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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)

Cod-DcDA (Cod-DcDA)

Tamaru Satoshi

Mie University Hospital

2-174 Edobashi, Tsu city, Mie

tamaru3@med.mie-u.ac.jp

Imai Yasuhito

Mie University Hospital

2-174 Edobashi, Tsu city, Mie

+81-592315246

imaiya@med.mie-u.ac.jp

Recruiting

May. 23, 2025

Interventional

single arm study

open(masking not used)

historical control

single assignment

supportive care

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)

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.

Both

advanced cancer

Codonopsis lanceolata 2g/day x 28 days

advanced cancer

Codonopsis lanceolata

D009369

Appetite suppression effect

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)

+81-59-231-5045

Jan. 27, 2025

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