NCT05525260

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

August 9, 2022

Last Update Submit

February 2, 2023

Conditions

Pulmonary Nodules

Outcome Measures

Primary Outcomes (1)

  • Changes 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

    at baseline, three months and six months after administration

Secondary Outcomes (12)

  • Overall response rate of participants as measured by RECIST criteria between the two groups

    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

    at baseline and twelve months after administration

  • Change in diameters of baseline target nodules (single nodule) detected by CT between the two groups.

    at baseline, three months and six months after administration

  • Change in density of baseline target nodules between the two groups.

    at baseline, three months and six months after administration

  • Change in the longest diameters size of baseline non-target nodules between the two groups

    at baseline, three months and six months after administration

  • +7 more secondary outcomes

Study Arms (2)

Limonene capsules(marketed product in China)

ACTIVE COMPARATOR

Limonene capsules(marketed product in China) donate by pharmaceutical company.

Drug: Limonene capsule

Limonene capsules(Placebo)

PLACEBO COMPARATOR

Same smell, color and shape as limonene capsules(marketed product in China), without limonene in capsules.

Drug: Limonene capsules(Placebo)

Interventions

Limonene capsuleDRUG

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.

Also known as: DAN LENING capsule
Limonene capsules(marketed product in China)
Limonene capsules(Placebo)DRUG

Limonene capsules(Placebo)

Also known as: Placebo
Limonene capsules(Placebo)

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • Leukocytes: 3.5-9.5 109/L;
  • Absolute neutrophil count: 1.8-6.3 109/L;
  • Platelets: 125-350 109/L;
  • Total bilirubin: 5.0-21.0 µmol /L;
  • AST (SGOT)/ALT (SGPT): 0.8-1.5;
  • Serum creatinine: 41-81 μmol/L;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Interventions

Limonene

Condition Hierarchy (Ancestors)

Lung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cyclohexane MonoterpenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCyclohexenesMonoterpenesTerpenes

Study Officials

  • Biyun Qian, Doctor

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Rong Li, Doctor

    Shanghai Chest Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziyi Sheng, Master

CONTACT

22200000shxkcru@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 9, 2022

First Posted

September 1, 2022

Study Start

February 1, 2023

Primary Completion

February 1, 2024

Study Completion

December 1, 2025

Last Updated

February 6, 2023

Record last verified: 2023-02

Locations

CN(1)