Is gabapentin effective for preventing delayed nausea and vomiting (NV) after moderately and highly emetogenic chemotherapy (CT)?

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18575-18575
Author(s):  
A. Menendez-Leal ◽  
C. Quijano ◽  
A. G. Menendez-Rivera
Keyword(s):  
Side Effects ◽  
Primary Endpoint ◽  
Emetogenic Chemotherapy ◽  
The Other ◽  
Nausea And Vomiting ◽  
Highly Emetogenic Chemotherapy ◽  
Good Tolerability ◽  
Other Hand ◽  
Delayed Nausea ◽  
Financial Relationships

18575 Background: Following previous institutional observations,this protocol was designed to evaluate the efficacy of Gabapentin in the prophylaxis of delayed CT induced NV. Methods: The main elegibility criteria was moderate and severe NV on previous CT cycles.Gabapentin 300 mg caps. was given as follows: One capsule day -2, two capsules day -1 and one capsule tid from days 1 to 5. 24 pats. were evaluated; 22 (92%) female, 2 (8%) male.CT included Doxorubicin/Ciclofosfamide 15 (62.5%), Cis-Platin 5 (21%), Other regimens 4 (17%). Previous prophylaxis for all pats. included a 5-HT3 Antagonist plus Dexametasone. Pats. were instructed to complete a two-page Questionaire: On page 1 pats. indicated the intensity of nausea according a scale shown there. On page two they indicated the number of vomits they had.This was made three times daily for five days. The primary endpoint was reduction of NV aftyer CT. Results: The reduction observed in the number of vomits was as follows: Number of pats. that experienced 0 Vomits: day 1 (CT): 14 (58.3%); day 2: 18 (75%); day 3: 20 (83.3%); day 4: 18 (75%); day 5: 22 (91.7%). On the other hand, pats. that did not respond and had three or more vomits daily: day 1: 5 (20.8%); day 2: 2 (8.3%); day 3: 1 (4.2%); day 4: 3 (12.5%); day 5: 2 (8.3%).Most pats. experienced a decrease in the intensity of nausea as well. No significant side effects were seen. Conclusions: Gabapentin seems to have some efficacy preventing delayed NV after moderately and highly emetogenic CT. These results together with it’s possible effect on acute NV and good tolerability warrant further studies. No significant financial relationships to disclose.

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.

Chemotherapy-induced Nausea and Vomiting—Where We Stand Now

2013 ◽  
Vol 09 (02) ◽  
pp. 1
Author(s):  
Rita Wickham ◽  
Keyword(s):  
Nucleus Tractus Solitarius ◽  
Scientific Evidence ◽  
Brain Structures ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Current View ◽  
Highly Emetogenic Chemotherapy ◽  
Antiemetic Guidelines ◽  
Delayed Nausea ◽  
Physical Consequences

Chemotherapy-induced nausea and vomiting (CINV) has been a major supportive care concern since the development of cisplatin, which was probably the major factor that drove antiemetic research. If strategies, particularly using combination antiemetic therapy, had not been developed and studied, cancer chemotherapy research would also likely to have been stymied. The past 30 years or more have seen our understanding of the physiology of vomiting grow from the understanding of the medullary brain structures we call the chemoreceptor trigger zone and the vomiting center, as well as the neurotransmitters located about that site. The current view of chemotherapy-induced vomiting is that two main pathways are involved—a peripheral pathway from the gut to the vomiting center that is mediated by increased release of serotonin by enterochromaffin cells in the gastrointestinal tract mucosa that binds to vagal terminals terminating in the nucleus tractus solitarius, and a central pathway in the brain that involves substance P binding at neurokinin 1 receptors near the vomiting center. Development of antiemetics that target these specific receptors, plus the use of dexamethasone, has resulted in prevention of acute vomiting in 70–80 % of patients receiving highly emetogenic chemotherapy. The scientific evidence resulting from this antiemetic research, along with clinical application knowledge, forms the basis of current chemotherapy antiemetic guidelines. Although these are useful to clinical practice, they do no replace clinical assessment and follow up of individual patients. Furthermore, about half of patients receiving moderately or highly emetogenic chemotherapy experience distressing delayed nausea, which can alter a patient’s life activities, cause debilitating physical consequences, and interfere with their ability and willingness to undergo chemotherapy.

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.

Meta-analysis of adjunctive non-NK1 antagonist medications for control of acute and delayed nausea and vomiting induced by moderate and highly emetogenic chemotherapy.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. e20670-e20670
Author(s):  
Thaiana Aragão Santana ◽  
Damila Cristina Trufelli ◽  
Felipe Melo Cruz ◽  
Leandro Luongo Matos ◽  
Auro Del Giglio
Keyword(s):  
Meta Analysis ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Highly Emetogenic Chemotherapy ◽  
Delayed Nausea ◽  
Nk1 Antagonist

Olanzapine for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC): Alliance A221301, a randomized, double-blind, placebo-controlled trial.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 176-176 ◽  
Author(s):  
Rudolph M. Navari ◽  
Rui Qin ◽  
Kathryn Jean Ruddy ◽  
Heshan Liu ◽  
Steven Francis Powell ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Controlled Trial ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Secondary Endpoint ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Grade 3

176 Background: The purpose of the study was to determine the effectiveness of olanzapine (OLN) for the prevention of nausea and vomiting in patients receiving highly emetogenic chemotherapy (HEC). Methods: A randomized, double-blind, phase III trial was performed in chemotherapy-naïve patients receiving cisplatin, > 70 mg/m2, or cyclophosphamide-anthracycline-based chemotherapy, comparing OLN to placebo in combination with aprepitant (APR), a 5-HT3 receptor antagonist (5-HT3), and dexamethasone (DEX). The OLN regimen was 10 mg of oral OLN, 125 mg APR, a 5-HT3, and oral DEX 12 mg pre-chemotherapy, day 1, and 10 mg/day of oral OLN and 8 mg DEX on days 2-4 post-chemotherapy plus 80 mg APR on days 2, 3 post-chemotherapy. The placebo (PLA) regimen was oral placebo, pre-chemotherapy, day 1, and on days 2-4 post-chemotherapy; the APR, 5-HT3, and DEX pre- and post-chemotherapy were identical to that used in the OLN regimen. Fosaprepitant (150 mg IV), day 1 was allowed for substitution for the oral aprepitant. Palonosetron, ondansetron, or granisetron were the permitted 5-HT3 options. Nausea was measured on a 0-10 visual analogue scale, with 0 being “no nausea at all” and 10 being “nausea as bad as it can be”. No nausea was the primary endpoint and, complete response (no emesis and no use of rescue medications) was a secondary endpoint. Results: 401 patients (202 OLN, 199 PLA) were enrolled in the study. The proportion of patients who had no nausea was significantly greater for the OLN regimen compared to the PLA regimen for the acute period (24h post-chemotherapy) (74% vs. 45%, p < 0.0006), for the delayed period ( 24-120 h post-chemotherapy) (43% vs. 26%, p < 0.0006), and for the overall period (0-120 h) (39% vs. 22%, p < 0.0006). Complete response was significantly improved for the OLN patients compared to PLA patients for the acute (85% vs. 65%, p < 0.0001), the delayed (67% vs. 53%, p < 0.0078), and the overall periods (64% vs. 41%, p < 0.0001). There were no grade 3 or 4 toxicities. Conclusions: No nausea, the primary endpoint, and complete response, a secondary endpoint, were significantly improved with OLN, compared to PLA. Clinical trial information: NCT02116530.

Preliminary result of phase II study of megestrol combined with 5-hydroxytryptamine 3 inhibitor and dexamethasone for the prevention of nausea and vomiting induced by high emetogenic chemotherapy.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e23049-e23049
Author(s):  
Qiong Wu ◽  
Suxia Luo ◽  
Ning Li ◽  
Wenying Deng ◽  
Yijie Ma ◽  
...  
Keyword(s):  
Side Effects ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Chinese Patients ◽  
Control Group ◽  
Strong Impact ◽  
Antiemetic Regimen ◽  
Antiemetic Guidelines ◽  
Delayed Nausea ◽  
Experimental Group

e23049 Background: Chemotherapy-induced nausea and vomiting (CINV) is one of the most distressing treatment-related side effects and have a strong impact on treatment adherence. A triplet antiemetic regimen, which is composed of neurokinin-1 receptor antagonist (NK1 RA), 5-hydroxytryptamine 3 (5-HT3) inhibitor and dexamethasone, is recommended by current antiemetic guidelines. However, NK1 RA is not available in hospital and more expensive for Chinese patients. Megestrol is currently known as more effective appetite stimulants in patients with cachexia or loss of appetite, but its antiemetic properties are less well known. Therefore, the aim of this study was to further evaluate the efficacy and safety of megestrol for the prevention of CINV. Methods: Patients treated with high emetogenic chemotherapy (HEC) were randomly divided into experimental group and control group. The antiemetic regimen of control group: 5-HT3 inhibitor 5mg/d, dexamethasone 12mg/d1, 8mg/d2-4. The regimen of experimental group: the use of 5-HT3 inhibitor and dexamethasone was the same as that of control group, and each patient took megestrol 160mg orally from the first day of chemotherapy for 10 days. Digestive tract reactions were daily evaluated after beginning of HEC. Primary end point was rate of complete response to vomiting and nausea. Results: From September 7 to December 31, 2018, 60 patients were enrolled and randomized in the study. The delayed nausea and vomiting rates were significantly lower in experimental group than control group (nausea: 63.3% vs 83.3%; vomiting: 13.3% vs 33.3%; p< 0.00). The control group was significantly higher rate of Grade 3-4 vomiting than that of the experimental group (20% vs 0%, p< 0.01). Conclusions: Megestrol, combined with dexamethasone and 5-HT3 inhibitor, has been shown to be able to successfully control CINV and no increase side effects during HEC. Clinical trial information: ChiCTR1800017953. [Table: see text]

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