Pancreatic CancerPhase 2/3NCT06598033
Vitamin C Plus Cordyceps to Quality of Life in Patients With Terminal Stage Pancreatic Cancer
A Phase 2/3 study testing VC plus herbal medicine in people with Pancreatic Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- VC plus herbal medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2024to 1 Oct 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Show all 9Show fewer
- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Cancer Center
Shanghai
Yi Li, MD, 86 21 64175590 ext. 1307, liuyi@fudanpci.org
About this study
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.
Read the detailed description
Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, the PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity. In 2013, the MPACT trial has confirmed the efficacy of gemcitabine combined with nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the side-effects related to chemotherapy including anemia, hand/foot numbness, fatigue, nausea, and malnutrition have impaired the quality of life for patients.
Vitamin C, also called ascorbate, is an essential nutrient for the human body. It modulates metabolism, immune reaction, collagen synthesis, and iron absorption. Some studies have shown that high-dose intravenous Vitamin C may be effective against various types of cancer. Meanwhile, medium or low dose of Vitamin C may increase iron absorption, improve anemia, alleviate pain and hand/foot numbness, and thus improve the quality of life for patients with terminal stage pancreatic cancer. In addition, numerous evidence has proved the efficacy of Reishi and Cordyceps in alleviating the side effects related to chemotherapy.
The purpose of this study is to evaluate the efficacy of vitamin C plus herbal medicine on improving the quality of life for metastatic pancreatic cancer patients who are resistant to two lines of systemic chemotherapy, including gemcitabine based, fluorouracil based, or other regimen. Fifty patients who have tumor progression after receiving two lines of chemotherapy will be recruited. These patients will receive Vitamin C plus herbal medicine. Quality of life, rate of hand/foot numbness, severity of pain, rate of anemia, and overall survival are measured.
- Conditions
- Pancreatic Cancer
- Being tested
- VC plus herbal medicine
- Keywords
- Pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VC plus herbal medicineDrug
Vitamin C 300 mg/day, TID, PO. Reishi, 2 g/day, BID, PO. Cordyceps, 2 g/day, BID, PO.
| Study group | Role | What they receive |
|---|---|---|
| VC plus herbal medicine | Experimental | Vitamin C 300 mg/day, TID, PO. Reishi, 2 g/day, BID, PO. Cordyceps, 2 g/day, BID, PO. Receives: Drug: VC plus herbal medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (4)
Rate of hand-foot skin reaction, HFSR
Rate of HFSR after every cycle of treatment
Measured: 1 month
Rate of anemia
Rate of anemia after every cycle of treatment
Measured: 1 month
Overall survival，OS
OS of subjects from recruiting to the time of death from any cause
Measured: 1 month
Change of numeric rating scale (NRS)
Change of numeric rating scale (NRS) and the administration of analgesic drugs after every cycle of treatment. NRS scale 0-10. Higher scores mean a worse outcome.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start22 Nov 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guopei Luo, Fudan University
- Investigators
- Guopei Luo, MD, Principal investigator, Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598033
- Sponsor's protocol ID
- PTCA199-13
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33628175Wang 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.
PubMed 39075587Sohretoglu D, Huang S. Ganoderma lucidum Polysaccharides as An Anti-cancer Agent. Anticancer Agents Med Chem. 2018;18(5):667-674. doi: 10.2174/1871520617666171113121246.
PubMed 29141563
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin C Plus Cordyceps to Quality of Life in Patients With Terminal Stage Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06598033
- Acronym / sponsor ID
- PTCA199-13
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, the PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity. In 2013, the MPACT trial has confirmed the efficacy of gemcitabine combined with nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the side-effects related to chemotherapy including anemia, hand/foot numbness, fatigue, nausea, and malnutrition have impaired the quality of life for patients.
Vitamin C, also called ascorbate, is an essential nutrient for the human body. It modulates metabolism, immune reaction, collagen synthesis, and iron absorption. Some studies have shown that high-dose intravenous Vitamin C may be effective against various types of cancer. Meanwhile, medium or low dose of Vitamin C may increase iron absorption, improve anemia, alleviate pain and hand/foot numbness, and thus improve the quality of life for patients with terminal stage pancreatic cancer. In addition, numerous evidence has proved the efficacy of Reishi and Cordyceps in alleviating the side effects related to chemotherapy.
The purpose of this study is to evaluate the efficacy of vitamin C plus herbal medicine on improving the quality of life for metastatic pancreatic cancer patients who are resistant to two lines of systemic chemotherapy, including gemcitabine based, fluorouracil based, or other regimen. Fifty patients who have tumor progression after receiving two lines of chemotherapy will be recruited. These patients will receive Vitamin C plus herbal medicine. Quality of life, rate of hand/foot numbness, severity of pain, rate of anemia, and overall survival are measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VC plus herbal medicine | Experimental | Drug: VC plus herbal medicineVitamin C 300 mg/day, TID, PO. Reishi, 2 g/day, BID, PO. Cordyceps, 2 g/day, BID, PO. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (8 listed)
- • The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VC plus herbal medicineVitamin C 300 mg/day, TID, PO. Reishi, 2 g/day, BID, PO. Cordyceps, 2 g/day, BID, PO. | Drug | VC plus herbal medicine |
Primary outcome
Quality of life (QOL) questionnaire
Time frame: 1 month
Change of QOL after every cycle of treatment using ORTC QLQ-C30 (version 3). Scale 1-7, higher scores mean a better outcome.
4 secondary outcomes
Rate of hand-foot skin reaction, HFSR
Time frame: 1 month
Rate of anemia
Time frame: 1 month
Overall survival，OS
Time frame: 1 month
Change of numeric rating scale (NRS)
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Background: PubMed 33628175Das 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.
- Background: PubMed 39075587Wang 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.
- Background: PubMed 29141563Sohretoglu D, Huang S. Ganoderma lucidum Polysaccharides as An Anti-cancer Agent. Anticancer Agents Med Chem. 2018;18(5):667-674. doi: 10.2174/1871520617666171113121246.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guopei Luo, MD principal investigator
Shanghai Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing VC plus herbal medicine in people with Pancreatic Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huanyu Xia, MD (86 21 64031446, xianhuanyu@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (QOL) questionnaire (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06598033, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.