Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo

Zhejiang Provincial People's Hospital

Status: Enrolling

Conditions: Adjuvant Chemotherapy; Cancer-related Fatigue; Pancreatic Carcinoma

Treatments: Drug: Codonopsis; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05613465

ZJPPHGIP-RCT202210

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

intervention

Experimental group

Description:

Codonopsis pilosula Nnannf

Treatment:

Drug: Codonopsis

Control group

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo