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.
Early prevention, early detection and early treatment of lung cancer can help reduce the incidence and improve the survival rate.Chemoprevention is known to have an important role in high-risk people because it has the potential to prevent or reverse the progression of lung cancer.Lung nodules are good targets for testing the efficacy of chemopreventive agents.So far,none of the chemopreventive agents have been shown to be effective. Limonene is widely found in the essential oils of traditional Chinese medicine tangerine peel, green peel and other plants. Its taste is sour, sweet and pungent. It has an aromatic odor effect. Limonene Capsule, a Chinese patent medicine, has been on the market, which is suitable for the treatment of cholecystitis, cholangitis, cholelithiasis, and postoperative biliary syndrome.Preliminary studies of the research group suggest that it has a potential anti-cancer effect. This randomized, double-blind, controlled trial studied limonene compared with placebo in treating high-risk patients with pure ground glass pulmonary nodules,so as to expand indications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
160
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.
Limonene capsules(Placebo)
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGChanges in the sum of longest diameters of target nodules (multiple nodules) between the drug group and the placebo group.
Difference in the sum of longest diameters of target nodules
Time frame: at baseline, three months and six months after administration
Overall response rate of participants as measured by RECIST criteria between the two groups
Difference in the overall response rate of participants
Time frame: at baseline, three months and six months after administration
Changes in the sum of longest diameters of baseline target nodules (multiple nodules) between the drug group and the placebo group
Difference in the sum of longest diameters of target nodules
Time frame: at baseline and twelve months after administration
Change in diameters of baseline target nodules (single nodule) detected by CT between the two groups.
Difference in the longest diameters of baseline target nodules
Time frame: at baseline, three months and six months after administration
Change in density of baseline target nodules between the two groups.
Difference in density of baseline target nodules
Time frame: at baseline, three months and six months after administration
Change in the longest diameters size of baseline non-target nodules between the two groups
Difference in the longest diameters of baseline non-target nodules
Time frame: at baseline, three months and six months after administration
Change in numbers of baseline non-target nodules between the two groups
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Difference in numbers of baseline non-target nodules
Time frame: at baseline, three months and six months after administration
Change in density of baseline non-target nodules between the two groups
Difference in density of baseline non-target nodules
Time frame: at baseline, three months and six months after administration
Adverse events
Incidence of adverse events
Time frame: at baseline, three months and six months after administration
Value of serum miRNA
Value of serum miRNA
Time frame: at baseline, three months and six months after administration
Cytokine detection
Value of cytokine detection
Time frame: at baseline, three months and six months after administration
Plasma metabolomics
Analysis of plasma metabolomics
Time frame: at baseline, three months and six months after administration
Proportion of circulating blood immune cells
Analysis of the proportion of circulating blood immune cells
Time frame: at baseline, three months and six months after administration