CClinicalTrials.gg
Status unknownNCT05613465Updated Nov 14, 2022

Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo

An interventional study of Codonopsis and Placebo in Pancreatic Carcinoma, Adjuvant Chemotherapy and Cancer-related Fatigue, sponsored by Zhejiang Provincial People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-11-14.

Sponsored by Zhejiang Provincial People's Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pancreatic Carcinoma
  • Adjuvant Chemotherapy
  • Cancer-related Fatigue
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 100 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Zhejiang Provincial People's Hospital is the lead sponsor of 60 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    intervention

    Codonopsis pilosula Nnannf

    Drug: Codonopsis

  • Placebo comparator
    Control group

    Placebo

    Drug: Placebo

Interventions

  • DrugCodonopsis

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

  • DrugPlacebo

    Placebo is packaged in the same package as the drug

06

What researchers measure

Primary outcomes

  1. Cancer-related fatigue

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

    Time frame: 9 weeks

Secondary outcomes

  1. Immunologic function

    Number of T cell subgroups、B cells and NK cells count in plasma were measured every three weeks

    Time frame: 9 weeks

07

Study locations

1 of 1 sites recruiting
  • Zhejiang Provincial People'S Hospital
    Hangzhou, Other (Non U.s.) 314000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05613465
Lead sponsor
Zhejiang Provincial People's Hospital
Responsible party
Sponsor
First posted
Nov 14, 2022
Start date
Oct 25, 2022
Primary completion
Oct 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Nov 14, 2022

Study contacts

tao xia
Contact
taoxiamd@hotmail.com
+8618653268208

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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