UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021072 |
|---|---|
| Receipt number | R000024303 |
| Scientific Title | The prospective study of relation between 5-HIAA/substance P and nausea/vomiting in patients who receiving moderately emetogenic chemotherapy |
| Date of disclosure of the study information | 2016/02/18 |
| Last modified on | 2020/03/05 19:06:24 |
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Basic information
Public title
The prospective study of relation between 5-HIAA/substance P and nausea/vomiting in patients who receiving moderately emetogenic chemotherapy
Acronym
The prospective study of relation between 5-HIAA/substance P and nausea/vomiting in patients who receiving moderately emetogenic chemotherapy
Scientific Title
The prospective study of relation between 5-HIAA/substance P and nausea/vomiting in patients who receiving moderately emetogenic chemotherapy
Scientific Title:Acronym
The prospective study of relation between 5-HIAA/substance P and nausea/vomiting in patients who receiving moderately emetogenic chemotherapy
Region
| Japan |
Condition
Condition
esophagogastrointestinal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to clarify relevance between 5-HIAA/substance P and nausea/vomiting in patients who receiving moderately emetogenic chemotherapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
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 )
Key secondary outcomes
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Yoshito |
| Middle name | |
| Last name | Komatsu |
Organization
Hokkaido University Hospital
Division name
Cancer Center
Zip code
060-8648
Address
Hokkaido University Hospital Cancer Center, Hokkaido University Hospital, Kita-14-Jyou Nishi-5-Choume, Kita-ku, Sapporo-City, Hokkaido, Japan
TEL
011-716-1161
ykomatsu@ac.cyberhome.ne.jp
Public contact
Name of contact person
| 1st name | Tetsuhito |
| Middle name | |
| Last name | Muranaka |
Organization
Hokkaido University Hospital
Division name
Cancer Center
Zip code
060-8648
Address
Kita-14-Jyou Nishi-5-Choume, Kita-ku, Sapporo-City, Hokkaido, Japan
TEL
011-716-1161
Homepage URL
tmuranaka@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital Cancer Center
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
HOKKAIDO GASTROINTESTINAL CANCER STUDY GROUP
IRB Contact (For public release)
Organization
Clinical Research and Medical Innovation Center, Hokkaido University Hospital
Address
Kita-15, Nishi-5, Kita-Ku, Sapporo City, Hokkaido, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道大学病院（北海道）、市立札幌病院（北海道）、釧路労災病院（北海道）、NTT東日本札幌病院（北海道）、苫小牧日翔病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 09 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 09 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
This trial is prospective observational study.
From February 18, 2016 to October 31, 2017 in patients who visited the research facilities, incorporate all that meet the selection criteria.
We measure these items using patients' blood as follows; hemoglobin, white blood cell count, differential leukocyte count, platelet count, AST, ALT, LDH, total protein, albumin, BUN, creatinine, CRP, CEA, 5-HIAA, substance P.
Nausea and vomiting information is collected using a patient diary .
Blood 5-HIAA is outsourced to SRL or BML.
Blood substance P is measured in Kyowa Medics KM Assay Center.
Management information
Registered date
| 2016 | Year | 02 | Month | 17 | Day |
Last modified on
| 2020 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024303
| Research Plan | |
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