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Assessing the impact of chemotherapy-induced nausea and vomiting on patients' daily lives: a modified version of the Functional Living Index-Emesis (FLIE) with 5-day recall.

BACKGROUND: The Functional Living Index-Emesis (FLIE), a patient-reported outcome measure, was originally developed to assess the impact of chemotherapy-induced nausea and vomiting (CINV) on patients' daily lives over the 3 days following chemotherapy. More recent studies of CINV include assessments covering the 5 days following chemotherapy in an effort to capture information during both the acute (within 24 h) and delayed (up to 5-7 days) phases of CINV. GOALS: To assess the measurement characteristics of a modified version of the FLIE with 5-day recall. Instrument reliability, validity, and missing data were assessed. PATIENTS AND METHODS: Data were collected from 183 patients receiving cisplatin >or=70 mg/m(2) as part of a phase IIb antiemetic trial of an NK-1 receptor antagonist (MK-0869). Patients recorded the number of vomiting episodes and nausea ratings in a 5-day daily diary. RESULTS: The 5-day FLIE had: (1) excellent internal consistency within FLIE Nausea and Vomiting domains (Cronbach's alpha 0.77-0.78), (2) acceptable construct validity shown by FLIE item-total correlations stronger within domains ( r=0.74-0.97) than across domains ( r=0.52-0.76), and (3) acceptable convergent validity as shown by moderate to strong correlations between FLIE domain scores and independent endpoints of emetic episodes, nausea ratings, and use of rescue medications. The extent of missing data was within acceptable limits with less than 2% of patients missing data. CONCLUSION: The 5-day FLIE had adequate measurement characteristics for studying the impact of CINV on patients' daily lives during the period covering both the acute and delayed phases.

Activities of Daily Living↗

An open study of methotrimeprazine in the management of nausea and vomiting in patients with advanced cancer.

INTRODUCTION: Nausea and vomiting are distressing symptoms affecting between 20% and 70% of patients with advanced cancer. Methotrimeprazine is a phenothiazine antipsychotic used in palliative care for the management of terminal agitation and nausea/vomiting but there is only anecdotal evidence to support its use in palliative care. AIM: To establish whether nausea/vomiting in palliative care patients is improved by the administration of low-dose methotrimeprazine. METHODS: Patients with advanced malignancy were entered at different treatment levels according to symptom severity. The dose was altered according to response (minimum dose 6.25 mg daily po, maximum 25 mg by 24-h subcutaneous infusion). Symptoms and side effects were recorded daily from 0 (baseline) to day 5 using a four-point scale. Any improvement in nausea/vomiting score was taken as a response. RESULTS: Sixty-five patients were entered. The cause of nausea and vomiting was multifactorial in the majority of patients, 35/65 (54%). As expected in a study of patients with poor performance status, the attrition rate was high. Of 53 patients evaluable for response at day 2, 33 (62%) showed some improvement in nausea or vomiting. At day 5, improvement was seen in 20/34 (58%). There was no significant change in "side effects" from baseline with time. CONCLUSION: These results suggest that methotrimeprazine has antiemetic activity.

Adult↗

Low-dose granisetron for prophylaxis of acute chemotherapy-induced nausea and vomiting: a pilot study.

OBJECTIVES: Chemotherapy-induced nausea and vomiting (QTNV) are very uncomfortable symptoms for patients with cancer, which can be circumvented in most of them with drug combinations containing serotonin receptor antagonists (5-HT3 receptor antagonists) such as granisetron. In an attempt to decrease costs of QTNV prophylaxis, we studied a lower dose regimen of granisetron. PATIENTS AND METHODS: Sixty patients with cancer scheduled to receive moderately/highly emetogenic chemotherapy were pretreated 1 h before with 0.5 mg granisetron p.o. combined with dexamethasone 20 mg i.v. RESULTS: We observed complete control for nausea, vomiting, and nausea and vomiting in 78% [95% confidence interval (CI), 67-89%], 61% (95% CI, 47.5-74.5%), and 58% (95% CI, 44.3-71.7%) of the patients, respectively. This regimen was very well tolerated; headache (35%), xerostomia (11%), and constipation (5%) were the most frequent adverse symptoms reported. CONCLUSIONS: The regimen with lower dose granisetron is effective for acute QTNV prophylaxis and offers a cheaper alternative for QTNV control. We feel that these encouraging results should be confirmed in a randomized comparative trial.

Adult↗

Acupuncture against chemotherapy-induced nausea and vomiting in pediatric oncology. Interim results of a multicenter crossover study.

GOALS: In this multicenter crossover study, our aim was to evaluate the efficacy and acceptance of acupuncture as a supportive antiemetic approach during highly emetogenic chemotherapy in pediatric oncology. PATIENTS AND METHODS: Eleven children receiving several courses of highly emetogenic chemotherapy for treatment of solid tumors were included. Randomization allocated patients to start chemotherapy either with antiemetic medication plus acupuncture or antiemetic medication alone. During all study courses, patients continued to receive their programmed and additional antiemetic medication as needed. Acupuncture was given at day 1 of chemotherapy and at subsequent days on patient's demand. The amount of baseline and additional antiemetic medication during chemotherapy was documented. Patients maintained a daily diary of vomiting episodes and completed an evaluated nausea score at the end of every course. Their body weight was taken before and after a chemotherapy course. MAIN RESULTS: Twenty-two courses with or without acupuncture were compared. The benefits of acupuncture in adolescents with respect to the reduction of additional antiemetic medication were observed. Acupuncture enabled patients to experience higher levels of alertness during chemotherapy and reduced nausea and vomiting. Except for needle pain, no side effects were noted. Patient's acceptance of acupuncture was high. CONCLUSION: Our data indicate that acupuncture might reduce antiemetic medication and episodes of vomiting in pediatric oncology.

Acupuncture Therapy↗

An assessment of aetiology-based guidelines for the management of nausea and vomiting in patients with advanced cancer.

STUDY AIM: The aim of this study was to assess the effectiveness of aetiology-based guidelines for the management of nausea and vomiting (N&V) in patients with advanced cancer. PATIENTS AND METHODS: This was a prospective study of 121 patients admitted to a hospice. Patients with N&V underwent assessments at presentation, 48 h and 1 week, to determine the aetiology of N&V and the response to treatment. Antiemetics were prescribed according to aetiology-based guidelines. RESULTS: Sixty-one patients (50%) had N&V during their admission: 21 (17%) had isolated nausea, 2 (2%) had isolated vomiting and 38 (31%) had combined N&V. During the assessment period, physicians altered their opinion about the primary cause of N&V in 26% of cases and finally expressed confidence about the aetiology in 75% of patients. The most common cause of N&V was impaired gastric emptying (contributing in 44% of patients), followed by chemical causes (33%) and bowel obstruction (19%). At 1 week, nausea was controlled in 56% of patients, and vomiting in 89% of patients, and residual symptoms were generally mild. CONCLUSIONS: An approach using aetiology-based guidelines in the management of N&V is moderately effective, although there are some patients with N&V refractory to standard antiemetic regimens.

Adult↗

Rationale for the use of a single fixed intravenous dolasetron dose for the prevention of cisplatin-induced nausea and vomiting. Pooled analysis of 14 clinical trials.

Dolasetron mesilate is a selective 5-HT3 receptor antagonist that prevents chemotherapy-induced and postoperative nausea and vomiting. For the majority of patients in intravenous dolasetron trials for chemotherapy-induced nausea and vomiting, dosing has been based on body weight (mg/kg). The approved weight-based dose is 1.8 mg/kg based on results of controlled clinical trials. However, trials of dolasetron evaluating oral doses for prevention of chemotherapy-induced emesis, and intravenous doses for prevention and treatment of postoperative emesis have used a fixed milligram dose. To identify an appropriate intravenous fixed milligram dose for the prevention of chemotherapy-induced nausea and vomiting, this analysis was performed to derive efficacy results for fixed milligram doses from pooled results obtained with dosing based on body weight. Intravenous dolasetron doses for 1,598 patients treated on a mg/kg basis (0.3, 0.6, 1.2, 1.8, 2.4, 3.0 and 5.0 mg/kg) in 14 clinical trials were converted to fixed milligram doses based on weight. Fixed-dose groups were established at doses of 50, 75, 100, 125, 150, and 200 mg. Doses less than or equal to the midpoint between two dose groups were included in the lower dose group. Pooled results showed that the 100 mg intravenous dolasetron dose group (who received actual doses of 88-112 mg) produced the highest rate (53%) of complete response (0 emetic episodes and no rescue medication in the 24-h period following initiation of chemotherapy).

Adolescent↗

A double-blind, randomised, parallel study comparing intravenous dolasetron plus dexamethasone and intravenous dolasetron alone for the management of fractionated cisplatin-related nausea and vomiting.

Fractionated cisplatin-containing regimens are routinely used for chemotherapy in certain types of cancer. Dolasetron has been shown to be effective in preventing acute emesis related to high-dose cisplatin chemotherapy over 24 h; its effectiveness has not been evaluated in fractionated cisplatin-containing chemotherapy. This trial was designed to assess the efficacy of dolasetron alone or dolasetron plus dexamethasone in preventing nausea and vomiting related to fractionated cisplatin chemotherapy. The patients were 210 cancer in-patients, who were randomised to receive 100 mg dolasetron i.v. or 100 mg dolasetron i.v. plus 20 mg dexamethasone before chemotherapy primarily with cisplatin (15-50 mg/m2) infused over < or =4 h for at least 2 but not more than 5 consecutive days. Dolasetron was administered to all patients 30 min before cisplatin. Dexamethasone was administered in double-blind fashion 5 min before cisplatin. Efficacy was measured at hour 24 of each study day using complete response (no vomiting and no rescue medication) and maximum severity of nausea, self-assessed by patients using a 100mm visual analogue scale. Most (198) of the patients completed the study and were evaluable. Overall complete response rates were significantly higher in the dolasetron plus dexamethasone group than in the dolasetron only group (72.9% vs. 40.8%, respectively; P<0.0001). Complete response rates on each study day were also significantly higher with dolasetron plus dexamethasone than with dolasetron alone (P<0.029), with an attenuated efficacy in the delayed phase in both groups. Chi-square test and logistic regression applied to daily response rates indicated a significant influence of treatment (day 1: P = 0.0002, day 2: P<0.0001, day 3: P = 0.0007, day 4: P = 0.0007, day 5: P = 0.029). Treatment and duration of chemotherapy exerted the only statistically significant subgroup effects on complete response (P<0.0001). Both treatments were administered safely. As seen with other 5-HT3 receptor antagonist antiemetics, the addition of dexamethasone to dolasetron significantly increases effectiveness in preventing nausea and vomiting related to fractionated cisplatin chemotherapy. Both dolasetron and dolasetron plus dexamethasone were well tolerated.

Adult↗

Omission of fentanyl during sevoflurane anesthesia decreases the incidences of postoperative nausea and vomiting and accelerates postanesthesia recovery in major breast cancer surgery.

PURPOSE: Our purpose was to investigate the effect of omission of fentanyl during sevoflurane anesthesia on the incidences of postoperative nausea and vomiting and on postanesthesia recovery in female patients undergoing major breast cancer surgery. METHODS: Female patients (American Society of Anesthesiologists [ASA] physical status [PS] class I-II; age, 28-84 years) undergoing major breast cancer surgery were randomized to one of two anesthesia maintenance groups: sevoflurane-fentanyl anesthesia (SF; n = 25) or fentanyl-free sevoflurane anesthesia (S; n = 26). All patients were administered with propofol 2 mg x kg(-1) intravenously for anesthesia induction, a laryngeal mask airway was placed, and they received rectal diclofenac and local infiltration anesthesia. Anesthesia was maintained with sevoflurane in oxygen-air and they breathed spontaneously. The patients in group SF received fentanyl 0.1 mg intravenously and those in group S received normal saline during anesthesia. RESULTS: Group SF revealed higher incidences of postoperative nausea (68% vs 27%) and vomiting (32% vs 8%) in the first 24 postoperative hours than group S. The median (25th-75th percentile) length of time from postanesthesia care unit (PACU) admission to ambulation was significantly longer in group SF (n = 23) at 195 min (158-219 min), than in group S, at 141 min (101-175 min). Two patients in group SF could not walk during the PACU stay. CONCLUSION: Omission of fentanyl during sevoflurane anesthesia, combined with diclofenac and local infiltration anesthesia, decreases the incidences of postoperative nausea and vomiting and accelerates postanesthesia recovery in patients undergoing major breast cancer surgery.

Aged↗

Chronic vomiting in children: new insights into diagnosis.

Chronic vomiting disorders with diverse causes are seen in children of all ages and present diagnostic and therapeutic challenges to pediatric gastroenterologists. Most patients are diagnosed by history, physical examination, and a basic work-up aimed at excluding obstructive and inflammatory causes. Intractable cases warrant further evaluation for clarification of the diagnosis. This review focuses on the pathophysiology of vomiting and four of the syndromes manifesting as chronic vomiting. It also includes a detailed exploration of the new tools available for evaluation of these syndromes.

Adolescent↗

Nausea and vomiting of pregnancy and association with pregnancy outcome.

The pattern of nausea and/or vomiting of pregnancy were investigated in a group of 414 predominantly white, upper middle-class women in Albany, New York; patterns were ascertained before their eighty-eighth day of gestation and followed up to the end of pregnancy. Of these, 89.4% reported at least some symptoms. This frequency is higher than reported previously, perhaps in part because extensive attempts were made in this study to ascertain symptoms. The incidence of vomiting was about 55%. Women with no symptoms of nausea and/or vomiting of pregnancy experienced a significantly greater proportion of nonviable pregnancy outcomes (fetal death). Increased intake of niacin during the first trimester was associated with decreased infant birth weight. This may be the result of quicker fetal maturation due to increased levels of protein intake.

Female↗

Pyridoxine for nausea and vomiting of pregnancy: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: Our purpose was to determine the effectiveness of pyridoxine for nausea and vomiting of pregnancy. STUDY DESIGN: During an 11-month period 342 women who first attended Chiang Mai University Hospital antenatal clinic at < or = 17 weeks' gestation were randomized to received either oral pyridoxine hydrochloride, 30 mg per day, or placebo in a double-blind fashion. Patients graded the severity of their nausea by a visual analog scale and recorded the number of vomiting episodes over the previous 24 hours before treatment and again during 5 consecutive days on treatment. RESULTS: There was a significant decrease in the mean of posttherapy minus baseline nausea scores in the pyridoxine compared with that in the placebo group (t test, p = 0.0008). There was also a greater reduction in the mean number of vomiting episodes, but the differences did not reach statistical significance (p = 0.0552). CONCLUSION: Pyridoxine is effective in relieving the severity of nausea in early pregnancy.

Adult↗

Distraction and relaxation training in the treatment of anticipatory vomiting: a single subject intervention.

A within-series phase change design (ABABC) was used to evaluate the effect of video distraction and relaxation in the treatment of a 29-year-old male with anticipatory vomiting associated with cancer chemotherapy. Heart rate, blood pressure, nausea ratings, and the occurrence of emesis were recorded during 18 chemotherapy treatments over a 9 month period. Video distraction initially inhibited vomiting but the treatment effects were not maintained. Subsequent relaxation training inhibited vomiting after two sessions. These effects were maintained for the remainder of the patient's chemotherapy protocol.

Adenocarcinoma↗

'Vomiting center' reanalyzed: an electrical stimulation study.

Electrical stimulation of the brainstem of 15 decerebrate cats produced stimulus-bound vomiting in only 4 animals. Vomiting was reproducible in only one cat. Effective stimulating sites were located in the solitary tract and reticular formation. Restricted localization of a 'vomiting center', stimulation of which evoked readily reproducible results, could not be obtained.

Animals↗

Transmission of a small round structured virus by vomiting during a hospital outbreak of gastroenteritis.

An outbreak of gastroenteritis due to a small round structured virus (SRSV) (Norwalk-like virus) occurred in an elderly care unit, affecting a total of 126 patients and staff. The outbreak caused major disruption to the provision of health care services by the unit over a 3-week period. Following the outbreak a study was undertaken to explore risk factors for acquisition of SRSV infection by health care workers on the unit. Exposure to patients nearby who were vomiting and the number of close contacts with ill patients were significantly related to the risk of developing gastroenteritis (P < 0.05). No significant increase in risk of developing gastroenteritis was found in nurses who cleaned vomit or faeces from affected patients. The findings suggest that aerosolization of vomit was of major importance in transmission of infection during the outbreak; the implications for infection control are discussed.

Caliciviridae Infections↗

Advances in the management of nausea and vomiting induced by non-cisplatin containing chemotherapeutic regimens.

Nausea and vomiting are the most feared toxicities of chemotherapy. Afferent impulses from the chemoreceptor trigger zone, peripheral sites, the cerebral cortex, or the vestibular center can initiate the emetic reflex. Antiemetic protection therefore requires interruption of appropriate emetogenic pathways. Since the chemoreceptor trigger zone contains numerous dopaminergic neurons, antidopaminergic agents including phenothiazines and metoclopramide have gained importance as antiemetics. However standard dose phenothiazines have limited efficacy while high dose metoclopramide may have excessive toxicity in the non-cisplatin setting. Recent advances have therefore centered on development of new classes of antiemetics. Corticosteroids have excellent activity alone or in combination with other antiemetic agents. Cannabinoids have recently been introduced into commercial use as antiemetics with particular activity against non-cisplatin chemotherapy. Benzodiazepines are active against anticipatory nausea and vomiting and are also used in combination antiemetic regimens. Although the vestibular center seems to have a lesser influence on chemotherapy-induced nausea and vomiting, vestibular blocking agents such as scopolamine may have a potential role as adjunctive antiemetics. Finally, appreciation of the role of serotonin (5-HT3) receptors in both peripheral and central emetic pathways may lead to a new class of antiserotonergic antiemetic agents.

Adrenal Cortex Hormones↗

Bulbospinal augmenting inspiratory neurons may participate in contractions of the diaphragm during vomiting in decerebrate dogs.

Contradictory results have been reported regarding the participation of bulbospinal inspiratory (BSI) neurons in vomiting contractions of the diaphragm in dogs and cats maintained at low and high end-tidal CO2 levels, respectively. To resolve this discrepancy, effects of CO2 levels on vomiting activities were observed in 159 BSI-neurons of paralyzed decerebrate dogs. About half of the BSI-neurons exhibited a vigorous burst with each fictive retch regardless of the CO2 level and 28 of 51 BSI-neurons produced a burst during the early phase of expulsion. These BSI-neurons were not concentrated in any particular area. While these results do not resolve the above contradiction, they do suggest that some BSI-neurons participate in the vomiting contraction of the diaphragm.

Abdominal Muscles↗

Therapeutic management of nausea and vomiting.

1. The aim of this study is to review the mechanisms implicated in nausea and vomiting and the treatment of these symptoms. 2. Metoclopramide, a benzamide, is the drug most frequently used to alleviate or abolish the majority of nausea and vomiting of different origin. Domperidone, which scarcely penetrates the central nervous system (CNS), is less used. 3. The treatment of vomiting induced by cytotoxic drugs is necessary to use a combination (two or more) of antiemetic drugs (metoclopramide, glucocorticoids, antihistamines, butyrophenones, anticholinergics, cannabinoids). Recently, antagonists of serotonergic (5-HT) receptors of the subtype 5-HT3 appear to possess interesting antiemetic properties and they have a promising future in this field. 4. Antagonists of dopamine receptors (benzamides, phenotiazines, butyrophenones and domperidone) induce adverse reactions in CNS (mainly extrapyramidal disorders), which are scarce with metoclopramide and practically absent with domperidone. These disorders must not suppress antiemetic therapy when it is needed.

Humans↗

Dronabinol and prochlorperazine in combination for treatment of cancer chemotherapy-induced nausea and vomiting.

Dronabinol (Marinol, Roxane Laboratories, Columbus, OH) and prochlorperazine were tested alone and in combination in a randomized, double-blind, parallel group, multicenter study. Patients were randomized to receive either 1) dronabinol 10 mg every 6 hr plus placebo; 2) placebo plus prochlorperazine 10 mg every 6 hr; or 3) dronabinol and prochlorperazine, each 10 mg every 6 hr. Antiemetic treatment was begun 24 hr prior to and continued for 24 hr after the last dose of chemotherapy; all was given orally. Only 29% of patients in group 3 versus 47% in group 1 and 60% in group 2 experienced nausea after chemotherapy. In addition, the median duration per episode and severity of nausea were significantly less with combination therapy. Vomiting occurred after chemotherapy in 41%, 55%, and 35% of patients in groups 1, 2, and 3, respectively. The median duration per episode of vomiting was 1 min in group 3 versus two in group 1 and four in group 2. Side effects, primarily CNS, were more common in group 1 than in group 2; addition of prochlorperazine to dronabinol appeared to decrease the frequency of dysphoric effects seen with the latter agent. The combination was significantly more effective than was either single agent in controlling chemotherapy-induced nausea and vomiting.

Adult↗