Trial Title:
Effect of Silkworm Pupa Tablets in Gastrointestinal Malignancies at Nutritional Risk Following Radical Surgery
NCT ID:
NCT06551675
Condition:
Nutritional Deficiency
Gastrointestinal Cancer
Frailty Syndrome
Conditions: Official terms:
Neoplasms
Gastrointestinal Neoplasms
Malnutrition
Frailty
Conditions: Keywords:
silkworm pupa tablets
gastrointestinal malignancies
nutritional risk
frailty
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Silkworm pupa tablets
Description:
Participants will begin taking the silkworm pupa tablets immediately upon enrollment,
1200mg/tablet, two tablets a time, twice a day (BID), with a treatment duration of three
months.
Arm group label:
Silkworm pupa tablets group
Intervention type:
Dietary Supplement
Intervention name:
Control product
Description:
The sham comparator contains 0.5% of the active ingredient of the study product,
indistinguishable in appearance. Participants will begin taking the control immediately
upon enrollment, 1200mg/tablet, two tablets a time, twice a day (BID), with a treatment
duration of three months.
Arm group label:
Control group
Summary:
This is a randomized, double-blind, very low dose parallel-controlled, prospective,
multi-center trial evaluating the improvement of nutritional status and frailty with
silkworm pupa tablets after radical resection of gastrointestinal malignancies for 3
months intervention. The primary endpoints are body weight and frailty prevalence, The
secondary endpoints are body mass index (BMI), skeletal muscle index (SMI) at the third
lumbar vertebra (L3-SMI), sarcopenia prevalence and quality of life.
Detailed description:
Previous study has indicated that silkworms pupae extracts may increase muscle mass and
strength, here we conduct a randomized, double-blind, very low dose parallel-controlled,
prospective, multi-center trial.
1. Study population: malignant gastrointestinal tumors, including gastric cancer,
colorectal cancer, esophageal cancer, and pancreatic cancer, and has undergone
radical surgical resection. If necessary, perioperative systemic treatment has been
completed by the time of screening, and has a nutritional risk score of ≥3 (based on
the NRS 2002 nutritional risk screening tool).
2. Sample size: totally 120 cases, including 60 cases in the experimental group and 60
cases in the control group.
3. Research content: In this study, participants will begin taking the trial product or
control immediately upon enrollment, with a treatment duration of 3
months.Experimental Group: Wanshililongbao silkworm pupa tablets. Control Group:
contains 0.5% of the active ingredient of the trial product, indistinguishable in
appearance.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Voluntarily participate in the clinical study, fully understand the study and sign
the informed consent form (ICF); willing and able to follow and complete all trial
procedures.
- Gender unrestricted, age at the time of signing ICF: ≥18 years, ≤80 years.
- Diagnosed with a malignant gastrointestinal tumor, including gastric cancer,
colorectal cancer, esophageal cancer, and pancreatic cancer, and has undergone
radical surgical resection. If necessary, perioperative systemic treatment has been
completed by the time of screening.
- At the time of screening, a nutritional risk score of ≥3 (based on the NRS 2002
nutritional risk screening tool) .
- In good general condition, with an ECOG performance status score of ≤2.
- Agree to provide peripheral blood, stool, and urine samples for biomarker analysis
during the study period.
Exclusion Criteria:
- At the time of screening, presence of tumor recurrence or metastasis.
- At the time of screening, presence of another active malignancy requiring concurrent
treatment.
- Expected survival of ≤3 months.
- Unable to take oral nutrition, requiring enteral feeding tubes, or having
malabsorption syndrome or any condition affecting gastrointestinal absorption; e.g.,
chronic diarrhea (watery stools; defecation frequency ≥5 times a day).
- Patients who are planning a pregnancy, are pregnant, or are breastfeeding.
- Allergic to any known components of the trial materials.
- Presence of serious primary diseases of the heart, brain, lungs, liver, kidneys,
endocrine, hematological, neurological, or other systems, or other acute or chronic
diseases that could significantly affect treatment and prognosis.
- Presence of other severe physical or mental illnesses or laboratory abnormalities
that may increase the risk associated with participation in the study, or patients
deemed unsuitable for participation by the researchers.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yuqiang Shan
Facility:
Name:
he First Affiliated Hospital, College of Medicine, Zhejiang University
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaosun Liu
Facility:
Name:
The First Affiliated Hospital, College of Medicine, Zhejiang University
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Weijia Fang
Facility:
Name:
The Second Affiliated Hospital, College of Medicine, Zhejiang University
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jian Chen
Start date:
August 14, 2024
Completion date:
November 2025
Lead sponsor:
Agency:
Xiaosun Liu, MD
Agency class:
Other
Source:
First Affiliated Hospital of Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06551675
