Long delayed emesis induced by cancer chemotherapy can be suppressed by NK1 receptor antagonist (LODEC-N)

JRCT ID: jRCT1030230130

Registered date:12/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: antineoplastic combined chemotherapy regimens
• Date of first enrollment: 12/06/2023
• Target sample size: 100
• Study type: Observational

Outcome(s)

• Primary Outcome: long delayed (120-336 hours) complete control rate of chemotherapy rejimen in first cycle of chemotherapy

Secondary Outcome

The following items up to 336 hours after the start of cancer chemotherapy in first cycle of chemotherapy
(i) complete response rate
(ii) total control rate
(iii) frequency of chemotherapy induced vomiting
(iv) grade of chemotherapy induced vomiting
(v) frequency of chemotherapy induced nausea
(vi) grade of chemotherapy induced nausea
(vii) time of onset of chemotherapy induced vomiting
(viii) time of onset of chemotherapy induced nausea
(ix) the risk factors that caused complete control not to be achieved
The following items up to 336 hours after the start of cancer chemotherapy after second cycle of chemotherapy
(x) complete response rate
(xi) total control rate
(xii) frequency of chemotherapy induced vomiting
(xiii) grade of chemotherapy induced vomiting
(xiv) frequency of chemotherapy induced nausea
(xv) grade of chemotherapy induced nausea
(xvi) time of onset of chemotherapy induced vomiting
(xvii) time of onset of chemotherapy induced nausea
(xviii) frequency of chemotherapy induced anorexia
(xix) grade of chemotherapy induced anorexia

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(i) written informed consent to participate in this study
(ii) patients undergoing chemotherapy and administered standard antiemetic therapy
(iii) age >18 years
(iv) male or female
(v) Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1

Exclude criteria

(i) administration of low or minimal emetic risk rejimen
(ii) the use of opioids
(iii) patients with a history of habitual vomiting
(iv) brain metastasis having uncontrollable symptoms
(v) current radio therapy (within three months)
(vi) administration of chemotherapy within three months before enrolment
(vii) experienced nausea and vomiting within one week before enrollment
(viii) the current use of antiemetic agents within two week before enrollment
(ix) pregnant and lactating women

Related Information

• Primary Sponsor: Seiichiro Kuroda