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Limonene for Pulmonary Nodule Chemoprevention | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Limonene for Pulmonary Nodule Chemoprevention

A Randomized Phase II Trial of Limonene for Pulmonary Nodule Chemoprevention

NCT05525260•Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

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.

Eligibility

Age

45 - 75 years

Sex

FEMALE

Healthy Volunteers

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;
+6 more criteria

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

February 1, 2023

Primary Completion Date

February 1, 2024

Completion Date

December 1, 2025

Last Updated

February 6, 2023

Enrollment

160

ESTIMATED participants

Conditions

Pulmonary Nodules

Interventions

Limonene capsule

DRUG

Limonene capsules(Placebo)

DRUG

Contacts

Ziyi Sheng, Master

CONTACT

22200000 shxkcru@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Limonene for Pulmonary Nodule Chemoprevention

Inclusion Criteria

Exclusion Criteria

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