Clinical Trial of Lung Cancer Chemoprevention With Sulforaphane in Former Smokers

NCT ID: NCT03232138

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-25
• Study Completion Date: 2023-02-17

Brief Summary

This research study involves taking an experimental anti-cancer dietary supplement called Sulforaphane (SF) or a placebo (product without any supplement content) over a period of twelve months in order to determine if it is a useful dietary supplement for prevention of lung cancer in humans.

The main goals of this research study are:

1. To learn about the effects of giving Sulforaphane (SF) to former smokers who are still at high risk of developing cancer due to their smoking history and whether or not their condition improves, stays the same or becomes worse after Sulforaphane (SF) is given.

2. To learn whether Sulforaphane (SF) might reverse some of the lung cell changes associated with future development of lung cancer.

Conditions

Lung Cancer

Keywords

Sulforaphane; Chemoprevention; Former Smokers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Sulforaphane (Study Drug)

Sulforaphane four tablets 2 times per day with breakfast and dinner each dose contains approximately 120 micromole of Sulforaphane

Group Type: EXPERIMENTAL

Sulforaphane

Intervention Type: DIETARY_SUPPLEMENT

Sulforaphane (SF) is a naturally occurring substance (phytochemical) found in cruciferous vegetables.

Placebo

Placebo (containing no active drug) four tablets 2 times per day with breakfast and dinner

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inactive ingredients

Interventions

Sulforaphane

Sulforaphane (SF) is a naturally occurring substance (phytochemical) found in cruciferous vegetables.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Inactive ingredients

Intervention Type: DRUG

Other Intervention Names

Avmacol®

Eligibility Criteria

Inclusion Criteria

1. Man or woman 55-75 years of age.

2. Patients with normal endobronchial biopsy findings or pre-cancerous lesions at baseline will be eligible for the study. Pre-cancerous lesions include (a) reserve cell hyperplasia, (b) squamous metaplasia, (c) mild dysplasia, (d) moderate dysplasia, and (e) severe dysplasia.

3. A former smoker who has a history of smoking with ≥30 pack-years, quits smoking within the past 10 years, and has ≥1 year sustained abstinence from smoking.

4. Female subjects must be of non-child bearing potential or must have a negative serum pregnancy test at screening (within 72 hours of first dose of study medication) if of childbearing potential.

5. Male and female subjects of childbearing potential must be willing to use adequate barrier methods of contraception from the time starting with the screening visit through 30 days after the last dose of study therapy.

6. Abstinence is acceptable if this is the established and preferred contraception for the subject.

7. Generally healthy with liver enzyme and blood count values within the ranges shown below on the blood sample drawn at the baseline screening visit. Specifically:

White blood cells ≥ 3,000/mL Total bilirubin ≤ 1.5 x ULN (upper limits of normal) AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN BUN and serum creatinine ≤ 1.5 x ULN Serum pregnancy test Negative

8. The presence of airflow obstruction on spirometry (GOLD II or greater, Forced Expiratory Volume in the first second (FEV1) <80%) Chronic Obstructive Pulmonary Disease (COPD); and/or any emphysema on CT scan.

9. Participants must have a Southwest Oncology Group (SWOG) performance status of 0-2

10. Participants must be able and willing to undergo a bronchoscopy before and after treatment for 12 months.

11. Patients must be fully informed of the investigational nature of this study and must sign an informed consent in accordance within institutional and regulatory guidelines.

Exclusion Criteria

1. Carcinoma in situ or invasive cancer on baseline endobronchial biopsy.

2. A malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

3. Severe lung disease or inability to undergo two bronchoscopies.

4. Had pneumonia or acute bronchitis for at least 2 weeks prior to enrollment.

5. Cardiac dysrhythmia that is potentially life-threatening, such as ventricular tachycardia, multifocal premature ventricular contractions or supraventricular tachycardias with a rapid ventricular response. Well-controlled atrial fibrillation or rare (< 2 minutes) premature ventricular contractions are not exclusionary.

6. Evidence of clinically active coronary artery disease, including myocardial infarction within 6 weeks, chest pain, or congestive heart failure, or any serious medical condition which would preclude a patient from undergoing a bronchoscopy or would jeopardize the goals of the study.

7. Hypoxemia (less than 90% saturation with supplemental oxygen).

8. Prior chemotherapy or thoracic radiation within the past 5 years.

9. Woman who is pregnant or plan to be pregnant in next 12 months, or is breast feeding or plan to begin breast feeding in next 12 months.

10. Life expectancy of < 12 months.

11. Have a history of irritable bowel disease such as Crohn's disease and ulcerative colitis.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Jian-Min Yuan, MD

OTHER

Sponsor Role: lead

Responsible Party

Jian-Min Yuan, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jian-Min Yuan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Univesity of Pittsburgh

Locations

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01CA213123

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19040278

Identifier Type: -

Identifier Source: org_study_id