Broccoli Sprout/Broccoli Seed Extract Supplement in Decreasing Toxicity in Heavy Smokers

NCT03402230 | Completed Early Phase 1 Results DMC FDA Drug

• 6 other identifiers: NCI-2017-02406N01-CN-2012-000311711022046UAZ2017-09-02N01CN00031P30CA023074
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized early phase I trial studies how well broccoli sprout/broccoli seed extract supplement works in decreasing toxicity in heavy smokers. Broccoli sprout/broccoli seed extract supplement is a dietary supplement made from broccoli sprout and seed extract powder, and may break down some of the cancer causing substances in tobacco smoke and produce substances that may protect cells from tobacco smoke-induced damage in current smokers.

Conditions

Cigarette Smoking-Related Carcinoma; Tobacco-Related Carcinoma

Outcome Measures

Primary Outcomes (2)

• Change in Urinary Excretion of the Mercapturic Acid of Benzene Following 4 Tablets Per Day of Avmacol

  Change in the overnight urinary excretion the mercapturic acid of benzene following 4 tablets per day of Avmacol. Data presented as ratio of the geometric mean of overnight urinary excretion the mercapturic acid of benzene between post intervention and baseline.

  Baseline up to 14 days post intervention

• Change in Urinary Excretion of the Mercapturic Acid of Benzene Following 8 Tablets Per Day of Avmacol

  Change in the overnight urinary excretion the mercapturic acid of benzene following 8 tablets per day of Avmacol. Data presented as ratio of the geometric mean of overnight urinary excretion the mercapturic acid of benzene between post intervention and baseline.

  Baseline up to 14 days post intervention

Secondary Outcomes (4)

• Change in the Urinary Excretion of the Mercapturic Acids of Acrolein and Crotonaldehyde

  Baseline up to 14 days post intervention

• Change in the NRF2 Target Gene Transcripts

  Baseline up to 14 days post intervention

• Dose-response Relationship Between Avmacol Dose and Detoxification of Tobacco Carcinogens

  Up to 14 days post intervention

• Systemic Study Agent Exposure

  Up to 14 days post intervention

Other Outcomes (1)

• GSTM1 and GSTT1 Genotypes

  Up to 14 days post intervention

Study Arms (2)

Arm I (Avmacol lower dose, Avmacol higher dose)

EXPERIMENTAL

Participants receive lower dose broccoli sprout/broccoli seed extract supplement PO daily for 10-14 days. After 10-14 days, participants receive higher dose broccoli sprout/broccoli seed extract supplement PO daily for 10-14 days.

Drug: Broccoli Sprout/Broccoli Seed Extract Supplement; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Arm II (Avmacol higher dose, Avmacol lower dose)

EXPERIMENTAL

Participants receive higher dose broccoli sprout/broccoli seed extract supplement PO daily for 10-14 days. After 10-14 days, participants receive lower dose broccoli sprout/broccoli seed extract supplement PO daily for 10-14 days.

Drug: Broccoli Sprout/Broccoli Seed Extract Supplement; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Interventions

Broccoli Sprout/Broccoli Seed Extract Supplement DRUG

Given PO

Also known as: Avmacol

Arm I (Avmacol lower dose, Avmacol higher dose); Arm II (Avmacol higher dose, Avmacol lower dose)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (Avmacol lower dose, Avmacol higher dose); Arm II (Avmacol higher dose, Avmacol lower dose)

Questionnaire Administration OTHER

Ancillary studies

Arm I (Avmacol lower dose, Avmacol higher dose); Arm II (Avmacol higher dose, Avmacol lower dose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current tobacco smokers with \>= 20 pack years of self-reported smoking exposure and a current average use of \>= 10 cigarettes/day
• Karnofsky performance scale \>= 70%
• Leukocytes \>= 3,000/microliter
• Absolute neutrophil count \>= 1,500/microliter
• Platelets \>= 100,000/microliter
• Total bilirubin =\< 2 x institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x ULN
• Creatinine =\< ULN
• Fertile subjects must use adequate contraception (abstinence, barrier methods, or birth control pills) prior to study entry and for the duration of study participation; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• History of invasive cancer within the past 2 years, with the exception of excised and cured non-melanoma skin cancer or carcinoma in situ of the cervix
• Chronic, current or recent (within the past 2 weeks) use of systemic steroid doses equivalent to prednisone \> 5 mg daily for continued use \> 14 days; use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed
• Participants may not be receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Avmacol
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or lactating women

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

University of Arizona Cancer Center - Prevention Research Clinic

Tucson, Arizona, 85719, United States

Location

Results Point of Contact

• Title: Sherry Chow, PhD
• Organization: University of Arizona

schow@azcc.arizona.edu

5206263358

Study Officials

• Julie E Bauman

  The University of Arizona Medical Center-University Campus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 18, 2018
• Study Start: February 20, 2018
• Primary Completion: January 10, 2020
• Study Completion: July 24, 2022
• Last Updated: June 28, 2023
• Results First Posted: April 30, 2021

Record last verified: 2023-06

Locations

US (2)