臨床研究等提出・公開システム

Japanese

Date of registration	May. 23, 2025
Last modified on	July. 31, 2025
Trial ID	jRCTs041250035

Scientific Title	An exploratory study of the palliative effect of Codonopsis lanceolata on symptoms such as decreased appetite, nausea and vomiting and fatigue in patients with advanced cancer. (Cod-DcDA)
Public Title	Cod-DcDA (Cod-DcDA)

Contact for Scientific Queries	Name	Tamaru Satoshi
	Affiliation	Mie University Hospital
	Address	2-174 Edobashi, Tsu city, Mie
	Telephone	+81-592315246
	E-mail	tamaru3@med.mie-u.ac.jp
Contact for Public Queries	Name	Imai Yasuhito
	Affiliation	Mie University Hospital
	Address	2-174 Edobashi, Tsu city, Mie
	Telephone	+81-592315246
	E-mail	imaiya@med.mie-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 23, 2025
Actual date of first enrollment
Target sample size		50
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	historical control
	assignment	single assignment
	purpose	supportive care
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients 18 years of age or older with advanced cancer undergoing chemotherapy, receiving palliative care, or being treated in a hospice. 2) Patients who have given their free written consent to participate in this study after obtaining full informed consent. 3) Patients with an ECOG-PS of 0 to 2 4) Patients without severe allergic diseases (including severe asthma, urticaria, angioedema, chronic allergic rhinitis of long standing, etc.) 5) Patients who are expected to survive for at least 3 months 6) Patients who are able to eat and drink on their own (patients who do not require assistance or support)
	Exclusion Criteria	1) Patients who are unable to perform swallowing exercises. 2) Patients with cancer who have a treatment plan other than chemotherapy (surgery, radiotherapy, etc.) from 28 days prior to the start of this study to the end of the study. 3) Patients who are judged by the principal investigator or subinvestigator to be inappropriate to participate in this study.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		advanced cancer
Intervention(s)		Codonopsis lanceolata 2g/day x 28 days
Health Condition(s) Keyword		advanced cancer
Intervention(s) Keyword		Codonopsis lanceolata
Health Condition(s) Code		D009369
Intervention(s) Code
Primary Outcome(s)		Appetite suppression effect
Secondary Outcome(s)		1) Inhibition of appetite loss at Day 15 in patients with advanced cancer for whom the study subjects are receiving chemotherapy. 2) Inhibition of appetite loss at Day 15 and Day 22 in patients receiving palliative care or being treated in a hospice. 3) Nausea and vomiting at Day15 and Day22 4) Malaise at Day15 and Day22 5) Percentage increase or decrease in food intake compared to Baseline 6) Percentage change in skin blood flow (improvement in blood flow) if study subjects are advanced cancer patients receiving chemotherapy 7) Bowel movements (improvement in frequency of bowel movements, etc.) 8) Occurrence of nausea and vomiting 24-120 hours after completion of chemotherapy, use of antiemetic drugs (rescue drugs)

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Mie University hospital clinical research scholarship
Secondary Sponsor	Not applicable

Name of Certified Review Board	Mie University Hospital Clinical Research Review Board
Address	2-174 Edobashi, Tsu city, Mie, Mie
Telephone	+81-59-231-5045
E-Mail	mie-crb@mo.medic.mie-u.ac.jp
Approval Status	Approval
Date of approval	Jan. 27, 2025

Plan to share IPD	No
Plan description	None

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	None

History of Changes

No	Publication date
2	July. 31, 2025	(this page)	Changes
1	May. 23, 2025	Detail

List of change history