The effectiveness of behavioral intervention for reduction of nausea and vomiting in children and adolescents receiving chemotherapy.

1984 ◽  
Vol 2 (6) ◽  
pp. 683-690 ◽  
Author(s):  
L Zeltzer ◽  
S LeBaron ◽  
P M Zeltzer
Keyword(s):  
Children And Adolescents ◽  
Behavioral Intervention ◽  
Nausea And Vomiting ◽  
Baseline Measurement ◽  
Symptom Ratings ◽  
Nausea And Emesis ◽  
To Receive ◽  
Supportive Counseling

Fifty-one children 6-17 years of age rated the severity of nausea, vomiting, and the extent to which chemotherapy bothered them during each course of chemotherapy. Sixteen patients had no symptoms and the doses administered to 16 others were not constant so that matched courses could not be assessed. After baseline measurement of two matched courses, the remaining 19 patients were randomized to receive hypnosis or supportive counseling during two more matched courses. An additional course with no intervention was assessed in half of the patients. No significant reduction of symptoms was demonstrated prior to intervention. However, intervention with both hypnosis and supportive counseling was associated with significant reductions in nausea, vomiting, and the extent to which these symptoms bothered patients (all p less than 0.001). Also, after termination of intervention, symptom ratings remained significantly lower than baseline. The data indicate that chemotherapy-related nausea and emesis in children can be reduced with behavioral intervention and that reductions are maintained after intervention has been discontinued.

High-dose intravenous metoclopramide versus combination high-dose metoclopramide and intravenous dexamethasone in preventing cisplatin-induced nausea and emesis: a single-blind crossover comparison of antiemetic efficacy.

1985 ◽  
Vol 3 (2) ◽  
pp. 245-251 ◽  
Author(s):  
S B Strum ◽  
J E McDermed ◽  
D F Liponi
Keyword(s):  
Patient Preference ◽  
Nausea And Vomiting ◽  
High Dose ◽  
Chemotherapy Response ◽  
Antiemetic Efficacy ◽  
Study Results ◽  
Nausea And Emesis ◽  
To Receive ◽  
Single Blind ◽  
Crossover Comparison

We tested the safety and antiemetic effectiveness of intravenous (IV) dexamethasone (DXM) as an adjunct to high-dose IV metoclopramide (MCP) to prevent nausea and vomiting induced by high-dose cisplatin chemotherapy. Response was determined by using objective and subjective criteria. Thirty patients were randomly assigned to receive MCP alone at a dose of 2 mg/kg IV for three doses or the same dose of MCP plus 20 mg of DXM IV for three doses. Twenty evaluable patients received a second course of cisplatin and were crossed over to the opposite arm. Study results did not show a statistically significant advantage of combination MCP plus DXM over MCP alone using strict objective criteria for antiemetic response. However, patients subjectively preferred MCP plus DXM over MCP alone by nearly a 6:1 ratio, regardless of the randomization sequence. Although the addition of DXM does not appear to objectively improve emetic protection with high-dose MCP, we recommend MCP plus DXM to prevent nausea and vomiting induced by high-dose cisplatin chemotherapy when the use of steroids is not contraindicated, in view of patient preference for the combination.

scholarly journals Contribution to the treatment of nausea and emesis induced by chemotherapy in children and adolescents with osteosarcoma

2006 ◽  
Vol 124 (2) ◽  
pp. 61-65 ◽  
Author(s):  
Flavio Augusto Vercillo Luisi ◽  
Antônio Sérgio Petrilli ◽  
Cristiana Tanaka ◽  
Eliana Maria Monteiro Caran
Keyword(s):  
Children And Adolescents ◽  
Adverse Reactions ◽  
Randomized Study ◽  
Limiting Factor ◽  
Efficacy And Safety ◽  
Antiemetic Drug ◽  
Chi Squared ◽  
Nausea And Emesis ◽  
To Receive ◽  
Severe Adverse Reactions

CONTEXT AND OBJECTIVE: Chemotherapy-induced emesis is a limiting factor in treating children with malignancies. Intensive chemotherapy regimens along with emetogenic drug administration have increased the frequency and severity of emesis and nausea. Our study was designed to consider the importance of this problem and the need for improvement in emesis treatment for patients receiving chemotherapy. Our objective was to compare the efficacy and safety of the antiemetic drug granisetron and a regimen of metoclopramide plus dimenhydrinate. DESIGN AND SETTING: Open, prospective and randomized study at Instituto de Oncologia Pediátrica, Department of Pediatrics, Universidade Federal de São Paulo. METHODS: From February to August 1994, 26 patients (mean age: 14 years) with osteosarcoma received 80 chemotherapy cycles of iphosphamide (2,500 mg/m²) plus epirubicin (75 mg/m²) or carboplatin (600 mg/m²), or epirubicin (75 mg/m²) plus carboplatin (600 mg/m²). Eighty chemotherapy treatments were analyzed regarding nausea and vomiting control. Patients were randomized to receive either a single dose of granisetron (50 µg/kg) or metoclopramide (2 mg/kg) plus dimenhydrinate (5 mg/kg infused over eight hours). Emesis and nausea were monitored for 24 hours by means of the modified Morrow Assessment of Nausea and Emesis. Statistical analysis utilized the chi-squared, Student t and Mann-Whitney tests, plus data exploration techniques. RESULTS: 62.5% of the patients undergoing chemotherapy responded completely to granisetron, whereas 10% responded to metoclopramide plus dimenhydrinate (p < 0.0001). No severe adverse reactions were found in either of the treatments given. CONCLUSION: In children and adolescents with osteosarcoma, granisetron was safe and more efficient than metoclopramide plus dimenhydrinate for controlling chemotherapy-induced emesis and nausea.

Pirenzepine in Non-Ulcer Dyspepsia: A Double-Blind Multicentre Trial

1990 ◽  
Vol 18 (1) ◽  
pp. 16-20 ◽  
Author(s):  
P.M. Smith ◽  
A.H. Troughton ◽  
F. Gleeson ◽  
J. Walters ◽  
C.F. McCarthy
Keyword(s):  
Abdominal Pain ◽  
Placebo Group ◽  
Adverse Effects ◽  
Multicentre Study ◽  
Multicentre Trial ◽  
Nausea And Vomiting ◽  
Double Blind ◽  
Non Ulcer Dyspepsia ◽  
Upper Abdominal ◽  
To Receive

In a double-blind multicentre study to compare pirenzepine with placebo in non-ulcer dyspepsia, 71 patients were randomized to receive 50 mg pirenzepine or placebo given orally twice daily for 4 weeks. The trial was not completed by five patients in the pirenzepine group and six in the placebo group. There were no significant differences between the groups in respect to changes in total symptoms (upper abdominal pain, nausea and vomiting, early satiety and postprandial bloating, eructation and pyrosis) scores and outcome, although 27/35 (77%) patients receiving pirenzepine were cured or improved compared with 22/36 (61%) receiving the placebo. Adverse effects were reported by 13 (37%) patients treated with pirenzepine and by six (17%) treated with placebo, seven withdrawing due to adverse effects.

A phase III, randomized, double-blind, multicenter, active control study of fosnetupitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving cisplatin-based highly emetogenic chemotherapy (HEC): CONSOLE.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12099-12099
Author(s):  
Yoshimasa Shiraishi ◽  
Akito Hata ◽  
Naoki Inui ◽  
Morihito Okada ◽  
Masahiro Morise ◽  
...  
Keyword(s):  
Study Drug ◽  
Incidence Rates ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Secondary Endpoints ◽  
To Receive ◽  
Age Category

12099 Background: Fosnetupitant (FN) is a phosphorylated pro-drug of netupitant that has high binding affinity for the neurokinin-1 (NK-1) receptor and a long half-life of 70 h. This phase 3 study is the first head-to-head study to compare two NK-1 receptor antagonists, FN and fosaprepitant (FA), in combination with palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (JapicCTI-194611). Methods: Patients scheduled to receive cisplatin (≥70 mg/m2) -based chemotherapy were randomly assigned 1:1 to receive FN 235 mg or FA 150 mg, in combination with palonosetron 0.75 mg and dexamethasone (9.9 mg on day 1, 6.6 mg on days 2-4). The stratification factors were sex, age category (<55 vs. ≥55 years), and site. The primary endpoint was the complete response (CR; no emetic events and no rescue medication) rate, stratified by sex and age category, during the overall phase (0-120 h) to show the non-inferiority (margin, -10%) of FN to FA. The secondary endpoints were: CR rate, complete protection rate, total control rate, no nausea rate, no emetic events rate in each period [i.e., acute (0-24 h), delayed (24-120 h), overall, 0-168 h and 120-168 h], time to treatment failure, and safety, including injection site reactions (ISRs). Assessment of efficacy was continued until 168 h after the initiation of cisplatin. Some eligible patients were evaluated for safety and efficacy of FN for up to four cycles. Results: Between February 2019 and March 2020, total 795 patients were enrolled in the study. The study drug was administered to 785 patients (n=392 in FN vs. n=393 in FA), and all of them were evaluated for efficacy and safety. Baseline characteristics were generally balanced between the two groups. The adjusted overall CR rate was 75.2% in FN vs. 71.0% in FA [MH common risk difference, 4.1%; 95% CI, -2.1% to 10.3%), thus demonstrating non-inferiority of FN to FA. Regarding the other secondary endpoints of efficacy until 168 h, FN was favorable against FA, especially the CR rate during 0-168 h (73.2% in FN vs. 66.9% in FA) (Table). The incidence rates of treatment-related adverse events were 22.2% in FN vs. 25.4% in FA, whereas those of ISRs with any cause or with treatment-related were 11.0% or 0.3% in FN vs 20.6% or 3.6% in FA, respectively ( p<0.001). Conclusions: FN demonstrated non-inferiority to FA, with a favorable safety profile and lower risk for ISRs. For the period beyond 120 h after initiation of chemotherapy, FN may have the potential to improve the prevention of “beyond delayed” CINV. Clinical trial information: JapicCTI-194611. [Table: see text]

scholarly journals A Randomized Double-Blinded Comparison of Metoclopramide, Ondansetron and Cyclizine in Day-Case Laparoscopy

1996 ◽  
Vol 24 (5) ◽  
pp. 546-551 ◽  
Author(s):  
S. A. Watts
Keyword(s):  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Relative Efficacy ◽  
Day Case ◽  
Detectable Difference ◽  
Double Blinded ◽  
To Receive ◽  
Significant Nausea ◽  
Antiemetic Agents

This study determined the overall incidence of postoperative nausea and vomiting (PONV) in 38 patients undergoing laparoscopic gynaecological procedures who received a standardized propofol/isoflurane anaesthetic but no pre-operative antiemetic. A further 166 patients similarly anaesthetized were then randomly allocated to receive either metoclopramide 10 mg, ondansetron 4 mg, or cyclizine 50 mg as an intravenous antiemetic immediately pre-induction. Overall incidence of PONV was determined for all groups and the relative efficacy of the three antiemetic agents assessed. Fifty per cent of patients in the initial group (no antiemetic) reported significant nausea and/or vomiting up to 24 hours postoperatively. The incidence of PONV in the metoclopramide group was 24%, in the ondansetron group 20%, and in the cyclizine group 51%. There was no detectable difference in relative efficacy between ondansetron 4 mg and metoclopramide 10 mg. The incidence of PONV in the group who received cyclizine was similar to that found in the pilot group who received no PONV prophylaxis. Both metoclopramide and ondansetron may potentially decrease the incidence of PONV following gynaecologic laparoscopy by up to 50% when administered intravenously prior to a propofol/isoflurane anaesthetic.

scholarly journals Lack of Efficacy of Propofol in the Treatment of Early Postoperative Nausea and Vomiting

1998 ◽  
Vol 26 (4) ◽  
pp. 366-370 ◽  
Author(s):  
I. Harper ◽  
E. Della-Marta ◽  
H. Owen ◽  
J. Plummer ◽  
A. Ilsley
Keyword(s):  
Low Dose ◽  
Dose Range ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Test Drug ◽  
Gynaecological Surgery ◽  
Treatment Groups ◽  
Sedation Scores ◽  
To Receive ◽  
Rescue Antiemetic

The anti-nauseant efficacy of low-dose propofol was investigated in a blinded, randomized trial. Patients who complained of nausea and/or vomiting following laparoscopic gynaecological surgery and who requested antiemetic were randomly assigned to receive placebo, propofol 3 mg, propofol 9 mg or propofol 27 mg by intravenous injection. Nausea, vomiting and sedation were recorded by a blinded observer for 90 minutes following administration of the test drug, prior to discharge, and 24 hours following surgery. Rescue antiemetic (droperidol 1.0 mg IV) was available from 10 minutes after administration of test drug. Propofol failed to reduce nausea scores and did not reduce the incidence of vomiting. Numbers of patients receiving rescue antiemetic were similar in the four treatment groups. In the first 10 minutes following test drug administration, sedation scores were increased by propofol in a dose-related manner. We conclude that, in the dose range studied, propofol is ineffective for the treatment of nausea and vomiting occurring soon after laparoscopic gynaecological surgery.

scholarly journals EMDR Individual Protocol for Paraprofessional Use: A Randomized Controlled Trial With First Responders

2013 ◽  
Vol 7 (2) ◽  
pp. 55-64 ◽  
Author(s):  
Ignacio Jarero ◽  
Carolina Amaya ◽  
Martha Givaudan ◽  
Alaide Miranda
Keyword(s):  
Controlled Trial ◽  
First Responders ◽  
Global Improvement ◽  
Randomized Controlled ◽  
Posttraumatic Symptoms ◽  
Significant Difference ◽  
To Receive ◽  
Nonsignificant Decrease ◽  
Supportive Counseling

The eye movement desensitization and reprocessing (EMDR) individual protocol for paraprofessional use in acute trauma situations (EMDR-PROPARA) is part of a project developed at the initiative of Dr. Francine Shapiro. This randomized clinical trial examined the effectiveness of the protocol administered by experienced EMDR therapists. There were 39 traumatized first responders on active duty randomly assigned to receive two 90-min sessions of either EMDR-PROPARA or of supportive counseling. Participants in the EMDR-PROPARA group showed benefits immediately after treatment, with their scores on the Short PTSD Rating Interview (SPRINT) showing further decreases at 3-month follow-up. In comparison, supportive counseling participants experienced a nonsignificant decrease after treatment and an increase in the SPRINT scores at the second follow-up. The significant difference between the two treatments provides preliminary support for EMDR-PROPARA’s effectiveness in reducing severity of posttraumatic symptoms and subjective global improvement. More controlled research is recommended to evaluate further the efficacy of this intervention.

Treatment of chemotherapy-induced breakthrough nauea and vomiting

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20536-e20536 ◽  
Author(s):  
R. M. Navari ◽  
S. E. Gray
Keyword(s):  
Serotonin Receptor ◽  
Rescue Therapy ◽  
Performance Status ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Ecog Performance Status ◽  
Difficult Situation ◽  
Serotonin Receptor Antagonists ◽  
Drug Classes ◽  
To Receive

e20536 Background: Patients may experience breakthrough nausea and vomiting (BNV) despite adequate prophylaxis for chemotherapy-induced nausea and vomiting (CINV). BNV presents a difficult situation as treatment of ongoing nausea and vomiting is challenging. We investigated three different drug classes for the treatment of BNV: phenothiazines (prochlorperazine)(Pro), dopamine-serotonin receptor antagonists (metoclopramide) (Meto), and a corticosteroid-thiobenzodiazepine combination (dexamethasone plus atypical antipsychotic olanzapine) (Dex-Olan). Methods: Adult patients, receiving moderately emetogenic chemotherapy and CINV prophylaxis with a 5-hydroxytryptamine-3 receptor antagonist and Dex pre-chemotherapy and Dex post-chemotherapy according to ASCO guidelines, who experienced BNV during the five days post-chemotherapy were randomized to receive Pro, 10 mg IV, and 10 mg, po, bid for three days; Meto, 20 mg IV, and 10 mg, po, bid for 3 days; or Dex, 20 mg IV and Olan, 5 mg, po, bid for three days. All patients also received at least one liter of IV fluids during the IV phase of their treatment. Patients were excluded if they had undergone rescue therapy with any of the study agents. Beginning with the first day of treatment for BNV (day 1) and daily through day 5, patients recorded episodes of vomiting/retching, nausea, other symptoms utilizing the M.D. Anderson Symptom Inventory, and the utilization of any additional rescue therapy. One hundred six patients (median age 61, range 37 - 85, 60 males, ECOG performance status ≤ 2) consented to the protocol and 100 were evaluable. Results: A complete response (no emesis, no additional rescue) for the five days post-initiation of BNV treatment was recorded for 7 of 35 patients (20%) in the Pro regimen, 12 of 33 patients (36%) receiving the Meto regimen, and 21 of 32 patients (66%) receiving the Dex-Olan regimen. There were no Grade III or IV treatment related toxicities. Conclusion: The combination of Dex-Olan was an effective treatment for BNV and was significantly more effective than Pro or Meto alone. No significant financial relationships to disclose.

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