Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo

Pancreatic Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613465
• Other study ID #: ZJPPHGIP-RCT202210
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2022
• Source: Zhejiang Provincial People's Hospital
• Contact: tao xia
• Phone: +8618653268208
• Email: taoxiamd[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adjuvant Chemotherapy
• Cancer-related Fatigue
• Pancreatic Carcinoma
• Pancreatic Neoplasms

Intervention

Drug:
• Codonopsis
Codonopsis pilosula Nnannf is oral liquid, which has been approved for listing
• Placebo
Placebo is packaged in the same package as the drug

Locations

Country	Name	City	State
China	Zhejiang Provincial People'S Hospital	Hangzhou	Other (Non U.s.)

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer-related fatigue	The revised Piper fatigue scale (PFS?R) was used for accessing Cancer-related fatigue	9 weeks
Secondary	Immunologic function	Number of T cell subgroups?B cells and NK cells count in plasma were measured every three weeks	9 weeks