NCT06598033

Brief Summary

The purpose of this study is to evaluate the efficacy of vitamin C plus herbal medicine in improving the quality of life for metastatic pancreatic cancer patients who are resistant to chemotherapy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 pancreatic-cancer

Timeline
17mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Nov 2024Oct 2027

First Submitted

Initial submission to the registry

September 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 22, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

November 26, 2024

Status Verified

September 1, 2024

Enrollment Period

1.9 years

First QC Date

September 11, 2024

Last Update Submit

November 22, 2024

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Quality of life (QOL) questionnaire

    Change of QOL after every cycle of treatment using ORTC QLQ-C30 (version 3). Scale 1-7, higher scores mean a better outcome.

    1 month

Secondary Outcomes (4)

  • Rate of hand-foot skin reaction, HFSR

    1 month

  • Rate of anemia

    1 month

  • Overall survival，OS

    1 month

  • Change of numeric rating scale (NRS)

    1 month

Study Arms (1)

VC plus herbal medicine

EXPERIMENTAL

Vitamin C 300 mg/day, TID, PO. Reishi, 2 g/day, BID, PO. Cordyceps, 2 g/day, BID, PO.

Drug: VC plus herbal medicine

Interventions

VC plus herbal medicineDRUG

Vitamin C 300 mg/day, TID, PO. Reishi, 2 g/day, BID, PO. Cordyceps, 2 g/day, BID, PO.

VC plus herbal medicine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to understand and the willingness to sign a written informed consent document.
  • Age ≥ 18 years and ≤ 80 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Histologically or cytologically confirmed metastatic pancreas adenocarcinoma.
  • Tumor progression after two lines of treatments.
  • Adequate organ performance based on laboratory blood tests.
  • Presence of at least of one measurable lesion in agreement to RECIST criteria.
  • The expected survival ≥ 1 months.
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

You may not qualify if:

  • The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
  • Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
  • Pregnant or nursing women.
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
  • Renal insufficiency or dialysis
  • Other serious accompanying illnesses, which, in the researcher\'s opinion, could seriously adversely affect the safety of the treatment.
  • Patients who are unwilling or unable to comply with study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Cancer Center

Shanghai, China

RECRUITING

Related Publications (3)

  • Das G, Shin HS, Leyva-Gomez G, Prado-Audelo MLD, Cortes H, Singh YD, Panda MK, Mishra AP, Nigam M, Saklani S, Chaturi PK, Martorell M, Cruz-Martins N, Sharma V, Garg N, Sharma R, Patra JK. Cordyceps spp.: A Review on Its Immune-Stimulatory and Other Biological Potentials. Front Pharmacol. 2021 Feb 8;11:602364. doi: 10.3389/fphar.2020.602364. eCollection 2020.

    PMID: 33628175BACKGROUND

  • Wang X, Zhu X, Liu Y, Liu H, Xiao Z, Luo G. Efficacy of vitamin C on chemotherapy-related anemia in pancreatic cancer: study protocol for a randomized controlled trial. Trials. 2024 Jul 29;25(1):512. doi: 10.1186/s13063-024-08345-w.

    PMID: 39075587BACKGROUND

  • Sohretoglu D, Huang S. Ganoderma lucidum Polysaccharides as An Anti-cancer Agent. Anticancer Agents Med Chem. 2018;18(5):667-674. doi: 10.2174/1871520617666171113121246.

    PMID: 29141563BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Phytotherapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Guopei Luo, MD

    Shanghai Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huanyu Xia, MD

CONTACT

86 21 64031446xianhuanyu@fudanpci.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 19, 2024

Study Start

November 22, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

November 26, 2024

Record last verified: 2024-09

Locations

CN(1)