Use of Low Dose Olanzapine for the Control of Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy in a Rural Medical College in Etawah District, Uttar Pradesh, India

2021 ◽  
Vol 6 (34) ◽  
pp. 3211-3216
Author(s):  
Kailash Kumar Mittal ◽  
Parveen Mendiratta ◽  
Nishu Bala
Keyword(s):  
Receptor Antagonist ◽  
Low Dose ◽  
Uttar Pradesh ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Nk1 Receptor ◽  
Receptor Antagonists ◽  
Highly Emetogenic Chemotherapy ◽  
Medical College

BACKGROUND Chemotherapy-induced nausea and vomiting (CINV) is a frequent and feared adverse effect of cancer chemotherapy. International guidelines recommend combinations of 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists, dexamethasone, and/or neurokinin-1 (NK1) receptor antagonists for the control of CINV in patients receiving highly emetogenic chemotherapy (HEC) as a part of their treatment. Even though, nausea in delayed period is less controlled and poses a major concern for these patients. METHODS This open label, prospective study was conducted in a rural medical college in Etawah District in Uttar Pradesh, India from November 2017 to November 2018 over a period of 1 year to observe the efficacy of low dose (5 mg OD) olanzapine in combination with standard anti-emetic regimen for the prevention of CINV. Olanzapine is a food and drug administration (FDA) approved antipsychotic drug that has anti-emetic activity and has shown to improve CINV. Low dose olanzapine along with a standard combination of ondansetron, dexamethasone and aprepitant was given to patients receiving highly emetogenic chemotherapy (Cisplatin >70 mg/m2 or doxorubicin-cyclophosphamide combination). CINV was assessed using common toxicity criteria of adverse events (CTCAE) version 5.0. RESULTS Complete response to nausea was observed in 90.90 %, 60.60 % and 54.54 % in acute, delayed and overall period respectively. Complete response to vomiting was observed in 96.96 %, 69.69 % and 66.66 % in acute, delayed and overall period respectively. Complete response to Grade-2 (or above) nausea was observed in 96.96 %, 93.93 % and 90.90 % in acute, delayed and overall period, respectively. Daytime Grade -3 somnolence which was seen in 2/33 patients (6.06 %) was attributable to olanzapine. Patients receiving olanzapine were more likely to have complete response of nausea and emesis in the early, late, and overall assessment periods especially of higher grade (G2 and G3). CONCLUSIONS The authors concluded that low dose olanzapine 5 mg OD combined with an NK1- receptor antagonist, a 5-HT3–receptor antagonist, and dexamethasone is safe and efficacious in the prevention of CINV in patients receiving HEC. KEYWORDS Olanzapine, Low Dose, CINV, HEC

Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Trial (CLOG1302 study)

2017 ◽  
Vol 35 (31) ◽  
pp. 3558-3565 ◽  
Author(s):  
Lingyun Zhang ◽  
Xiujuan Qu ◽  
Yuee Teng ◽  
Jing Shi ◽  
Ping Yu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Phase Iii Trial ◽  
Delayed Nausea

Purpose We examined the efficacy and safety of thalidomide (THD) for the prevention of delayed nausea and vomiting in patients who received highly emetogenic chemotherapy (HEC). Patients and Methods In a randomized, double-blind, active-controlled, phase III trial, chemotherapy-naive patients with cancer who were scheduled to receive HEC that contained cisplatin or cyclophosphamide-doxorubicin/epirubincin ≥ 50 mg/m2 regimens were randomly assigned to a THD group (100 mg twice daily on days 1 to 5) or placebo group, both with palonosetron (0.25 mg on day 1) and dexamethasone (12 mg on day 1; 8 mg on days 2 to 4). Primary end point was complete response to vomiting—no emesis or use of rescue medication—in the delayed phase (25 to 120 h). Nausea and anorexia on days 1 to 5 were evaluated by the 4-point Likert scale (0, no symptoms; 3, severe). Quality of life was assessed by the European Organization for Research and Treatment of Cancer QLQ-C30 version 3 questionnaire on days −1 and 6. Results Of 656 patients, 638 were evaluable: 317 in the THD group and 321 in the control group. Compared with placebo, delayed and overall (0 to 120 h) complete response rates to vomiting were significantly higher with THD: 76.9% versus 61.7% ( P < .001) and 66.1% versus 53.3% ( P = .001), respectively. Rates of no nausea were also higher in the THD group (delayed: 47.3% v 33.3%; P < .001; overall: 41% v 29.6%; P = .003), and mean scores of anorexia were lower overall (0.44 ± 0.717 v 0.64 ± 0.844; P = .003). Adverse effects were mild to moderate. The THD group had increased sedation, dizziness, constipation, and dry mouth, but experienced better quality of life after chemotherapy. Conclusion Thalidomide combined with palonosetron and dexamethasone significantly improved HEC-induced delayed nausea and vomiting prevention in chemotherapy-naive patients.

scholarly journals Ramosetron versus Palonosetron in Combination with Aprepitant and Dexamethasone for the Control of Highly-Emetogenic Chemotherapy-Induced Nausea and Vomiting

2020 ◽  
Vol 52 (3) ◽  
pp. 907-916 ◽  
Author(s):  
Jin Hyoung Kang ◽  
Jung Hye Kwon ◽  
Yun-Gyoo Lee ◽  
Keon Uk Park ◽  
Ho Jung An ◽  
...  
Keyword(s):  
Daily Life ◽  
Complete Response ◽  
Risk Difference ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Complete Protection ◽  
Highly Emetogenic Chemotherapy ◽  
Secondary Endpoints ◽  
To Receive

PurposeThe purpose of this study was to compare ramosetron (RAM), aprepitant (APR), and dexamethasone (DEX) [RAD] with palonosetron (PAL), APR, and DEX [PAD] in controlling highly-emetogenic chemotherapy (HEC)–induced nausea and vomiting. Materials and MethodsPatients were randomly assigned (1:1) to receive RAD or PAD:RAM (0.3 mg intravenously) or PAL (0.25 mg intravenously) D1, combined with APR (125 mg orally, D1 and 80 mg orally, D2-3) and DEX (12 mg orally or intravenously, D1 and 8 mg orally, D2-4). Patients were stratified by gender, cisplatin-based chemotherapy, and administration schedule. The primary endpoint was overall complete response (CR), defined as no emesis and no rescue regimen during 5 days of HEC. Secondary endpoints were overall complete protection (CP; CR+nausea score < 25 mm) and total control (TC; CR+nausea score < 5 mm). Quality of life was assessed by Functional Living Index Emesis (FLIE) questionnaire on D0 and D6.ResultsA total of 279 patients receiving RAD (n=137) or PAD (n=142) were evaluated. Overall CR rates in RAD and PAD recipients were 81.8% and 79.6% (risk difference [RD], 2.2%; 95% confidence interval [CI], −7.1 to 11.4), respectively. Overall CP and TC rates for RAD and PAD were 56.2% and 58.5% (RD, −2.3%; 95% CI, −13.9 to 9.4) and 47.5% vs. 43.7% (RD, 3.8%; 95% CI, −7.9 to 15.5), respectively. FLIE total score ≥ 108 (no impact on daily life) was comparable between RAD and PAD (73.9% vs. 73.4%, respectively). Adverse events were similar between the two groups.ConclusionIn all aspects of efficacy, safety and QOL, RAD is non-inferior to PAD for the control of CINV in cancer patients receiving HEC.

Prevention of Highly Emetogenic Chemotherapy-Induced Vomiting: A Double Blind, Randomized Crossover Study to Compare Pancopride (LAS 30451) and Pancopride plus Dexamethasone

1995 ◽  
Vol 81 (6) ◽  
pp. 432-434 ◽  
Author(s):  
Enrique Aranda ◽  
Isidoro C. Barneto ◽  
Ma. Jesus Rubio ◽  
Rosario Gonzalez ◽  
Antonio Garcia ◽  
...  
Keyword(s):  
Side Effects ◽  
Crossover Study ◽  
Receptor Antagonist ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Complete Protection ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Order Of Administration ◽  
Randomized Crossover Study

Aims Pancopride (PNC) is a new 5HT3 receptor antagonist which has demonstrated complete protection from nausea and vomiting in 25-73% of patients treated with highly emetogenic chemotherapy. A double-blind, randomized crossover study was carried out to assess whether the addition of dexamethasone (DXM) to PNC increases the antiemetic efficacy. Methods PNC (0.2 mg/kg. i.v. 30 min before chemotherapy) plus placebo (PLC) was compared with PNC (same dose and schedule) plus DXM (20 mg. i.v. immediately before PNC). In the second cycle, patients received the alternative antiemetic treatment. Eighty patients were included in the study (PNC+DXM=39, PNC+PLC=41), 29 of whom were women and 51 men. Fifty-four percent of the patients in the PNC+DXM group and 59% of those in the PNC+PLC group received chemotherapy containing cisplatin. Seventy-seven patients completed the first cycle and 70 the second. Results Complete protection was obtained in 19/16 patients (50/46%) with PNC+PLC and in 32/22 (82/63%) with PNC+DXM (P<0.001). Latency was significantly longer in the PNC+DXM group. The efficacy of both treatments was unaffected by the order of administration. Side effects were mild in both groups. Conclusions The combination of PNC+DXM is more efficacious than PNC+PLC in protection against highly emetogenic chemotherapy-induced vomiting.

scholarly journals Impact of oral palonosetron in improving quality of life as compared to other oral 5-HT3 antagonists in delayed chemotherapy induced nausea and vomiting in patients of head and neck cancer

2019 ◽  
Vol 8 (3) ◽  
pp. 493
Author(s):  
Anubhuti Khare ◽  
Varsha Mandloi ◽  
Abhishek Shrivastava ◽  
Arun Kumar Shrivastava ◽  
Prashant Wadagbalkar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Head And Neck ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Receptor Antagonists ◽  
Medical College ◽  
Delayed Cinv ◽  
Gandhi Medical College ◽  
Oral Ondansetron

Background: Chemotherapy induced nausea and vomiting (CINV) remains one of the most common and debilitating complications of highly emetogenic chemotherapy (HEC). This study was undertaken to evaluate palanosetron against other 5-HT3 receptor antagonists in preventing delayed CINV with the aim of achieving complete response (CR) and improving quality of life (QoL).Methods: This was a prospective, observational study conducted on 75 histopathologically proven patients of squamous cell carcinoma of Head and Neck (H&N), who came to the Department of Radiation Oncology, Gandhi Medical College and Hamidia Hospital, Bhopal from January to December 2015. Standard protocol based chemotherapy containing highly emetogenic cisplatin based chemotherapy was administered to all the patients. For prevention of delayed chemotherapy induced nausea and vomiting all patients were prescribed oral 5-HT3 antagonists. Oral Ondansetron 4mg TDS was given to cohort 1, oral Granisetron 1 mg BD to cohort2 and oral Palanosetron 0.5mg OD was given to cohort 3. They were graded as complete response when they did not have complains of nausea and vomiting.Results: In Ondansetron, Granisetron and in Palanosetron cohort 29%, 53% and 98% patients had complete response.Conclusions: Palanosetron appears superior. Our study was conducted on handfull of patients and compared palanosetron against only two 5-HT3 receptor antagonists, so a larger study is suggested to establish the efficacy and better response of palanosetron.

Chemotherapy-Induced Nausea and Vomiting (CINV) in Hematologic Malignancy Patients Receiving Multi-Day Highly Emetogenic Chemotherapy (HEC)

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2410-2410
Author(s):  
Lee S. Schwartzberg ◽  
Eric J. Roeland ◽  
Paul J.E. Miller ◽  
Mark S. Walker
Keyword(s):  
Research Funding ◽  
Hematologic Malignancy ◽  
Day Treatment ◽  
Complete Response ◽  
Primary Objective ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
High Dose ◽  
Cell Transplant ◽  
Highly Emetogenic Chemotherapy

Abstract INTRODUCTION Despite recent advances in CINV prophylaxis, many questions remain unanswered including optimal treatment for hematologic malignancy (HM) patients receiving multi-day chemotherapy regimens. As preparation for stem cell transplant (SCT) and for high grade HM, highly emetogenic chemotherapy (HEC) containing regimens are often utilized. International guidelines recommend a three-drug combination of a 5-HT3receptor antagonist (5-HT3 RA), an NK-1 receptor antagonist (NK-1 RA) and dexamethasone (dex) before HEC. Little is known about CINV prevention in HM multi-day regimens. METHODS We conducted a prospective observational study in U.S. research centers with expertise in HM and SCT surveying providers and adult patients receiving up to 7 consecutive days of chemotherapy including at least one HEC drug. Those receiving concurrent radiation therapy were excluded as were patients taking antiemetics or having nausea and vomiting prior to initiation of chemotherapy. Patients completed a diary and a modified Functional Living Index - Emesis (FLIE) questionnaire daily, beginning at screening, during chemotherapy, and for up to 5 days after the last day of treatment. Daily use of scheduled antiemetics and rescue medication was collected. The primary objective was to survey patterns of CINV care for multi-day chemotherapy in HM and assess efficacy of the intervention. RESULTS Seventy-six patients were enrolled at 5 centers (range 8 -25 patients per center) between May 2015 and February 2016. Of the patients, 72 underwent pre-SCT conditioning and 4 multi-day chemotherapy for HM. Forty-nine (68%) were male and 58 (81%) were Caucasian; median age was 58 (range 22-74). The most common diagnoses were NHL, 27 (36%); multiple myeloma, 19 (25%); and AML, 15 (20%). Seventy-one patients completed all surveys. All received ≥ 1 HEC drug on day 1. The most common chemotherapy regimens were BEAM, 28 (37%), high-dose melphalan, 18 (26%), melphalan, fludarabine, and campath, 8 (11%) and fludarabine and cyclophosphamide, 4 (5%). Anti-emetic therapy was highly variable, both prior to day 1 chemotherapy and throughout multi-day treatment. On day 1 the most common regimens included: a combination of 5-HT3 RA, NK-1 RA, dex in 28 (37%); 5-HT3 RA + dex in 24 (32%); 5-HT3 RA alone in 9 (12%); 5-HT3 RA and metoclopramide in 2 (3%); other 10 (13%) and none documented 3 (4%). Complete response rate (defined as no vomiting and no use of rescue medications) was observed in 15 patients (20%); complete response by day ranged from 95% on day 1 to 46% on end of study day (p=0.041). Mean±SD nausea scores by FLIE increased from 19.9±3.1 pretreatment to 22.4±3.3 overall (p=0.0031). CONCLUSION Approaches to CINV in SCT and HM patients receiving multi-day HEC regimens are highly variable. A large majority of patients receiving multi-day chemotherapy are not achieving adequate control of nausea or vomiting. Additional clinical trials and development of evidence-based approaches to CINV prophylaxis in HM patients throughout multi-day chemotherapy are critical to improve supportive care. Disclosures Schwartzberg: Helsinn: Consultancy, Research Funding; Eisai: Consultancy; Tesaro: Consultancy; Heron: Consultancy. Roeland:Teva: Speakers Bureau; Insys: Consultancy; Helsinn: Consultancy; Heron: Consultancy; AstraZeneca: Consultancy, Research Funding; Eisai: Speakers Bureau.

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