A Randomized, Double-blind, Placebo-controlled, Prospective, Multi-center Trial Evaluating the Improvement of Nutritional Status and Sarcopenia With Silkworm Pupa Tablets in Patients With Malignancies

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT07554807
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Gastrointestinal Cancers
  • Nutritional Deficiency
  • Sarcopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Silkworm pupa tablets — DRUG
    For Experimental arm: Dietary advice + Wanshili Longbao Silkworm Pupa Tablets, 2 tablets each time, 3 times daily, taken half an hour before meals
  • Placebo — DRUG
    Control arm: Dietary advice + Placebo, 2 tablets each time, 3 times daily, taken half an hour before meals.

Study Details

This is a randomized, double-blind, placebo-controlled, parallel-group, prospective, multi-center clinical trial, to evaluate the efficacy of silkworm pupa tablets in improving nutritional status and sarcopenia in patients with malignancies who have completed comprehensive treatment. All participants will be randomly assigned (1:1) to either experimental group (n=240): dietary advice + Wanshili Longbao Silkworm Pupa Tablets (main ingredients: freeze-dried active mulberry cocoon pupa powder, maltitol, milk mineral salt, mannitol, maltodextrin), 2 tablets three times daily before meals for 3 months, or control group (n=240): dietary advice + placebo (identical appearance), 2 tablets three times daily before meals for 3 months. The primary endpoint is sarcopenia prevalence at 3 months (based on AWGS 2019 criteria: muscle strength, muscle mass, and physical function).

Key Dates

First listed
Apr 28, 2026
Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm
    Dietary advice + Wanshili Longbao Silkworm Pupa Tablets, 2 tablets each time, 3 times daily, taken half an hour before meals
  • Placebo Comparator: Control Arm
    Dietary advice + Placebo, 2 tablets each time, 3 times daily, taken half an hour before meals.

Primary Outcome Measure

Sarcopenia prevalence [ Time Frame: 3 months ]

Central Contacts

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