Using Celecoxib to Prevent Progression in Peutz-Jeghers Syndrome

Celecoxib for Prevention of Progression in Peutz-Jeghers Syndrome: A Double-blind, Randomized, Placebo-controlled Trial

This study is testing whether the drug Celecoxib can help people with Peutz-Jeghers Syndrome reduce the size and number of their intestinal polyps to lower the need for surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 8 Years and up
• Sex: All
• Sponsor: Air Force Military Medical University, China (Academic / other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT06722534 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of Celecoxib, a nonsteroidal anti-inflammatory drug, to prevent the progression of Peutz-Jeghers Syndrome (PJS) in patients aged 8 years and older. PJS is characterized by the development of multiple gastrointestinal polyps and an increased risk of malignancies, leading to frequent surgical interventions. The trial aims to assess whether Celecoxib can reduce the number and size of small bowel polyps, potentially decreasing the need for surgical treatments. Participants will be randomly assigned to receive either Celecoxib or a placebo to evaluate the drug's effectiveness in managing this rare condition.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with Peutz-Jeghers Syndrome who are 8 years or older.

Not a fit: Patients with a history of severe allergic reactions to NSAIDs or those requiring immediate surgical intervention for intestinal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of surgeries and complications associated with small bowel polyps in patients with Peutz-Jeghers Syndrome.

How similar studies have performed: While the use of Celecoxib in this context is novel, similar studies on NSAIDs for polyp management have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

\- Patients with PJS ≥ 8 years of age

Diagnostic criteria for PJS: meeting any of the following criteria or presence of an STK11 gene variant:

1. Two or more histologically confirmed PJS hamartomatous polyps;
2. Any number of PJS polyps detected in an individual with a family history of PJS in close relative(s);
3. Characteristic mucocutaneous pigmentation in an individual with a family history of PJS in close relative(s);
4. Any number of PJS polyps in an individual with characteristic mucocutaneous pigmentation.

Exclusion Criteria:

1. Allergy to NSAIDs;
2. Long-term use of any dose of NSAIDs, including aspirin or celecoxib, within 6 months prior to enrollment (willing to undergo a 3-month washout period to restore eligibility);
3. Imaging indicate small intestinal polyps ≥ 3 cm in diameter, intestinal intussusception, intestinal obstruction or intestinal tumor at the time of enrollment;
4. Surgical treatment for small intestinal polyps within 2 years prior to enrollment;
5. Anticipated small bowel resection due to severe polyps within 6 months of enrollment;
6. Receiving other medications for gastrointestinal polyps;
7. Peptic ulcer within 3 months prior to enrollment;
8. Unstable cardiorespiratory condition;
9. Serious renal, hepatic or haematological dysfunction (creatinine \>1.5 × ULN; ALT \>1.5 × ULN, AST \>1.5 × ULN, ALP \>1.5 × ULN, TBIL \>2 × ULN; haemoglobin \<10 g/dL, platelet count \<100,000/mL, white blood cells \<3000/mL) or other systemic diseases are unsuitable for participation in this study;
10. Pregnancy or breastfeeding;
11. Unwilling or unable to sign the informed consent form

Where this trial is running

Xi'an, Shaanxi

• Xijing Hospital of Digestive Diseases, Air Force Military Medical University — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Hui Luo Associate professor

Conditions Peutz-Jeghers Syndrome; Celecoxib; Small Bowel Polyp