Limonene for Pulmonary Nodule Chemoprevention

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The prevention and treatment of lung nodules involves many fields in preventive medicine and clinical medicine. A nodule is a growth or lump that may be malignant (cancer) or benign (not cancer). This study is aim to investigate the chemopreventive effect of limonene in inhibiting the occurrence/progression of ground glass pulmonary nodules. It is expected that limonene can be used as a safe and effective chemopreventive agent for preventing the development/progress of pulmonary nodules as well as expanding the indications of limonene.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborator: Shanghai Chest Hospital

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.