Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-25

Study Completion Date

2024-12-30

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.

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Detailed Description

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Conditions

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Pancreatic Carcinoma Adjuvant Chemotherapy Cancer-related Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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intervention

Codonopsis pilosula Nnannf

Group Type EXPERIMENTAL

Codonopsis

Intervention Type DRUG

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

Control group

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo is packaged in the same package as the drug

Interventions

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Codonopsis

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

Intervention Type DRUG

Placebo

Placebo is packaged in the same package as the drug

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No