Limonene for Pulmonary Nodule Chemoprevention

Last updated: February 2, 2023
Sponsor: Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

2

Condition

Pulmonary Nodules

Treatment

N/A

Clinical Study ID

NCT05525260
DISH-pGGO
  • Ages 45-75
  • Female

Study 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.

Eligibility Criteria

Inclusion

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): longestdiameter > 6 mm and < 20 mm; pure ground glass nodule; according to the judgment ofthe clinician, follow-up can be performed, and surgical excision is not recommendedfor the time being; the nodules did not disappear or were not significantly reduced bymore than 2 mm after six months follow-up; subjects should have at least one positivenodule when had multiple nodules.
  • ECOG performance status 0-1.
  • Those who accept and are willing to sign the informed consent.

Exclusion

Exclusion Criteria:

  • Subjects with the history of autoimmune diseases and severe gastrointestinal diseases;
  • Subjects suffering from malignant tumor, severe heart disease, severe liver or kidneydisease 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 thethree 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 ofnormal 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 inthis research.

Study Design

Total Participants: 160
Study Start date:
February 01, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Shanghai Chest Hospital

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

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