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Clinical Trials/jRCTs041250035
jRCTs041250035RecruitingNot Applicable

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)

Not provided0 sites50 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
50
Primary Endpoint
-
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Single Arm Study
Intervention Model
Single Assignment
Primary Purpose
Supportive Care
Masking
Open(masking Not Used)

Eligibility Criteria

Ages
18age old over to No limit (—)
Sex
All

Inclusion Criteria

  • •Patients 18 years of age or older with advanced cancer undergoing chemotherapy, receiving palliative care, or being treated in a hospice.
  • •Patients who have given their free written consent to participate in this study after obtaining full informed consent.
  • •Patients with an ECOG-PS of 0 to 2
  • •Patients without severe allergic diseases (including severe asthma, urticaria, angioedema, chronic allergic rhinitis of long standing, etc.)
  • •Patients who are expected to survive for at least 3 months
  • •Patients who are able to eat and drink on their own (patients who do not require assistance or support)

Exclusion Criteria

  • •Patients who are unable to perform swallowing exercises.
  • •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.
  • •Patients who are judged by the principal investigator or subinvestigator to be inappropriate to participate in this study.

Outcomes

Primary Outcomes

-

Appetite suppression effect

Secondary Outcomes

  • Inhibition of appetite loss(Day 15 and Day 22)
  • Nausea and vomiting(Day15 and Day22)
  • Malaise(Day15 and Day22)
  • Percentage increase or decrease in food intake compared to Baseline
  • Percentage change in skin blood flow (improvement in blood flow)
  • Bowel movements (improvement in frequency of bowel movements, etc.)
  • Occurrence of nausea and vomiting(24-120 hours after completion of chemotherapy)

Investigators

Sponsor
Not provided

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