Exploratory study investigating the efficacy, safety of prophylactic olanzapine for opioid-induced nausea and vomiting in patients with cancer - JORTC-PAL20

开始日期2022-06-03

申办/合作机构-

DRKS00024954 / Recruiting临床2期IIT

PROTREAT-TRIAL PROPHYLACTIC ANTIEMETIC TREATMENT OF OPIOID-INDUCED NAUSEA AND VOMITING (OINV) IN PALLIATIVE CARE: A RANDOMIZED CONTROLLED PHASE II FEASIBILITY TRIAL - ProTreat

开始日期2022-05-13

申办/合作机构-

NCT05315999 / Recruiting临床2期

Protreat-Trial: Prophylactic Antiemetic Treatment of Opioid-induced Nausea and Vomiting (OINV) in Palliative Care: A Randomized Controlled Phase II Feasibility Trial

Palliative cancer patients with tumor pain often suffer from nausea and vomiting when starting pain therapy with opioids. The objective of the clinical pilot trial is to evaluate the efficacy and tolerability of palonosetron in the prophylactic treatment of opioid-induced nausea and vomiting.

开始日期2022-05-03

申办/合作机构-

100 项与药物引起的恶心和呕吐相关的临床结果

登录后查看更多信息

100 项与药物引起的恶心和呕吐相关的转化医学

登录后查看更多信息

0 项与药物引起的恶心和呕吐相关的专利（医药）

登录后查看更多信息

项与药物引起的恶心和呕吐相关的文献（医药）

2024-09-10·Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Naldemedine for Opioid-Induced Constipation in Patients With Cancer: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial.

Article

作者: Doki, Kosuke ; Mathis, Bryan J ; Homma, Masato ; Kobayashi, Yuko ; Hirakawa, Mami ; Tanaka, Kosuke ; Higashibata, Takahiro ; Nakajima, Atsushi ; Jono, Tsumugi ; Ando, Takayuki ; Oyamada, Shunsuke ; Izawa, Naoki ; Takashima, Yasuyuki ; Kasai, Yuki ; Iwaki, Michihiro ; Ariyoshi, Keisuke ; Hayashi, Ryuji ; Yamamoto, Yoshiyuki ; Kajiura, Shinya ; Kessoku, Takaomi ; Ogata, Tomoki ; Horie, Yoshiki ; Fuyuki, Akiko ; Morita, Tatsuya ; Hamano, Jun ; Yamada, Takeshi

PURPOSEOpioid-induced constipation is the most frequent and non-self-limiting adverse effect of opioid analgesia, reducing adherence and interfering with pain relief. This clinical trial aimed to clarify the preventive effect of naldemedine versus placebo for constipation in patients with cancer starting regularly dosed strong opioids therapy.METHODSThis multicenter, double-blinded, randomized, placebo-controlled, confirmatory trial was conducted between July 2021 and May 2023 at four academic hospitals in Japan (ClinicalTrials.gov identifier: jRCTs031200397). Patients with cancer starting a first-time regularly dosed strong opioid for cancer pain and age 20+ years were included. Eligible patients were randomly assigned to the naldemedine (Symproic 0.2 mg) or placebo group in a 1:1 ratio for 14 days with protocol treatment. The primary end point was the proportion of patients with a Bowel Function Index (BFI) of <28.8 on day 14. The secondary end points included frequency of spontaneous bowel movements (SBM), quality of life (QOL), and frequency of opioid-induced nausea and vomiting (OINV).RESULTSOf the 103 patients assessed for eligibility, 99 received either naldemedine (n = 49) or placebo (n = 50). A BFI of <28.8 on day 14 was significantly more likely to occur in the naldemedine group (64.6%; 95% CI, 51.1 to 78.1) versus placebo (17.0%; 95% CI, 6.3 to 27.8), and the difference between groups was 47.6% (95% CI, 30.3 to 64.8; P < .0001). The frequency of SBM, QOL, and the severity of OINV were nominally significant in the naldemedine group than in the control group.CONCLUSIONNaldemedine prevented constipation and improved constipation-related QOL, with possible preventive effect on OINV in patients with cancer starting regularly dosed opioids therapy.

2024-07-01·International Journal of Clinical Oncology

Non-pharmacological treatments for anticipatory nausea and vomiting during chemotherapy: a systematic review and meta-analysis of the Clinical Practice Guidelines for Antiemesis 2023

Review

作者: Wada, Makoto ; Kako, Jun ; Nakamura, Naoki ; Imamura, Chiyo K ; Iino, Keiko ; Matsumoto, Koji ; Sasaki, Hidenori ; Takeda, Masayuki ; Yamamoto, Nobuyuki ; Higashi, Takahiro ; Aogi, Kenjiro ; Hayashi, Kazumi ; Noda, Mayumi ; Okuyama, Ayako ; Kobayashi, Masamitsu ; Okita, Kenji ; Abe, Masakazu ; Kim, Yong-Il ; Akechi, Tatsuo ; Nakajima, Takako Eguchi ; Iihara, Hirotoshi ; Iba, Arisa ; Boku, Narikazu ; Satomi, Eriko ; Tanaka, Ryuhei ; Ozawa, Keiko ; Matsumoto, Yoko ; Nishimura, Junichi

BACKGROUNDAnticipatory chemotherapy-induced nausea and vomiting (CINV) is a conditioned response influenced by the severity and duration of previous emetic responses to chemotherapy. We aimed to evaluate the efficacy of non-pharmacologic interventions for anticipatory CINV among patients with cancer.METHODSWe conducted a systematic search in databases, including PubMed, the Cochrane Library, CINAHL, and Ichushi-Web, from January 1, 1990, to December 31, 2020. Randomized controlled trials, non-randomized designs, observational studies, or case-control studies that utilized non-pharmacological therapies were included. The primary outcomes were anticipatory CINV, with an additional investigation into adverse events and the costs of therapies. The risk-of-bias for each study was assessed using the Cochrane risk-of-bias tool, and meta-analysis was performed using Revman 5.4 software.RESULTSOf the 107 studies identified, six met the inclusion criteria. Three types of non-pharmacological treatments were identified: systematic desensitization (n = 2), hypnotherapy (n = 2), and yoga therapy (n = 2). Among them, systematic desensitization significantly improved anticipatory CINV as compared to that in the control group (nausea: risk ratio [RR] = 0.60, 95% confidence interval [CI] = 0.49-0.72, p < 0.00001; vomiting: RR = 0.54, 95% CI = 0.32-0.91, p = 0.02). However, heterogeneity in outcome measures precluded meta-analysis for hypnotherapy and yoga. Additionally, most selected studies had a high or unclear risk of bias, and adverse events were not consistently reported.CONCLUSIONSOur findings suggest that systematic desensitization may effectively reduce anticipatory CINV. However, further research is warranted before implementation in clinical settings.

2024-07-01·Supportive Care in Cancer

Pharmacological treatment of cancer pain and opioid induced nausea and vomiting: online survey and comparison with current guidelines

Article

作者: Roch, Carmen ; Boehlke, Christopher ; Mueller, Evelyn ; Gaertner, Jan ; Kreye, Gudrun ; Fusi-Schmidhauser, Tanja

AbstractPurposeWe assumed that in Palliative Care, even in common clinical situations, the choice of drugs differs substantially between physicians. Therefore, we assessed the practice of pharmaceutical treatment choices of physicians for cancer pain and opioid-induced nausea and vomiting (OINV) and the rationale for their choices.MethodsAn online survey was conducted with physicians covering the following domains: i) Cancer pain therapy: non-opioids in addition to opioids: choice of drug ii) prevention of OINV: choice of drug and mode of application. Current guidelines concerning cancer pain therapy and prevention of OINV were compared.ResultsTwo-hundred-forty European physicians responded to our survey. i) Use of non-opioids in addition to opioids for the treatment of cancer pain: Only 1.3% (n = 3) of respondents never used an additional non-opioid. Others mostly used: dipyrone/metamizole (49.2%, n = 118), paracetamol/acetaminophen (34.2%, n = 82), ibuprofen / other NSAIDs (11.3%, n = 27), specific Cox2-inhibitors (2.1%, n = 5), Aspirin (0.4%, n = 1), no answer (2.9%, n = 7). ii) Antiemetics to prevent OINV: The drugs of choice were metoclopramide (58.3%, n = 140), haloperidol (26.3%, n = 63), 5-HT3 antagonists (9.6%, n = 23), antihistamines (1.3%, n = 3) and other (2.9%, n = 7); no answer (1.7%, n = 4). Most respondents prescribed the substances on-demand (59.6%, n = 143) while others (36.3%, n = 87) provided them as around the clock medication. Over both domains, most physicians answered that their choices were not based on solid evidence from randomized controlled trials (RCTs). Guidelines were inconsistent regarding if and what non-opioid to use for cancer pain and recommend anti-dopaminergic drugs for prevention or treatment of OINV.ConclusionsPhysician’s practice in palliative care for the treatment of cancer pain and OINV differed substantially. Respondents expressed the lack of high-quality evidence- based information from RCTs. We call for evidence from methodologically high-quality RCTs to be available to inform physicians about the benefits and harms of pharmacological treatments for common symptoms in palliative care.