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Trial Title:
Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo
NCT ID:
NCT05613465
Condition:
Pancreatic Carcinoma
Adjuvant Chemotherapy
Cancer-related Fatigue
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Codonopsis
Description:
Codonopsis pilosula Nnannf is oral liquid, which has been approved for listing
Arm group label:
intervention
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo is packaged in the same package as the drug
Arm group label:
Control group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Provincial People'S Hospital
Address:
City:
Hangzhou
Zip:
314000
Country:
China
Status:
Recruiting
Contact:
Last name:
tao xia
Phone:
+8618653268208
Email:
taoxiamd@hotmail.com
Start date:
October 25, 2022
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Zhejiang Provincial People's Hospital
Agency class:
Other
Source:
Zhejiang Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05613465
