Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo

NCT05613465 | Unknown DMC

• 1 other identifier: ZJPPHGIP-RCT202210
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Carcinoma; Adjuvant Chemotherapy; Cancer-related Fatigue

Outcome Measures

Primary Outcomes (1)

• Cancer-related fatigue

  The revised Piper fatigue scale (PFS⁃R) was used for accessing Cancer-related fatigue

  9 weeks

Secondary Outcomes (1)

• Immunologic function

  9 weeks

Study Arms (2)

intervention

EXPERIMENTAL

Codonopsis pilosula Nnannf

Drug: Codonopsis

Control group

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Codonopsis DRUG

Codonopsis pilosula Nnannf is oral liquid, which has been approved for listing

intervention

Placebo DRUG

Placebo is packaged in the same package as the drug

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients were received radiotherapy, chemotherapy within 4 weeks.
• Pregnant and lactating women.
• Patients were known to be allergic to the regimen.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang Provincial People'S Hospital

Hangzhou, Other (Non U.s.), 314000, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

tao xia

CONTACT

+8618653268208; taoxiamd@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 14, 2022
• Study Start: October 25, 2022
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

CN (1)