for pain scores. Subsequently, a renewed, more intensive educational effort was undertaken and a third study was conducted. During the third study, 85% of caregivers' and patients' pain scores were within two points of each other (P = .001 when compared with baseline). CONCLUSION: The enforced use of a simple verbal pain assessment tool appears to improve caregiver's understanding of the pain status of hospitalized oncology patients.

Caregivers↗
PubMed1994

Prospective evaluation of prognostic variables from patient-completed questionnaires. North Central Cancer Treatment Group.

PURPOSE: This study was developed to determine whether descriptive information from a patient-completed questionnaire could provide prognostic information that was independent from that already obtained by the patient's physician. PATIENTS AND METHODS: An initial detailed questionnaire was administered to approximately 150 patients with advanced cancer. This questionnaire was subsequently revised and given to a total of 1,115 patients with advanced colorectal or lung cancer. Univariate and multivariate analyses were performed to evaluate the data from these questionnaires. RESULTS: A total of 36 variables showed statistically significant prognostic information for survival in univariate analyses, even though many of these variables were associated with only a minimal increase in risk. A multivariate analysis demonstrated that there was a high correlation between many variables. Three major groups of variables became apparent as providing strong prognostic information. These included the following: (1) a physician's assessment of performance status (PS); (2) a patient's assessment of their own PS; and (3) a nutritional factor such as appetite, caloric intake, or overall food intake. CONCLUSION: Data generated by a patient-completed questionnaire can provide important prognostic information independent from that obtained by other physician-determined prognostic factors.

Analysis of Variance↗
PubMed1994

Randomized placebo-controlled evaluation of hydrazine sulfate in patients with advanced colorectal cancer.

PURPOSE: Hydrazine sulfate is a controversial agent that was originally studied in cancer patients approximately 20 years ago. Based on a series of recent trials that suggested that this drug might have utility in cancer patients, we conducted this study. PATIENTS AND METHODS: Patients with metastatic colorectal cancer were randomized to receive hydrazine sulfate or placebo in a double-blinded manner. Protocol patients did not concurrently receive any other systemic antineoplastic treatment. RESULTS: There were 127 assessable patients entered onto this clinical trial. Data from the study showed trends both for poorer survival and for poorer quality of life (QL) in the hydrazine group. There were no significant differences in the two study arms with regard to anorexia or weight loss. CONCLUSION: This trial failed to demonstrate any benefit for hydrazine sulfate.

Aged↗
PubMed1994

Placebo-controlled trial of hydrazine sulfate in patients with newly diagnosed non-small-cell lung cancer.

PURPOSE: Hydrazine sulfate, an agent that appears to inhibit gluconeogenesis, has been studied in cancer patients for approximately 20 years. There was a recent resurgence of interest in this drug when subset analysis of a small placebo-controlled, double-blind, clinical trial reported improved survival among non-small-cell lung cancer patients with a good performance status who were randomized to receive this drug along with standard chemotherapy. PATIENTS AND METHODS: Patients on this trial had newly diagnosed, unresectable non-small-cell lung cancer and were treated with cisplatin and etoposide. In addition, they were randomized to receive hydrazine sulfate or placebo in a double-blind manner. RESULTS: A total of 243 patients were randomized. Response rates were similar in the two treatment arms. There were trends for worse time to progression and survival in the hydrazine sulfate arm. No significant differences were noted in the two study arms with regard to toxicity or quality of life (QL). CONCLUSION: This trial failed to demonstrate any benefit for patients who received hydrazine sulfate.

Antineoplastic Agents↗
PubMed1994

Do American oncologists know how to use prognostic variables for patients with newly diagnosed primary breast cancer?

PURPOSE: This project was designed to investigate how American medical oncologists actually use prognostic information to treat primary breast cancer patients, and to study their difficulties in combining complex and sometimes contradictory information. METHODS: A simple 2-page questionnaire was faxed in May and June 1993 to a sample of American medical oncologists who were members of the American Society of Clinical Oncology (ASCO). RESULTS: When presented with simple case histories of patients with newly diagnosed invasive breast cancer and asked to assess prognosis on the basis of tumor size, number of involved axillary nodes, patient age, estrogen receptor level, and progesterone receptor level, there was a wide divergence of opinions about the probability of disease-free survival at 10 years (both for cases in which the patient received no adjuvant therapy and for those in which the patient did receive such therapy). The use of additional prognostic data (such as S-phase, tumor histologic and nuclear grading, and cathepsin D status) did not refine the estimates, but led to an equal or greater dispersion of estimates of prognosis. CONCLUSION: There is a clear need for tools to help oncologists integrate prognostic information for primary breast cancer patients. Such tools might lead to greater accuracy and uniformity of prognostic estimates. Such tools might also help make clear what prognostic tests are worth using for routine clinical practice.

Adult↗
PubMed1993

A randomized clinical trial of two different durations of oral cryotherapy for prevention of 5-fluorouracil-related stomatitis.

BACKGROUND: The authors previously reported that 30 minutes of oral cryotherapy inhibits 5-fluorouracil (5-FU)-induced stomatitis. The current trial was designed to determine whether a longer duration of cryotherapy would provide additional protection. METHODS: This trial involved patients who were receiving their first course of a 5-FU plus leucovorin chemotherapy regimen, for which stomatitis is a major dose-limiting toxicity. These patients were randomized to receive either 30 or 60 minutes of oral cryotherapy given at around the same time as the 5-FU therapy. RESULTS: A total of 178 evaluable patients were studied. Both cryotherapy groups had similar degrees of mucositis. CONCLUSION: The authors continue to recommend the use of 30 minutes of oral cryotherapy for patients receiving bolus intensive courses of 5-FU-based chemotherapy.

Adult↗
PubMed1993

Accuracy of fecal occult blood screening for colorectal neoplasia. A prospective study using Hemoccult and HemoQuant tests.

OBJECTIVES: To define the validity of fecal blood as a marker for colorectal neoplasia in the screening setting and to compare yields by Hemoccult and HemoQuant fecal occult blood screening tests. DESIGN: A multicenter masked comparison of fecal blood test results against structural colorectal evaluations and longitudinal follow-up, serving as criterion standards, in nonreferred subjects at risk for colorectal neoplasia. SETTING: Communities, primary care centers, referral centers. PARTICIPANTS: Two groups: (1) 1217 patients aged at least 18 years undergoing routine structural surveillance evaluations following curative resection of a colorectal tumor and (2) 12312 relatives of colorectal cancer patients aged at least 50 years. INTERVENTIONS: Blinded Hemoccult II and HemoQuant testing on three mailed-in stool samples per subject. MAIN OUTCOME MEASURE: Sensitivity of fecal blood tests for colorectal neoplasia. RESULTS: In the postresection group, surveillance evaluations revealed 46 malignant colorectal neoplasms and 402 polyps. At matched specificity, sensitivity of either test for cancer was 26% (95% confidence interval, 13% to 39%). Hemoccult was positive in 21% of intraluminal recurrences, 33% of all new primary tumors, and 29% of Dukes A or B cancers; HemoQuant was elevated in 24%, 28%, and 29%, respectively. Sensitivity for polyps 1.0 cm or larger was 13% by Hemoccult and 11% by HemoQuant. In the group of relatives, estimated sensitivity for cancer at 1 to 3 years of follow-up was 25% to 33% by Hemoccult, not significantly different from the 29% to 43% by HemoQuant. CONCLUSIONS: Based on our observations in the screening setting, fecal blood appears to be a poor marker for colorectal neoplasia. Most cancers and the vast majority of polyps will be missed. Hemoccult and HemoQuant are similarly insensitive.

Adult↗
PubMed1993

Comparative morphine pharmacokinetics following sublingual, intramuscular, and oral administration in patients with cancer.

Previous literature reports have suggested that sublingually administered morphine sulfate results in an improved bioavailability of the drug when compared to orally administered morphine. To investigate this possibility further, we studied six cancer patients all of whom received 10 mg doses of morphine sulfate by intramuscular, oral and sublingual routes. Pharmacokinetic analyses failed to suggest an advantage of sublingual administration when compared with oral dosing. Bioavailability of morphine following intramuscular administration appeared superior to both oral and sublingual routes.

Administration, Oral↗
PubMed1993

A phase II study of 5,6-dihydro-5-azacytidine hydrochloride in disseminated malignant melanoma.

Forty patients with measurable disseminated malignant melanoma and no prior chemotherapy received monthly DHAC, 5 g/m2/24 h, as a continuous infusion. Among 26 "good risk patients" (ECOG performance score 0, 1 and no prior biological therapy), we observed 3 objective regressions. Among 14 "poor-risk patients" (ECOG PS 2 or prior biological therapy), we observed no objective regressions. For all patients, median time to progression and survival were 1 month and 6.7 months, respectively. Transient pleuritic chest pain and mild nausea and vomiting were the most common complications. We were especially impressed with a complete response (CR) for 11+ months in a 43-year-old woman with extensive visceral metastases and another CR lasting > 4.7 months in a 36-year-old woman with nonvisceral metastatic disease. The absence of myelosuppression raises intriguing possibilities for combination regimens including DHAC in the management of malignant melanoma.

Adult↗
PubMed1993

Body-composition changes in patients who gain weight while receiving megestrol acetate.

PURPOSE: Randomized placebo-controlled clinical trials have now established that megestrol acetate causes appetite stimulation and weight gain in patients with anorexia and/or cachexia. There is a paucity of available data to delineate the substance of this increased weight. PATIENTS AND METHODS: Using dual-energy x-ray absorptiometry and tritiated body water methodologies, we performed body-composition measurements in 12 patients with advanced cancer before the institution of oral megestrol acetate (800 mg/d) and at subsequent 2-month intervals. RESULTS: Seven of the 12 patients gained weight (2.1 to 16.5 kg) and had repeat body-composition measurements performed at the time of maximum weight gain. The vast majority of the gained weight was clearly from an increase in adipose tissue, while there was a suggestion that an increase in body fluid was responsible for a minority of the weight gain. CONCLUSION: Megestrol acetate-induced weight gain is primarily the result of an increase in body mass.

Anorexia↗
PubMed1993

Phase III evaluation of four doses of megestrol acetate as therapy for patients with cancer anorexia and/or cachexia.

PURPOSE: Several placebo-controlled randomized clinical trials have demonstrated that megestrol acetate can result in appetite stimulation and nonfluid weight gain in patients with cancer anorexia/cachexia. The present trial was designed to compare megestrol acetate doses ranging from 160 to 1,280 mg/d. METHODS: This trial randomized 342 assessable patients with cancer anorexia/cachexia to receive oral megestrol acetate at doses of 160, 480, 800, or 1,280 mg/d. Patients were evaluated monthly by history, examination, patient-completed questionnaires, and serum albumin levels. RESULTS: The data demonstrate that there is a positive dose-response effect for megestrol acetate on appetite stimulation (P < or = .02). In concert, there was a trend for more nonfluid weight gain with higher drug doses. Megestrol acetate was well tolerated in this group of patients with advanced malignant disease. CONCLUSION: The positive dose-response effect that we observed for megestrol acetate on appetite stimulation supports both our prestudy hypothesis and other available literature. Nonetheless, based primarily on the cost and inconvenience associated with the use of higher doses of this drug, it is reasonable to use 160 mg/d for the initial treatment of cancer anorexia/cachexia in routine clinical practice.

Adult↗
PubMed1993

Postchemotherapy rheumatism.

PURPOSE: This report describes a previously unreported clinical phenomenon that occurs in some patients after completion of combination chemotherapy. METHODS AND RESULTS: Eight case reports are presented. Affected patients developed a syndrome of myalgias/arthralgias within several months of completing cyclophosphamide/fluorouracil (5FU)-containing adjuvant combination chemotherapy for breast cancer. These symptoms did not appear to be related to cancer recurrence or any common rheumatologic disorder. The syndrome generally resolved over several months. CONCLUSION: Postchemotherapy rheumatism is a syndrome of myalgias/arthralgias that usually develops 1 to 3 months after completion of adjuvant chemotherapy. Recognition of this syndrome can limit the need for extensive work-ups to exclude recurrent breast cancer or inflammatory rheumatologic diseases.

Adult↗
PubMed1992

A prospective clinical trial of difluoromethylornithine (DFMO) in patients with resected superficial bladder cancer.

Difluoromethylornithine (DFMO) is a promising chemopreventive agent which is excreted unchanged in the urine, is active in vivo against superficial bladder cancer in animal tumor model systems, and has cytotoxic activity in vitro against superficial bladder cancer cells. Thus, DFMO may be particularly efficacious in preventing the development of bladder tumors and/or for the therapy of established superficial bladder cancer. To examine this hypothesis, an intergroup clinical trial is currently accruing patients with cystoscopically resected superficial bladder cancer (who would otherwise simply be observed). While the primary goal of this protocol is to define a daily dose of DFMO having little or no toxicity for use in future randomized chemoprevention trials, the rate of recurrent bladder tumors will also be followed in the hope that DFMO will inhibit the development of recurrent bladder cancers.

Clinical Trials as Topic↗