CompletedPhase 4

Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk)

China, Czechia414 participantsStarted 2021-02-01

Plain-language summary

MyRisk: Efficacy and safety evaluation of oral Akynzeo® in patients receiving MEC at high risk of developing CINV based on a prediction tool. A multinational and multicenter study. Antiemetic guidelines recommendations are based on the emetogenic potential of the chemotherapy. Chemotherapy (CT) agents are divided in Highly, Moderately, Low and Minimally Emetogenic potential. In addition to type of chemotherapy, several patient-related risk factors can increase the risk of CINV (chemotherapy-induced nausea and vomiting). Currently, there is limited consensus surrounding the most relevant patient risk factors that may predict the risk of CINV. Based on a recent study by Dranitsaris et al. (Dranitsaris et al. Ann Oncol. 2017 Jun 1; 28(6):1260-1267.), eight (8) predictive factors have been identified and an algorithm has been developed to incorporate these factors into the optimal selection of prophylactic antiemetics: 1. nausea and/or vomiting in the prior cycle of chemotherapy 2. use of non-prescribed antiemetics at home in the prior cycle of chemotherapy 3. platinum or anthracycline-based chemotherapy 4. age \< 60 years 5. expectations for (anticipating) nausea and/or vomiting 6. \<7 h of sleep the night before chemotherapy 7. history of morning sickness during previous pregnancy 8. cycle of chemotherapy (A negative association between risk and number of cycles was identified where the hazard for CINV was highest in cycles 1 and 2, with a gradual decline and plateau from cycle 3 onward). The clinical application of this prediction tool has the potential to be an important resource for clinicians and may help to enhance patient care by optimizing the use of the antiemetics in a proactive manner.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Adult patients aged ≥18 years * Patients with a risk score of ≥ 13 as calculated by the algorithm - see 3.6.3.1. Baseline/screening: VISIT 0 * Signed Informed consent * Both sexes * Patients with diagnosis of any cancer scheduled and intended to be treated for three consecutive cycles with a single dose of any IV MEC regimen, per cycle, including adjuvant or neo-adjuvant chemotherapy * Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * Use of Standard of Care defined as a 5-HT3 RA + Dexamethasone (or equivalent corticosteroid) based-regimen on day 1 of chemotherapy for CINV prevention * Naïve and non- naïve to chemotherapy * The enrolled women should be a) of non-childbearing potential or b) of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test done by health care team within 1-24 hours before dosing the antiemetic treatment in both arms and outcome recorded in the medical records * Able to comply with study requirements Exclusion Criteria: * Patients receiving highly emetogenic chemotherapy (including anthracycline+cyclophosphamide-based chemotherapy) * Patients receiving oral moderately emetogenic chemotherapy drugs * Patients receiving opioids within 2 weeks prior to trial enrollment (longer use allowed) * Use of olanzapine as prophylaxis of CINV * Patients scheduled to receive radiotherapy concurrently with chemotherapy * Any illness or condition that, in the …

What they're measuring

The Probability of Complete Responses Over Three Cycles of Chemotherapy After the Start of the MEC Administration

Timeframe: At the end of all three chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

Trial details

NCT IDNCT04817189

SponsorHelsinn Healthcare SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-02

Results submitted2025-06-27