A Randomized Phase II Trial of Limonene for Pulmonary Nodule Chemoprevention

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 45
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Chest Hospital
RECRUITING
Shanghai
Contact Information
Primary
Ziyi Sheng, Master
shxkcru@163.com
22200000
Time Frame
Start Date: 2023-02
Estimated Completion Date: 2025-12
Participants
Target number of participants: 160
Treatments
Active_comparator: Limonene capsules(marketed product in China)
Limonene capsules(marketed product in China) donate by pharmaceutical company.
Placebo_comparator: Limonene capsules(Placebo)
Same smell, color and shape as limonene capsules(marketed product in China), without limonene in capsules.
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai Chest Hospital
Leads: Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov