Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0027497 (nausea)
 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Preliminary information has suggested that megestrol acetate leads to appetite stimulation and nonfluid weight gain in patients with breast cancer, other cancers, and AIDS. Pursuant to this, we developed a randomized, double-blind, placebo-controlled trial of megestrol acetate in patients with cancer-associated anorexia and cachexia. We randomly assigned 133 eligible patients to receive 800 mg of megestrol acetate per day or a placebo. Patients assigned to megestrol acetate more frequently reported improved appetite (P = .003) and food intake (P = .009) when compared with patients receiving the placebo. A weight gain of 15 lb or more over baseline was seen in 11 of 67 (16%) patients receiving megestrol acetate compared with one of 66 (2%) given the placebo (P = .003). Patients receiving megestrol acetate reported significantly less nausea (13% vs. 38%; P = .001) and emesis (8% vs. 25%, P = .009). No clinically or statistically significant toxic reactions were ascribed to megestrol acetate, with the exception of mild edema. This study convincingly demonstrated that megestrol acetate can stimulate appetite and food intake in patients with anorexia and cachexia associated with cancer, leading to significant weight gain in a proportion of such patients.
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PMID:Controlled trial of megestrol acetate for the treatment of cancer anorexia and cachexia. 199 53

We performed phase I study of FK 435, a new antiestrogen, in 30 patients with advanced breast cancer. Slight to moderate adverse reactions were noted as follows. Single-dose study: anorexia, nausea, lassitude in one patient (80 mg), decreased serum calcium in one (160 mg), redness, tenderness in one, facial flushing, hot flushes, headache in one (320 mg). Repeated-dose study: anorexia, nausea in one patient (40 mg/day), anorexia, diarrhea, increased FSH in one, increased PRL in one (80 mg/day). FK 435 was well tolerated. Tmax was 3-5 hours, T1/2 about 25 hours. Most of FK 435 was excreted into urine as glucuronide.
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PMID:[Phase I study of FK 435]. 219 79

The National Surgical Adjuvant Breast and Bowel Project (NSABP) implemented protocol B-15 to compare 2 months of Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH) and cyclophosphamide (AC) with 6 months of conventional cyclophosphamide, methotrexate, and fluorouracil (CMF) in patients with breast cancer nonresponsive to tamoxifen (TAM, T). A second aim was to determine whether AC followed in 6 months by intravenous (IV) CMF was more effective than AC without reinduction therapy. Through 3 years of follow-up, findings from 2,194 patients indicate no significant difference in disease-free survival (DFS, P = .5), distant disease-free survival (DDFS, P = .5) or survival (S, P = .8) among the three groups. Since the outcome from AC and CMF was almost identical, the issue arises concerning which regimen is more appropriate for the treatment of breast cancer patients. AC seems preferable since, following total mastectomy, AC was completed on day 63 versus day 154 for conventional CMF; patients visited health professionals three times as often for conventional CMF as for AC; women on AC received therapy on each of 4 days versus on each of 84 days for conventional CMF; and nausea-control medication was given for about 84 days to conventional CMF patients versus for about 12 days to patients on AC. The difference in the amount of alopecia between the two treatment groups was less than anticipated. While alopecia was almost universally observed following AC therapy, 71% of the CMF patients also had hair loss and, in 41%, the loss was greater than 50%. This study and NSABP B-16, which evaluates the worth of AC therapy in TAM-responsive patients, indicate the merit of 2 months of AC therapy for all positive-node breast cancer patients.
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PMID:Two months of doxorubicin-cyclophosphamide with and without interval reinduction therapy compared with 6 months of cyclophosphamide, methotrexate, and fluorouracil in positive-node breast cancer patients with tamoxifen-nonresponsive tumors: results from the National Surgical Adjuvant Breast and Bowel Project B-15. 220 91

The treatment for women diagnosed with early breast cancer is complex, dynamic, and controversial. More choices are available for local control and indications for systemic adjuvant therapy have changed dramatically. Knowledge of predictable physical and psychological responses through the various phases of primary treatment is the first critical element for the rehabilitation of these oncology patients. The health care provider can then anticipate problems, prepare the patient with accurate information, and institute interventions early to minimize symptoms. Information and psychological needs dominate the diagnostic phase, during which communication and emotional support are of paramount importance for decision making. Psychological distress persists through the treatment phase regardless of the choice of mastectomy or breast conservation surgery with radiation. The physical symptoms of these choices are similar, primarily related to the axillary lymph node dissection. Fatigue, breast soreness, sensation, and skin changes are common symptoms with breast irradiation that resolve over time. Nausea, vomiting, fatigue, hair loss, menopausal symptoms, and weight gain are predictable chemotherapy-related side effects and are reported as mild to moderately distressful by the majority of patients. Consistency of information, support, collaboration, coordination of care, and communication among patients and health care providers are essential to meet the challenge of successful treatment and rehabilitation.
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PMID:Symptoms and rehabilitation needs of patients with early stage breast cancer during primary therapy. 220 70

Patient resources for coping with breast cancer can be enhanced by attention to cognitive, affective, psychosomatic, and social components of the illness. The diagnosis and treatment of breast cancer constitutes an immediate confrontation with mortality, and sympathetic but direct examination of the patient's vulnerability and means of coping with it will reduce rather than amplify death anxiety. The development and pursuit of realistic goals influenced by the prognosis can help patients adjust constructively. Extremes of emotion are to be expected at times, but persistent depression and/or anxiety should be vigorously treated, including the use of appropriate psychoactive medication when the symptoms are primarily somatic (e.g., sleep disturbance and reductions in energy). Physical symptoms such as pain, nausea, and vomiting can be controlled by teaching patients such techniques as self-hypnosis, biofeedback, and systemic desensitization. Finally, a feeling of social isolation is the rule, not the exception, with cancer patients. Group and family treatment can effectively counter this. Systematic studies of such treatment interventions have shown favorable results, including significant reductions in mood disturbance and pain.
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PMID:Facilitating emotional coping during treatment. 220 73

The aim of the present study is to confirm the antitumor activity of orally administered idarubicin (IDA) in patients with advanced breast cancer. Doxorubicin (ADRIA) was chosen as control treatment and the patients were randomized to receive either IDA or ADRIA according to a 2:1 ratio. Sixty-three patients, 77% of whom were pretreated with chemotherapy excluding anthracyclines, entered the study. The doses were: IDA 45 mg/m2 orally on 3 consecutive days every 28 days: ADRIA 75 (60) mg/m2 intravenously every 21 days. A complete + partial response (CR + PR) was observed in 11/37 (30%) evaluable cases treated with IDA and in 6/19 (32%) cases treated with ADRIA. If all the patients were included, the CR + PR remission rates were 27.5 and 27%, respectively. There were no significant differences as regards time to remission, duration of remission and survival. None of 10 cases who crossed over the treatments responded to the second therapy. The most frequent side effects of IDA were myelosuppression and nausea/vomiting. The only significant statistical difference between the two anthracyclines was the lower incidence of alopecia after IDA. Although there were 3 cases of cardiotoxicity after ADRIA, 2 of which severe, no case of clinical cardiotoxicity was observed after IDA. The present study confirms that orally administered IDA is an active agent in advanced breast cancer.
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PMID:Comparative phase II study of idarubicin versus doxorubicin in advanced breast cancer. 221 99

We have performed two Phase I trials of the combination of dipyridamole, 5-fluorouracil (5-FU), and folinic acid in patients with advanced refractory malignancy, based upon in vitro evidence that dipyridamole can modulate the cytotoxicity of 5-FU. In the first trial, patients were treated every 4 wk with dipyridamole (50 mg/m2) p.o. every 6 h on Days 0 to 6, beginning 24 h prior to the i.v. administration of folinic acid (200 mg/m2) and escalating doses of i.v. 5-FU on Days 1 to 5. The maximum tolerated daily dose of 5-FU that could be given with this combination was 375 mg/m2. Because dipyridamole is extensively bound to plasma proteins, it was hypothesized that the concentrations of free dipyridamole achieved with a dose of 50 mg/m2 were inadequate to modulate the cytotoxicity of 5-FU and folinic acid. Therefore, a second Phase I trial of escalating dose of p.o. dipyridamole was performed. Folinic acid (200 mg/m2) and 5-FU (375 mg/m2) were given i.v. on Days 1 to 5 every 4 wk, beginning 24 h after the start of therapy with dipyridamole; dipyridamole was administered p.o. on Days 0 to 6 at doses of 75, 100, 125, 150, 175, or 200 mg/m2/dose to successive cohorts of patients. Dose-limiting neutropenia, mucositis, and nausea were produced at a dose of 200 mg/m2/dose; the recommended dose of dipyridamole for use in Phase II studies is 175 mg/m2 p.o. every 6 h, or 700 mg/m2/day. At this dose, a mean peak plasma concentration of total dipyridamole of 16.32 mumol and a mean peak plasma concentration of free dipyridamole of 38.30 nmol were observed. Trough concentrations of free dipyridamole averaged 60% of the peak concentrations. Objective antitumor responses were seen in a number of tumor types; five of 13 patients with breast cancer treated with high-dose p.o. dipyridamole, 5-FU, and folinic acid responded. High-dose p.o. dipyridamole can produce plasma concentrations of free dipyridamole within the range shown to modulate the cytotoxicity of 5-FU and other agents. Phase II trials of this combination are justified.
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PMID:Phase I trial of dipyridamole with 5-fluorouracil and folinic acid. 222 54

Retinoids have shown a tumor growth inhibition and a synergistic activity with hormonal manipulations in human breast cancer cell lines and rat mammary carcinoma. To investigate the potential usefulness of this synergistic activity in human breast cancer, 33 postmenopausal patients with advanced disease were treated with the combination of tamoxifen (10 mg p.o. three times a day) and retinyl acetate (300,000 IU p.o. daily). Out of 31 evaluable patients, 3 achieved complete response, 9 partial response (overall response rate: 38.5%, 95% confidence interval = 21%-56%) and 16 (52%) showed no change. The median duration of response was 11.5 months (range: 3-19+ months), while the 2-year overall survival rate for the entire group of patients was 63%. Toxicity was generally mild, hot flushes, nausea (and/or vomiting), headache and cutaneous itching being the most frequent side-effects. Only 1 patient discontinued treatment for severe toxicity. These preliminary results suggest that the combination of tamoxifen and high-dose retinyl acetate is a safe and effective regimen for breast cancer patients. However, the study design does not allow us to establish whether the very low rate of early disease progression we observed might be related to a possible synergistic effect between retinoids and antiestrogens or rather to the quite indolent disease of the patients who have been selected for entry into this trial.
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PMID:Phase II study of tamoxifen and high-dose retinyl acetate in patients with advanced breast cancer. 222 42

We report a phase I/II study of the indole derivative, zindoxifene, an anti-oestrogen with intrinsic oestrogenic activity. We have treated 28 women with advanced breast cancer of whom 26 had received prior endocrine therapy. Oral zindoxifene doses ranged from 10 to 100 mg daily; doses were escalated in some patients. Twenty-five patients were assessed for response; the remaining three patients completed less than 3 weeks of treatment. There were no objective responses; disease stabilised in seven patients for up to 5 months and progressed in the remaining 18. Five patients (including three treated with tamoxifen) responded to subsequent endocrine therapy. Nausea, which was dose-limiting, affected half of the patients treated with 80 mg daily. Metabolites of zindoxifene were detectable in serum at all doses used, and sex hormone binding globulin (SHBG) levels showed a strong tendency to rise at the higher doses, indicating that zindoxifene is absorbed and has biological activity. We conclude that zindoxifene in the doses used in this study has only marginal therapeutic activity in the treatment of advanced breast cancer.
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PMID:Phase I/II study of the anti-oestrogen zindoxifene (D16726) in the treatment of advanced breast cancer. A Cancer Research Campaign Phase I/II Clinical Trials Committee study. 232 14

Platinum-based combination chemotherapy regimens (CAP or CMF + cisplatin) were used for the treatment of disseminated breast cancer. Response rate for the CAP regimen was 47.5%. The most frequent side-effects were nausea, vomiting, nephrotoxicity and myelosuppression. Relationship between survival and response was identified.
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PMID:[Chemotherapy of disseminated forms of breast cancer using platinum derivatives]. 234 95


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