Using limonene to prevent lung nodules from becoming cancerous

A Randomized Phase II Trial of Limonene for Pulmonary Nodule Chemoprevention

This study is testing if limonene capsules can help prevent lung nodules from turning into cancer in people who are at high risk.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 45 Years to 75 Years
• Sex: Female
• Sponsor: Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05525260 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the chemopreventive effects of limonene on pure ground glass pulmonary nodules in high-risk patients. It is a randomized, double-blind, controlled trial comparing limonene capsules to a placebo. The study aims to determine if limonene can inhibit the occurrence and progression of these nodules, which may lead to lung cancer. Participants will be monitored through high-resolution CT scans to assess the effectiveness of the treatment over time.

Who should consider this trial

Good fit: Ideal candidates for this study are non-smokers with specific types of pulmonary nodules that meet the inclusion criteria.

Not a fit: Patients with a history of autoimmune diseases, severe gastrointestinal diseases, or current malignant tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safe and effective method for preventing the progression of pulmonary nodules into lung cancer.

How similar studies have performed: While chemoprevention is a recognized field, no previous chemopreventive agents have shown effectiveness for pulmonary nodules, making this approach novel.

Eligibility criteria

Inclusion Criteria:

* Non-smokers (those who have smoked less than 100 cigarettes in their lifetime, including those who have never smoked in their lifetime).
* Subjects must have positive nodules detected by high-resolution CT（HRCT）: longest diameter \> 6 mm and \< 20 mm; pure ground glass nodule; according to the judgment of the clinician, follow-up can be performed, and surgical excision is not recommended for the time being; the nodules did not disappear or were not significantly reduced by more than 2 mm after six months follow-up; subjects should have at least one positive nodule when had multiple nodules.
* ECOG performance status 0-1.
* Those who accept and are willing to sign the informed consent.

Exclusion Criteria:

* Subjects with the history of autoimmune diseases and severe gastrointestinal diseases;
* Subjects suffering from malignant tumor, severe heart disease, severe liver or kidney disease currently or within the past 5 years;
* Within 6 weeks since prior herbal supplements, non-steroidal anti-inflammatory drugs, or antibiotics
* Subjects who are allergic to limonene capsules or citrus foods;
* Use of any other investigational agents at time of enrollment in the study during the three months preceding study enrollment
* Pregnant or lactating females, or those who disagreeing with contraception;
* Subjects who have a history of mental illness and cannot cooperate with this project;
* HIV-positive subjects should be excluded.
* Subjects whose organ and bone marrow function indexes exceeded the following range of normal value were excluded:

  1. Leukocytes: 3.5-9.5 109/L;
  2. Absolute neutrophil count: 1.8-6.3 109/L;
  3. Platelets: 125-350 109/L;
  4. Total bilirubin: 5.0-21.0 µmol /L;
  5. AST (SGOT)/ALT (SGPT): 0.8-1.5;
  6. Serum creatinine: 41-81 μmol/L;
* Other situations where the researcher thinks it is inappropriate to participate in this research.

Where this trial is running

Shanghai, Shanghai

• Shanghai Chest Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Biyun Qian, Doctor — Shanghai Jiao Tong University School of Medicine
• Study coordinator: Ziyi Sheng, Master

Conditions Pulmonary Nodules