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

Prospective observational study to evaluate the efficacy of fosnetupitant for long delayed chemotherapy-induced nausea and vomiting in patients recieving platinam-based chemotherapy (LODEC-N) - Long delayed emesis induced by cancer chemotherapy can be suppressed by NK1 receptor antagonist (LODEC-N)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030230130

Enrollment

100

Registered

2023-06-12

Start date

2023-06-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

antineoplastic combined chemotherapy regimens Cancer chemotherapy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
long delayed (120-336 hours) complete control rate of chemotherapy rejimen in first cycle of chemotherapy	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactIimura Yohei

The IMSUT Hospital, The Institute of Medical Science, The University of Tokyo

youhei0519@g.ecc.u-tokyo.ac.jp+81-3-3443-8111

Outcome results