NCT00783705

Brief Summary

This randomized phase II trial is studying inositol to see how well it works compared with a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of inositol may prevent lung cancer. It is not yet known whether inositol is more effective than a placebo in preventing lung cancer in smokers with bronchial dysplasia.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
2 countries

4 active sites

Status
completed

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

October 31, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2008

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 25, 2015

Completed
Last Updated

December 5, 2017

Status Verified

October 1, 2017

Enrollment Period

5.5 years

First QC Date

October 31, 2008

Results QC Date

April 29, 2015

Last Update Submit

October 30, 2017

Conditions

Non-small Cell Lung CancerSquamous Lung Dysplasia

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis.

    The definitions of responses are: Complete response: regression of all dysplastic lesion (DL) found at baseline to lesions that were no worse than hyperplasia and no new DL that were mild dysplasia or worse; Partial response: regression of some but not all of the DL with no new lesions that are mild dysplasia or worse; Progressive disease: progression of one or more sites by two or more grades or new DL that were mild dysplasia or worse; Stable disease: no complete response, partial response or progression.

    From baseline up to 6 months

  • Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis.

    The definitions of responses are: Complete response: the regression of a dysplastic lesion (DL) of any grade to one classified as being hyperplastic/normal; Progressive disease: appearance of lesions that were classified as mild dysplasia or worse; Stable disease: lesions that are not classified as complete response or progressive disease

    From baseline up to 6 months

Secondary Outcomes (18)

  • Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment

    From baseline up to 6 months

  • Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia

    From baseline up to 6 months

  • Change in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray

    From baseline up to 6 months

  • Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)

    From baseline up to 6 months

  • Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)

    From baseline up to 6 months

  • +13 more secondary outcomes

Study Arms (2)

Arm I (inositol)

EXPERIMENTAL

Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.

Drug: inositol

Arm II (placebo)

EXPERIMENTAL

Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.

Other: placebo

Interventions

placeboOTHER

Given orally

Also known as: PLCB
Arm II (placebo)
inositolDRUG

Given orally

Also known as: myo-inositol
Arm I (inositol)

Eligibility Criteria

Age45 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed bronchial dysplasia in ≥ 1 site AND meets one of the following criteria:
  • Current or former smoker with ≥ a 30 pack-year smoking history and no history of lung cancer
  • Stage 0 or I non-small cell lung cancer (NSCLC) curatively treated by surgery (local ablation or resection), adjuvant chemotherapy, or radiotherapy with a ≥ 30 pack-year smoking history
  • At least 6 months since prior surgery, adjuvant chemotherapy, or radiotherapy
  • No current evidence of lung cancer by CT scan
  • No non-calcified lung nodules ≥ 10 mm diameter on spiral CT scan unless cancer is ruled out by PET/CT scan or by biopsy
  • ECOG performance status 0-1
  • Hemoglobin normal
  • Leukocyte count ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 1.5 times ULN
  • ALT and AST ≤ 1.5 times ULN
  • BUN ≤ 1.5 times ULN
  • +33 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Albuquerque Veterans Administration Medical Center

Albuquerque, New Mexico, 87108-5128, United States

Location

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Inositol

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Results Point of Contact

Title
Paul J. Limburg, M.D., M.P.H.
Organization
Mayo Clinic Rochester
limburg.paul@mayo.edu
507-284-2511

Study Officials

  • Paul Limburg

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2008

First Posted

November 3, 2008

Study Start

November 1, 2008

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

December 5, 2017

Results First Posted

August 25, 2015

Record last verified: 2017-10

Locations

CA(1)US(3)