Pancreatic CancerNCT06736678
Oral Immunonutrition Therapy to Reduce Acute Toxicity After Neoadjuvant Chemoradiotherapy Pancreatic Cancer Patients
A study testing Oral Immunonutrition in people with Pancreatic Cancer and Neoadjuvant Chemoradiotherapy, run by Sun Yat-sen University at 2 sites in China.
Trial summary
A prospective, single-arm clinical trial is conducted to investigate the role of oral immunonutrion in reducing acute toxicity after neoadjuvant chemoradiotherapy among pancreatic cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Neoadjuvant Chemoradiotherapy, Immunonutrition
- What is being tested?
- Oral Immunonutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesChina
- Study dates
- 26 Aug 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Pathologically confirmed pancreatic ductal epithelial malignant tumors;
- 2. Resectable pancreatic cancer treated with neoadjuvant chemoradiotherapy, or nonresectable locally advanced pancreatic cancer treated with neoadjuvant or radical chemoradiotherapy;
- 3.Nutritional Risk Screening 2002 (NRS2002) ≥3 and Patient-Generated Subjective Global Assessment (PG-SGA) performance status B;
- 4. Age 18 years and older;
- 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- 6. Expected survival time more than 3 months;
- 7. History of antineoplastic therapy;
Who cannot join
- 1. Known allergy or intolerance to any component of investigational Oral Immunonutrition;
- 2. History of Oral Immunonutrition use within one month prior to enrollment;
- 3. Tumor compresses the major duodenal papilla, and /or appeared jaundice, acute pancreatitis;
- 4. Patients with contraindications for antineoplastic therapy, such as coronary heart disease, cerebral infarction, cerebral hemorrhage or other serious diseases;
- 5. Liver, kidney and blood coagulation function failure;
- 6. Patients with hemopathy;
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- 7. Patients with active infections;
- 8. Patients with other primary tumor;
- 9. Patients with other medical diseases that seriously affected nutritional status;
- 10.Subjects deemed by the investigator have other factors that may be ineligible for enrollment;
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
WeiWei xiao, +86 020 8734 0951, xiaoww@sysucc.org.cn
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Weiwei Xiao, Doctor, ＋86-020-87340951, xiaoww@sysucc.org.cn
Weiwei Xiao, Doctor
About this study
Official title: Efficacy of Oral Immunonutrition Therapy in Reducing Acute Toxicity After Neoadjuvant Chemoradiotherapy Among Pancreatic Cancer Patients: a Prospective, Single-arm Clinical Trial
A prospective, single-arm clinical trial is conducted to investigate the role of oral immunonutrion in reducing acute toxicity after neoadjuvant chemoradiotherapy among pancreatic cancer patients.
Read the detailed description
Pancreatic cancer has a poor prognosis for its high malignancy. Radical surgical resection is an effective means for prolonging survival. However, only a few patients can be directly treated with surgical resection. Neoadjuvant therapy can reduce the tumor size, improve the relationship between the tumor and adjacent blood vessels，to gain surgical opportunities and prolonging patients' survival.
Nutritional treatment of cancer has been valued by more and more researchers. As an important branch of nutrition therapy, immunonutrition plays an important role in regulating the immune. Studies have shown that immunonutrition can reduce antitumor treatment related toxicity among patients with head and neck cancer, esophageal cancer. At present, most studies on immunonutrition therapy focus on perioperative patients, and there is no study on patients with pancreatic cancer undergoing radiotherapy.
This prospective, single-arm clinical trial aimed to explore the efficacy and safety of oral immunonutrition therapy in reducing acute toxicity after neoadjuvant chemoradiotherapy among pancreatic cancer patients. A total of 98 pancreatic cancer patients will be enrolled. All of the patients will receive oral immunonutrition therapy for 6 weeks from one week before radiotherapy. The total follow time is 4 months.
- Being tested
- Oral Immunonutrition
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ImmunonutritionDietary supplement
Patients receive enteral immunonutrition, Oral Impact® Nestle for 6 weeks from one week before radiotherapy;
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Dietary Supplement: Oral Immunonutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of grade 3 or higher acute toxicity related to neoadjuvant chemoradiotherapy
Grading of acute toxicity would be assessed according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Measured: Baseline, week 17
Secondary outcomes (10)
Usual Body Weight Percentage(UBW%)
The baseline weight would be considered as usual body weight. UBW%= current weight/usual weight ×100%
Measured: Baseline, Week 3,5,7,9,13,17
Nutritional Assessment
Patient-Generated Subjective Global Assessment（PG-SGA）
Measured: Baseline, Week 3,5,7,9,13,17
Nutritional Risk
Nutritional Risk Screening 2002 (NRS 2002)
Measured: Baseline, Week 3,5,7,9,13,17
Quality of Life
The European Organisation for Research and Treatment of Cancer quality of life (EORTC QLQ-C30)
Measured: Baseline, Week 3,5,7,9,13,17
Inflammatory Indexes
The serum level of procalcitonin (PCT),C-reactive protein(CRP) , serum amyloid A(SAA).
Measured: Baseline; Week 7;
Immunological Indexes
The white blood cell (WBC) count and neutrophil (NE) count.
Measured: Baseline; Week 7;
Disease Control Rate (DCR)
Disease control rate (DCR) was defined as the percentage of CR+PR+SD among the patients who could be evaluated for efficacy.
Measured: Baseline; Week 13,17;
Resectable Status Rate
Incidence rate of conversion from unresectable to resectable status after radiotherapy.
Resectable status was defined according to the National Comprehensive Cancer Network (NCCN) Guidelines Version 1 2012. Tumors considered resectable were defined by the following objective criteria: (1) no distant metastases, (2)venous involvement of the portal vein demonstrating tumor abutment with impingement and narrowing of the lumen, encasement of the superior mesenteric vein (SMV)/portal vein allowing for safe resection and reconstruction, (3) no extension to the celiac axis, (4) tumor abutment of the SMA not to exceed >180° of the circumference of the vessel wall.
Measured: Baseline; Week 13,17;
Radiotherapy Interruption (RTI)
Radiotherapy interruption (RTI) often occurs because of severe acute treatment-related toxicity, disease progression, and patients' treatment compliance. RTI was defined as the difference between radiation treatment time and planned radiation time.
Measured: Week 3,5,7,9;
Overall Survival (OS)
Overall survival was calculated from the date of treatment to either the date of death or last follow-up.
Measured: Week 17; Year 2;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start26 Aug 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WeiWei Xiao, Sun Yat-sen University
- Investigators
- Weiwei Xiao, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736678
- Sponsor's protocol ID
- B2023-360-01
- Status last verified
- Jul 2024
- First submitted
- 12 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Immunonutrition Therapy in Reducing Acute Toxicity After Neoadjuvant Chemoradiotherapy Among Pancreatic Cancer Patients: a Prospective, Single-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT06736678
- Acronym / sponsor ID
- B2023-360-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 17 Dec 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.
A prospective, single-arm clinical trial is conducted to investigate the role of oral immunonutrion in reducing acute toxicity after neoadjuvant chemoradiotherapy among pancreatic cancer patients.
Detailed description
Pancreatic cancer has a poor prognosis for its high malignancy. Radical surgical resection is an effective means for prolonging survival. However, only a few patients can be directly treated with surgical resection. Neoadjuvant therapy can reduce the tumor size, improve the relationship between the tumor and adjacent blood vessels，to gain surgical opportunities and prolonging patients' survival.
Nutritional treatment of cancer has been valued by more and more researchers. As an important branch of nutrition therapy, immunonutrition plays an important role in regulating the immune. Studies have shown that immunonutrition can reduce antitumor treatment related toxicity among patients with head and neck cancer, esophageal cancer. At present, most studies on immunonutrition therapy focus on perioperative patients, and there is no study on patients with pancreatic cancer undergoing radiotherapy.
This prospective, single-arm clinical trial aimed to explore the efficacy and safety of oral immunonutrition therapy in reducing acute toxicity after neoadjuvant chemoradiotherapy among pancreatic cancer patients. A total of 98 pancreatic cancer patients will be enrolled. All of the patients will receive oral immunonutrition therapy for 6 weeks from one week before radiotherapy. The total follow time is 4 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Oral Immunonutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Pathologically confirmed pancreatic ductal epithelial malignant tumors;
- 2. Resectable pancreatic cancer treated with neoadjuvant chemoradiotherapy, or nonresectable locally advanced pancreatic cancer treated with neoadjuvant or radical chemoradiotherapy;
- 3.Nutritional Risk Screening 2002 (NRS2002) ≥3 and Patient-Generated Subjective Global Assessment (PG-SGA) performance status B;
- 4. Age 18 years and older;
- 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
Key exclusion criteria (10 listed)
- 1. Known allergy or intolerance to any component of investigational Oral Immunonutrition;
- 2. History of Oral Immunonutrition use within one month prior to enrollment;
- 3. Tumor compresses the major duodenal papilla, and /or appeared jaundice, acute pancreatitis;
- 4. Patients with contraindications for antineoplastic therapy, such as coronary heart disease, cerebral infarction, cerebral hemorrhage or other serious diseases;
- 5. Liver, kidney and blood coagulation function failure;
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 |
|---|---|---|
| Oral ImmunonutritionPatients receive enteral immunonutrition, Oral Impact® Nestle for 6 weeks from one week before radiotherapy; | Dietary supplement | Intervention group |
Primary outcome
Incidence rate of grade 3 or higher acute toxicity related to neoadjuvant chemoradiotherapy
Time frame: Baseline, week 17
Grading of acute toxicity would be assessed according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
10 secondary outcomes
Usual Body Weight Percentage(UBW%)
Time frame: Baseline, Week 3,5,7,9,13,17
Nutritional Assessment
Time frame: Baseline, Week 3,5,7,9,13,17
Nutritional Risk
Time frame: Baseline, Week 3,5,7,9,13,17
Quality of Life
Time frame: Baseline, Week 3,5,7,9,13,17
Inflammatory Indexes
Time frame: Baseline; Week 7;
Immunological Indexes
Time frame: Baseline; Week 7;
Disease Control Rate (DCR)
Time frame: Baseline; Week 13,17;
Resectable Status Rate
Time frame: Baseline; Week 13,17;
Radiotherapy Interruption (RTI)
Time frame: Week 3,5,7,9;
Overall Survival (OS)
Time frame: Week 17; Year 2;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
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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. This study is not recruiting at the moment.
Weiwei Xiao principal investigator
Sun Yat-sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Immunonutrition in people with Pancreatic Cancer and Neoadjuvant Chemoradiotherapy, run by Sun Yat-sen University at 2 sites 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiwei Xiao (+86 020 8734 0951, xiaoww@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of grade 3 or higher acute toxicity related to neoadjuvant chemoradiotherapy (time frame: Baseline, week 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2024.