Limonene for Pulmonary Nodule Chemoprevention
NCT05525260 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2023-02-06
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.
Conditions
- Pulmonary Nodules
Interventions
- DRUG
-
Limonene capsule
Citrus foods rich in D-limonene were forbiden 2 days before taking the drug (washout period), which was maintained after taking the drug.Limonene capsules group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo control group and limonene capsule administration group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the treatment group and the placebo control group at a ratio of 1:1. The drug was administered for 12 weeks, 3 times a day, 5 capsules each time.
- DRUG
-
Limonene capsules(Placebo)
Limonene capsules(Placebo)
Sponsors & Collaborators
-
Shanghai Chest Hospital
collaborator OTHER -
Shanghai Jiao Tong University School of Medicine
lead OTHER
Principal Investigators
-
Biyun Qian, Doctor · Shanghai Jiao Tong University School of Medicine
-
Rong Li, Doctor · Shanghai Chest Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-28
- Primary Completion
- 2024-02-29
- Completion
- 2025-12-31
Countries
- China
Study Locations
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