Clinical trial · Interventional
Limonene for Pulmonary Nodule Chemoprevention
A Randomized Phase II Trial of Limonene for Pulmonary Nodule Chemoprevention
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pulmonary Nodules | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Limonene capsule | Drug | — | UNRESOLVED |
| Limonene capsules(Placebo) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Limonene capsules(marketed product in China)
- description
- Limonene capsules(marketed product in China) donate by pharmaceutical company.
- interventionNames
- Drug: Limonene capsule
- type
- PLACEBO_COMPARATOR
- label
- Limonene capsules(Placebo)
- description
- Same smell, color and shape as limonene capsules(marketed product in China), without limonene in capsules.
- interventionNames
- Drug: Limonene capsules(Placebo)
Primary outcomes (1)
- measure
- Changes in the sum of longest diameters of target nodules (multiple nodules) between the drug group and the placebo group.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available