Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo

Not Applicable

Recruiting

• Conditions: Adjuvant Chemotherapy; Pancreatic Carcinoma; Cancer-related Fatigue
• Interventions: Drug: Codonopsis; Drug: Placebo

• Registration Number: NCT05613465
• Lead Sponsor: Zhejiang Provincial People's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-25
• Study First Submitted: 2022-10-31
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-10
• Last Update Submitted: 2022-11-10
• Study First Posted: 2022-11-14
• Last Update Posted: 2022-11-14
• Primary Completion: 2024-10-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Codonopsis	Codonopsis pilosula Nnannf
Control group	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Cancer-related fatigue	9 weeks	The revised Piper fatigue scale (PFS⁃R) was used for accessing Cancer-related fatigue

Secondary Outcome Measures

Name	Time	Method
Immunologic function	9 weeks	Number of T cell subgroups、B cells and NK cells count in plasma were measured every three weeks

Trial Locations

Locations (1)

Zhejiang Provincial People'S Hospital; 🇨🇳 Hangzhou, Other (Non U.s.), China