Clinical Trial of Lung Cancer Chemoprevention With Sulforaphane in Former Smokers
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 55 - 75 |
| Updated: | 10/11/2018 |
| Start Date: | January 25, 2018 |
| End Date: | September 30, 2022 |
| Contact: | Jian-Min Yuan, M.D., Ph.D. |
| Email: | yuanj@upmc.edu |
| Phone: | 412-864-7889 |
Randomized Clinical Trial of Lung Cancer Chemoprevention With Sulforaphane in Former Smokers
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.
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.
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.
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