Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo

Study Overview

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.

N/A

Pancreatic Carcinoma
Adjuvant Chemotherapy
Cancer-related Fatigue

DRUG: Codonopsis
DRUG: Placebo

ZJPPHGIP-RCT202210

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-10-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-11-10
First Submitted that Met QC Criteria 2022-11-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-11-14
First Posted (ACTUAL) 2022-11-14	Results First Posted N/A	Last Verified 2022-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Double

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: intervention Codonopsis pilosula Nnannf	DRUG: Codonopsis Codonopsis pilosula Nnannf is oral liquid, which has been approved for listing
PLACEBO_COMPARATOR: Control group Placebo	DRUG: Placebo Placebo is packaged in the same package as the drug

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: intervention

Codonopsis pilosula Nnannf

DRUG: Codonopsis

Codonopsis pilosula Nnannf is oral liquid, which has been approved for listing

PLACEBO_COMPARATOR: Control group

Placebo

DRUG: Placebo

Placebo is packaged in the same package as the drug

Primary Outcome Measures	Measure Description	Time Frame
Cancer-related fatigue	The revised Piper fatigue scale (PFS⁃R) was used for accessing Cancer-related fatigue	9 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Immunologic function	Number of T cell subgroups、B cells and NK cells count in plasma were measured every three weeks	9 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: tao xia

Phone Number: +8618653268208

Email: taoxiamd@hotmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

Patients were received radiotherapy, chemotherapy within 4 weeks.
Pregnant and lactating women.
Patients were known to be allergic to the regimen.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Resources

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Clinical Trial Record