Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo
Primary Purpose
Pancreatic Carcinoma, Adjuvant Chemotherapy, Cancer-related Fatigue
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Codonopsis
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Carcinoma
Eligibility Criteria
Inclusion Criteria: Patients with pancreatic adenocarcinoma was confirmed by pathology after radical resection. Patients received adjuvant chemotherapy after surgery, and the chemotherapy regimen was gemcitabine combined with albumin paclitaxel. ECOG score was less than 2. The expected survival time was more than 3 months. Exclusion Criteria: Patients were received radiotherapy, chemotherapy within 4 weeks. Pregnant and lactating women. Patients were known to be allergic to the regimen.
Sites / Locations
- Zhejiang Provincial People'S HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
intervention
Control group
Arm Description
Codonopsis pilosula Nnannf
Placebo
Outcomes
Primary Outcome Measures
Cancer-related fatigue
The revised Piper fatigue scale (PFS⁃R) was used for accessing Cancer-related fatigue
Secondary Outcome Measures
Immunologic function
Number of T cell subgroups、B cells and NK cells count in plasma were measured every three weeks
Full Information
NCT ID
NCT05613465
First Posted
October 31, 2022
Last Updated
November 10, 2022
Sponsor
Zhejiang Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05613465
Brief Title
Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo
Official Title
A Double-blind, Randomized Controlled Study of Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo After Radical Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Provincial People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pancreatic carcinoma patients got benefit from adjuvant therapy after radical surgery. Gemcitabine combined with albumin-paclitaxel was recommended as the first-line regimen for adjuvant chemotherapy by NCCN guidelines. The most common non-hematological adverse events associated with gemcitabine combined with albumin-paclitaxel treatment were fatigue (54%), followed by alopecia (50%), and grade 3 or higher adverse events were mainly granulocytopenia, leukopenia, fatigue, and peripheral nerve damage. Cancer-related fatigue (CRF) is the most common concomitant symptom in cancer patients, especially during chemotherapy, which has a negative impact on patients' work, social relationships, emotions and daily activities. Therefore, it is of great clinical significance to improve CRF in cancer patients. From the perspective of traditional Chinese medicine, CRF patients will have a series of syndromes such as low function of viscera, general weakness, and emaciation, which last for more than 2 weeks and affect patients' physiology and psychology at the same time. Codonopsis pilosula Nnannf can restore the postoperative immune ability of patients as soon as possible after chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Carcinoma, Adjuvant Chemotherapy, Cancer-related Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
Codonopsis pilosula Nnannf
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Codonopsis
Intervention Description
Codonopsis pilosula Nnannf is oral liquid, which has been approved for listing
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is packaged in the same package as the drug
Primary Outcome Measure Information:
Title
Cancer-related fatigue
Description
The revised Piper fatigue scale (PFS⁃R) was used for accessing Cancer-related fatigue
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Immunologic function
Description
Number of T cell subgroups、B cells and NK cells count in plasma were measured every three weeks
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with pancreatic adenocarcinoma was confirmed by pathology after radical resection.
Patients received adjuvant chemotherapy after surgery, and the chemotherapy regimen was gemcitabine combined with albumin paclitaxel.
ECOG score was less than 2.
The expected survival time was more than 3 months.
Exclusion Criteria:
Patients were received radiotherapy, chemotherapy within 4 weeks.
Pregnant and lactating women.
Patients were known to be allergic to the regimen.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
tao xia
Phone
+8618653268208
Email
taoxiamd@hotmail.com
Facility Information:
Facility Name
Zhejiang Provincial People'S Hospital
City
Hangzhou
State/Province
Other (Non U.s.)
ZIP/Postal Code
314000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tao xia
Phone
+8618653268208
Email
taoxiamd@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo
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