NCT05613465

Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Zhejiang Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Carcinoma
• Adjuvant Chemotherapy
• Cancer-related Fatigue

Interventions

Type	Name	Description
DRUG	Codonopsis	Codonopsis pilosula Nnannf is oral liquid, which has been approved for listing
DRUG	Placebo	Placebo is packaged in the same package as the drug

Timeline

• Start date: 2022-10-25
• Primary completion: 2024-10-30
• Completion: 2024-12-30
• First posted: 2022-11-14
• Last updated: 2022-11-14

Locations

1 site across 1 country: China