The prospective study of relation between 5-HIAA/substance P and nausea/vomiting in patients who receiving moderately emetogenic chemotherapy

The prospective study of relation between 5-HIAA/substance P and nausea/vomiting in patients who receiving moderately emetogenic chemotherapy - The prospective study of relation between 5-HIAA/substance P and nausea/vomiting in patients who receiving moderately emetogenic chemotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000021072

Enrollment

Registered

2016-02-18

Start date

2016-02-18

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

esophagogastrointestinal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: written informed consent. 20 years of age or older. Pathologically diagnosed esophageal, gastric or colorectal carcinoma. patients planned to receive more than 60mg/m2 cisplatin, or patients planned to receive oxaliplatin or irinotecan. ECOG PS of 0, 1 or 2. adequate organ functions as follows, a. neutrophil count is 1,500/mm3 or more b. platelet count is 100,000/mm3 or more c. ALT is 2.5 times or less of the facility reference value upper limit. d. total bilirubin is 1.5 times or less of the facility reference value upper limit. e. serum creatinine is 1.5 times or less of the facility reference value upper limit.

Exclusion criteria

Exclusion criteria: using antiemetics within 48 hours except for prevention from chemotherapy-induced nausea and vomiting. cannot eat by mouth. using more than 10mg/m2 corticosteroids within 72 hours except for prevention from chemotherapy-induced nausea and vomiting. clarified brain metastasis. nausea and vomiting within 24 hours before receiving chemotherapy. pregnant or lactating women. with uncontrolable infection or diabetes mellitus. allergy for 5HT receptor blocker or aprepitant. can not cooperate with the blood collection

Design outcomes

Primary

Measure	Time frame
Relevance of blood substance P concentration and the VAS (visual analogue scale) of nausea of anti-cancer drugs administered before and after the rate of change and the anti-cancer agent 24-120 hours after administration ( late-onset nausea )	—

Secondary

Measure	Time frame
Relevance of change of blood 5-HIAA / substance P concentration to visual analogue scale ( VAS )of nausea 24-120 hours after anti-cancer drug administration ( late-onset nausea ). Relevance of change of blood 5-HIAA / substance P concentration to vomiting 24-120 hours after anti-cancer drug administration ( late-onset vomiting ). Relevance of change of blood 5-HIAA / substance P concentration to visual analogue scale ( VAS ) of nausea 0-24 hours after anti-cancer drug administration ( early-onset nausea ). Relevance of blood 5-HIAA / substance P concentration to early-onset nausea and vomiting. Relevance of blood 5-HIAA / substance P concentration to late-onset nausea and vomiting. Comparison between blood 5-HIAA / substance P concentration of patients with and without complete response (no emetic episodes and no rescue therapy). Comparison between blood 5-HIAA / substance P concentration of patients with and without complete control (no emetic episodes, no rescue therapy, and no nausea) Transition of blood 5-HIAA / substance P concentration of patients receiving moderately emetogenic chemotherapy.	—

Measure

Time frame

Relevance of change of blood 5-HIAA / substance P concentration to visual analogue scale ( VAS )of nausea 24-120 hours after anti-cancer drug administration ( late-onset nausea ). Relevance of change of blood 5-HIAA / substance P concentration to vomiting 24-120 hours after anti-cancer drug administration ( late-onset vomiting ). Relevance of change of blood 5-HIAA / substance P concentration to visual analogue scale ( VAS ) of nausea 0-24 hours after anti-cancer drug administration ( early-onset nausea ). Relevance of blood 5-HIAA / substance P concentration to early-onset nausea and vomiting. Relevance of blood 5-HIAA / substance P concentration to late-onset nausea and vomiting. Comparison between blood 5-HIAA / substance P concentration of patients with and without complete response (no emetic episodes and no rescue therapy). Comparison between blood 5-HIAA / substance P concentration of patients with and without complete control (no emetic episodes, no rescue therapy, and no nausea) Transition of blood 5-HIAA / substance P concentration of patients receiving moderately emetogenic chemotherapy.

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Countries

Japan

Contacts

Public ContactTetsuhito Muranaka

Hokkaido University Hospital Cancer Center

tmuranaka@med.hokudai.ac.jp011-716-1161

Outcome results