UMIN-CTR Clinical Trial

Basic information
Public title	The HGCSG1902 Study; An investigator-initiated, multicenter, prospective observational study on cases of dysgeusia caused by chemotherapy for gastroenterological cancer
Acronym	HGCSG1902
Scientific Title	The HGCSG1902 Study; An investigator-initiated, multicenter, prospective observational study on cases of dysgeusia caused by chemotherapy for gastroenterological cancer
Scientific Title:Acronym	HGCSG1902
Region	Japan

Condition
Condition	gastroenterological cancer
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To measure multiple factors related to dysgeusia in patients with chemotherapy for gastroenterological cancer, and examine the measured values, transitions, and correlations of each factor with treatment effects.
Basic objectives2	Others
Basic objectives -Others	To measure multiple factors related to dysgeusia in patients with chemotherapy for gastroenterological cancer, and examine the measured values, transitions, and correlations of each factor with treatment effects.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in taste disorders
Key secondary outcomes	Relationship between serum zinc level and taste disorder, involvement of physical factors (age, height, weight, body surface area), involvement of nutritional factors (hemoglobin level, serum iron, albumin level), safety of drugs used

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	1.Patients who are treated with chemotherapy in gastroenterological cancer. 2.Age <=20 years old at the time of registration. 3.Patients with ECOG Performance Status (PS) 0-2. 4.Patients whose dysgeusia is Grade 1 or higher according to Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0) or Grade 1 or higher according to Scale of Subjective Total Taste Acuity (STTA), and who has not been treated for dysgeusia. 5.Patients who are denied other diseases that cause taste disorder. 6.Patients expected to survive for at least 12 weeks from the date of registration. 7.Patients who can take orally. 8.Patients who have given written informed consent to participate in the study.
Key exclusion criteria	1.Patients with serious complications (heart failure, liver failure, renal failure, active gastrointestinal ulcer, intestinal paralysis, etc.) 2.Patients with clinically significant mental or central nervous system disorders. 3.Patients with a history of head and neck radiation therapy. 4.Women who are pregnant or may become pregnant. Lactating woman. 5.Patients already taking zinc-containing preparations (including supplements) 6.Patients who are allergic to zinc-containing preparations. 7.Patients planning to finish chemotherapy within 12 weeks. 8.Patients whose physician predicts that it is difficult to continue chemotherapy for more than 12 weeks. 9.Participation in the clinical trial is determined as unsuitable.
Target sample size	180

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	Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL	011-716-1161
Email	ykomatsu@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Ken Middle name Last name Ito
Organization	Hokkaido University Hospital
Division name	Cancer Center
Zip code	060-8648
Address	Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL	011-716-1161
Homepage URL
Email	kenito0421@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido Gastrointestinal Cancer Study Group
Institute
Department

Funding Source
Organization	Hokkaido Gastrointestinal Cancer Study Group
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research and Medical Innovation Center, Hokkaido University Hospital
Address	Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel	011-706-7636
Email	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	NTT東日本札幌病院（北海道）、愛育病院（北海道）、市立函館病院（北海道）、釧路ろうさい病院（北海道）、伊達赤十字病院（北海道）、手稲渓仁会病院（北海道）、富山赤十字病院（富山県）、富山大学病院（富山県）、北海道医療センター（北海道）、北海道消化器科病院（北海道）

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 02 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	180
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	2019 Year 12 Month 28 Day
Date of IRB	2020 Year 02 Month 21 Day
Anticipated trial start date	2020 Year 03 Month 02 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The data to be collected in this study include changes in taste dysfunction, the relationship between serum zinc levels and taste dysfunction, the contribution of physical factors to taste dysfunction (age, height, weight, body surface area), and the involvement of nutritional factors ( Hemoglobin level, serum iron, albumin level) and the safety of the drug used.

Management information
Registered date	2020 Year 03 Month 01 Day
Last modified on	2022 Year 03 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044981