An Early Phase 1 interventional study of Broccoli Sprout/Broccoli Seed Extract Supplement and Laboratory Biomarker Analysis in Cigarette Smoking-Related Carcinoma and Tobacco-Related Carcinoma, sponsored by National Cancer Institute (NCI). Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-28.
Sponsored by National Cancer Institute (NCI) · Early Phase 1, Interventional, and Prevention
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.
PRIMARY OBJECTIVES:
I. To determine whether broccoli sprout/broccoli seed extract supplement (Avmacol) increases the urinary excretion of the mercapturic acid of the tobacco carcinogen, benzene, in healthy volunteers who are current heavy smokers.
SECONDARY OBJECTIVES:
I. To determine whether Avmacol increases the urinary excretion of the mercapturic acids of other tobacco carcinogens, including acrolein and crotonaldehyde.
II. To determine whether Avmacol increases the urinary excretion of the mercapturic acids of tobacco carcinogens, normalized by bio-measurement of tobacco exposure.
III. To determine whether Avmacol upregulates the NRF2 target gene transcripts in the buccal cells of current smokers.
IV. To evaluate for a dose-response relationship between Avmacol and the detoxification of tobacco carcinogens and the expression of NRF2 target gene transcripts.
V. To determine the relationship between systemic study agent exposure and biomarker modulation.
EXPLORATORY OBJECTIVES:
I. To determine whether the GSTM1 and GSTT1 genotypes are important genetic modulators of detoxification of tobacco carcinogens with Avmacol treatment.
II. To bank specimens for future research including evaluation of tobacco gene signatures in buccal and nasal epithelium and buccal cell nuclear morphometry.
OUTLINE: Participants are randomized into 1 of 2 arms.
ARM I: Participants receive lower dose broccoli sprout/broccoli seed extract supplement orally (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.
ARM II: 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.
After completion of study, participants are followed up at 10-14 days.
475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.
This study's enrollment of 49 is below the median of 96 across 406 interventional studies indexed under Cigarette Smoking.
Browse Cigarette Smoking studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Drug page: Broccoli Sprout/Broccoli Seed Extract Supplement
Given PO
Also known as: Avmacol
Correlative studies
Ancillary studies
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.
Time frame: 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.
Time frame: Baseline up to 14 days post intervention
Change in the Urinary Excretion of the Mercapturic Acids of Acrolein and Crotonaldehyde
Change following 4 tablets per day and 8 tablets per day of Avmacol wad determined separately. Data presented as ratio of the geometric mean of overnight urinary excretion of the mercapturic acid of acrolein/crotonaldehyde between post intervention and baseline.
Time frame: Baseline up to 14 days post intervention
Change in the NRF2 Target Gene Transcripts
Change in the expression of NQO1 in the buccal cells after 8 tablets per day of Avmacol. Data presented as ratio of the geometric mean of the gene expression of NQO1 between post intervention and baseline.
Time frame: Baseline up to 14 days post intervention
Dose-response Relationship Between Avmacol Dose and Detoxification of Tobacco Carcinogens
Dose-response relationship between the Avmacol dose and the detoxification of tobacco carcinogens. Data presented as ratio of percent change of the overnight urinary excretion of mercapturic acid of benzene/acrolein/crotonaldehyde between the 8 tables and 4 tables dose.
Time frame: Up to 14 days post intervention
Systemic Study Agent Exposure
Change in the total urinary levels of sulforaphane and its glutathione-derived metabolites (i.e., the sum of the molar concentrations of sulforaphane and its glutathione-derived metabolites in urine). Data presented as ratio of the geometric mean of the total urinary levels of sulforaphane and its metabolites between post intervention and baseline.
Time frame: Up to 14 days post intervention
GSTM1 and GSTT1 Genotypes
Change in the urinary excretion of the mercapturic acids of tobacco carcinogens by GSTM1 and GSTT1 genotype. Data presented as ratio of the geometric mean of urinary excretion of mercapturic acid of benzene between post intervention and baseline for each genotype.
Time frame: Up to 14 days post intervention
| Milestone | Avmacol Low Dose First, Then High Dose | Avmacol High Dose First, Then Low Dose |
|---|---|---|
| Started | 25 | 24 |
| Completed | 25 | 23 |
| Not completed | 0 | 1 |
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.
| data presented as ratio; no unit | Avmacol |
|---|---|
| Change in Urinary Excretion of the Mercapturic Acid of Benzene Following 4 Tablets Per Day of Avmacol | 1.16 (0.998 to 1.344) |
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.
| data presented as ratio; no unit | Avmacol |
|---|---|
| Change in Urinary Excretion of the Mercapturic Acid of Benzene Following 8 Tablets Per Day of Avmacol | 1.19 (1.005 to 1.409) |
Change following 4 tablets per day and 8 tablets per day of Avmacol wad determined separately. Data presented as ratio of the geometric mean of overnight urinary excretion of the mercapturic acid of acrolein/crotonaldehyde between post intervention and baseline.
| data presented as ratio; no unit | Avmacol 4 Tablets | Avmacol 8 Tablets |
|---|---|---|
| Urindary excretion of mercapturic acid of acrolein | 1.11 (0.98 to 1.26) | 1.28 (1.06 to 1.53) |
| Urinary excretion of mercapturic acid of crotonaldehyde | 1.05 (0.90 to 1.22) | 1.18 (1.02 to 1.37) |
Change in the expression of NQO1 in the buccal cells after 8 tablets per day of Avmacol. Data presented as ratio of the geometric mean of the gene expression of NQO1 between post intervention and baseline.
| data presented as ratio; no unit | Avmacol 8 Tablets |
|---|---|
| Change in the NRF2 Target Gene Transcripts | 1.00 (0.98 to 1.02) |
Dose-response relationship between the Avmacol dose and the detoxification of tobacco carcinogens. Data presented as ratio of percent change of the overnight urinary excretion of mercapturic acid of benzene/acrolein/crotonaldehyde between the 8 tables and 4 tables dose.
| data presented as ratio; no unit | Avmacol |
|---|---|
| Mercapturic acid of benzene | 1.01 (0.89 to 1.15) |
| Mercapturic acid of acrolein | 1.14 (0.95 to 1.36) |
| Mercapturic acid of crotonaldehyde | 1.12 (0.95 to 1.32) |
Change in the total urinary levels of sulforaphane and its glutathione-derived metabolites (i.e., the sum of the molar concentrations of sulforaphane and its glutathione-derived metabolites in urine). Data presented as ratio of the geometric mean of the total urinary levels of sulforaphane and its metabolites between post intervention and baseline.
| data presented as ratio; no unit | Avmacol 4 Tablets | Avmacol 8 Tablets |
|---|---|---|
| Systemic Study Agent Exposure | 467.9 (264.7 to 826.9) | 990.0 (592.2 to 1655.1) |
Change in the urinary excretion of the mercapturic acids of tobacco carcinogens by GSTM1 and GSTT1 genotype. Data presented as ratio of the geometric mean of urinary excretion of mercapturic acid of benzene between post intervention and baseline for each genotype.
| data presented as ratio; no unit | Avmacol 4 Tablets | Avmacol 8 Tablets |
|---|---|---|
| Mercapturic acid of benzene in GSTM1-null participants | 1.23 (0.99 to 1.52) | 1.34 (0.98 to 1.84) |
| Mercapturic acid of benzene in GSTM1-positive participants | 1.10 (0.90 to 1.35) | 1.06 (0.93 to 1.21) |
| Mercapturic acid of benzene in GSTT1-null participants | 0.75 (0.54 to 1.04) | 1.16 (0.89 to 1.51) |
| Mercapturic acid of benzene in GSTT1-positive participants | 1.26 (1.08 to 1.47) | 1.20 (0.98 to 1.45) |
Collected over Two weeks of agent intervention. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Dose | 0/49 (0%) | 1/49 (2%) | 26/49 (53.1%) |
| Low Dose | 0/48 (0%) | 0/48 (0%) | 14/48 (29.2%) |
| Event | High Dose | Low Dose |
|---|---|---|
| Myocardial infarctionCardiac disorders | 1/49 | 0/48 |
| Event | High Dose | Low Dose |
|---|---|---|
| DiarrheaGastrointestinal disorders | 10/49 | 3/48 |
| Abdominal painGastrointestinal disorders | 10/49 | 1/48 |
| Gastrointestinal disorders, otherGastrointestinal disorders | 9/49 | 7/48 |
| FlatulenceGastrointestinal disorders | 7/49 | 3/48 |
| DyspepsiaGastrointestinal disorders | 3/49 | 1/48 |
| Age, Continuous(years) | Avmacol |
|---|---|
| Mean | 56 ± 9 |
| Sex: Female, Male(Participants) | Avmacol |
|---|---|
| Female | 26 |
| Male | 23 |
| Ethnicity (NIH/OMB)(Participants) | Avmacol |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 44 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Avmacol |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 44 |
| More than one race | 3 |
| Unknown or Not Reported | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Jan 2020, 22 months.
Results were first posted in Apr 2021, 1 year 3 months after primary completion.
Of 19 phase 1 interventional studies under Cigarette Smoking, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 29. This study's 22 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Broccoli Sprout/Broccoli Seed Extract Supplement
National Cancer Institute (NCI) →