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A phase II study evaluating dexamethasone sparing regimen with olanzapine and palonosetron for patients receiving high dose cisplatin to prevent chemotherapy induced nausea and vomiting
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study arm | Experimental | olanzapine palonosetron with dexamethasone on day 1 only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone sparing | Drug | omit dexamethasone on day 2-4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete response rate | no vomiting and no rescue therapy | 5 days after receiving chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| no -nausea rate | no nausea symptom | 5 days after receiving chemotherapy |
| degree of nausea vomiting | grading of nausea vomiting | 5 days after receiving chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suthinee Ithimakin | Contact | +66898127440 | aesi105@yahoo.co.th |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital, Mahidol University | Recruiting | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37973958 | Background | Minatogawa H, Izawa N, Shimomura K, Arioka H, Iihara H, Sugawara M, Morita H, Mochizuki A, Nawata S, Mishima K, Tsuboya A, Miyaji T, Honda K, Yokomizo A, Hashimoto N, Yanagihara T, Endo J, Kawaguchi T, Furuya N, Sone Y, Inada Y, Ohno Y, Katada C, Hida N, Akiyama K, Ichikura D, Konomatsu A, Ogura T, Yamaguchi T, Nakajima TE. Dexamethasone-sparing on days 2-4 with combined palonosetron, neurokinin-1 receptor antagonist, and olanzapine in cisplatin: a randomized phase III trial (SPARED Trial). Br J Cancer. 2024 Feb;130(2):224-232. doi: 10.1038/s41416-023-02493-7. Epub 2023 Nov 16. | |
| 32128615 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| adverse effects | adverse effects | 5 days after receiving chemotherapy |
| rescue therapy | additional treatment for nausea or vomiting | 5 days after chemotherapy |
| Background |
| Ithimakin S, Theeratrakul P, Laocharoenkiat A, Nimmannit A, Akewanlop C, Soparattanapaisarn N, Techawattanawanna S, Korphaisarn K, Danchaivijitr P. Randomized, double-blind, placebo-controlled study of aprepitant versus two dosages of olanzapine with ondansetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving high-emetogenic chemotherapy. Support Care Cancer. 2020 Nov;28(11):5335-5342. doi: 10.1007/s00520-020-05380-6. Epub 2020 Mar 4. |
| 35999527 | Background | Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: results from a randomized phase 3 study. BMC Cancer. 2022 Aug 24;22(1):915. doi: 10.1186/s12885-022-10018-3. |
| 34101934 | Background | Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Dexamethasone-Sparing Regimens with Oral Netupitant and Palonosetron for the Prevention of Emesis Caused by High-Dose Cisplatin: A Randomized Noninferiority Study. Oncologist. 2021 Oct;26(10):e1854-e1861. doi: 10.1002/onco.13851. Epub 2021 Jun 18. |