JRCT ID: jRCTs041250035
Registered date:23/05/2025
Cod-DcDA
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | advanced cancer |
| Date of first enrollment | 15/10/2025 |
| Target sample size | 50 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Codonopsis lanceolata 2g/day x 28 days |
Outcome(s)
| Primary Outcome | Appetite suppression effect |
|---|---|
| Secondary Outcome | 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) |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include 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) |
| Exclude 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. |
Related Information
| Primary Sponsor | Tamaru Satoshi |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Mie University hospital clinical research scholarship |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Yasuhito Imai |
| Address | 2-174 Edobashi, Tsu city, Mie Mie Japan 5148507 |
| Telephone | +81-592315246 |
| imaiya@med.mie-u.ac.jp | |
| Affiliation | Mie University Hospital |
| Scientific contact | |
| Name | Satoshi Tamaru |
| Address | 2-174 Edobashi, Tsu city, Mie Mie Japan 5148507 |
| Telephone | +81-592315246 |
| tamaru3@med.mie-u.ac.jp | |
| Affiliation | Mie University Hospital |