Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo

Study Overview
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Brief Summary
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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.

Official Title
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A Double-blind, Randomized Controlled Study of Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo After Radical Surgery

Conditions
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Pancreatic Carcinoma, Adjuvant Chemotherapy, Cancer-related Fatigue

Intervention / Treatment
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* Drug: Codonopsis
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>Codonopsis pilosula Nnannf | Drug: Codonopsis<br>* Codonopsis pilosula Nnannf is oral liquid, which has been approved for listing<br>|
| Placebo Comparator: Control group<br>Placebo | Drug: Placebo<br>* Placebo is packaged in the same package as the drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 |