Hematopoietic and Lymphatic System NeoplasmPhase 2NCT06009926
Evaluation of Broccoli Seed and Sprout Extract for Detoxification of Carcinogens in Firefighters
A Phase 2 study testing Acetaminophen, Biospecimen Collection and Broccoli Sprout/Broccoli Seed Extract Supplement in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II randomized, placebo-controlled trial evaluates whether daily supplementation with broccoli seed and sprout extract (BSSE), also known as Avmacol Extra Strength (ES), enhances the body's natural ability to detoxify carcinogens commonly encountered by firefighters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm, Occupational Malignant Neoplasm
- What is being tested?
- Acetaminophen, Biospecimen Collection and Broccoli Sprout/Broccoli Seed Extract Supplement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to 1 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female incumbent firefighters who are current non-smokers.
- Age >= 18 years.
- Karnofsky performance scale >= 70%.
- Absolute neutrophil count >= 1,000/microliter.
- Platelets >= 100,000/microliter.
- Total bilirubin =< 2 x institutional upper limit of normal (ULN).
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- Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase [SGPT]) =< 2 x ULN.
- Creatinine =< 1.5 x ULN.
- Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible.
- The effects of BSSE on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, 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.
Who cannot join
- History of invasive cancer within the past 2 years, except for excised and cured non-melanoma skin cancer or carcinoma in situ of the cervix. Participants who continue adjuvant treatment for an index cancer occurring > 2 years ago, such as adjuvant hormonal therapy for breast cancer, are excluded. Participants who are on anti-neoplastic treatment for a chronic malignancy, such as multiple myeloma or chronic myelogenous leukemia, are excluded.
- 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 (< 10% body surface area) 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 ES (BSSE).
- Uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or lactating women. Pregnant women are excluded from this study because the effects of BSSE on the developing human fetus are unknown. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with BSSE, breastfeeding should be discontinued if the mother is treated with BSSE.
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- Participants with known human immunodeficiency virus (HIV), chronic hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Participants with HIV, HBV and HCV are excluded from this study because there is no information regarding the impact of anti-viral drugs on the bioavailability of Avmacol ES. Sulforaphane (SF) is known to modulate certain phase 1 and phase 2 enzymes involved in drug metabolism. The potential for SF to alter the metabolism (either by increasing or decreasing) of antiviral therapy could have an effect on the efficacy of the pharmaceuticals to keep viral titers low and the disease under control. Since many of the drugs used in therapies of these viral infections have extensive CYP450 enzymatic impact and BSSE has its own enzymatic properties, there is concern for drug-to-drug interactions.
- Ongoing use of any supplements containing active compounds in cruciferous vegetables such as SF and glucoraphanin (GR). The use of supplements related to the study agent may confound the study endpoints. Participant will be eligible if they agree to stop the SF or GR product at least 14 days prior to the baseline visit.
- History of allergic reactions to acetaminophen or the formulation ingredients or any other contraindication to acetaminophen use.
- Unwilling or unable to refrain from the use of non-study acetaminophen (or acetaminophen containing products) for 72 hours prior to the baseline evaluation of acetaminophen metabolism and for 72 hours prior to the end-of-intervention evaluation of acetaminophen metabolism.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Cancer Center - Prevention Research Clinic
Tucson, Arizona, 85719
About this study
Official title: Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Broccoli Seed and Sprout Extract (BSSE) to Evaluate Detoxification of Carcinogens in Firefighters
This phase II randomized, placebo-controlled trial evaluates whether daily supplementation with broccoli seed and sprout extract (BSSE), also known as Avmacol Extra Strength (ES), enhances the body's natural ability to detoxify carcinogens commonly encountered by firefighters. Firefighters are routinely exposed to harmful chemicals such as benzene and polycyclic aromatic hydrocarbons (PAHs) through smoke inhalation, structural fires, and fuel leak incidents exposures that contribute to their elevated cancer risk. BSSE contains bioactive compounds known to activate phase II detoxification enzymes that help eliminate reactive toxins from the body. A single dose of acetaminophen (Tylenol) is administered at both baseline and end-of-intervention as a metabolic probe to assess changes in detoxification enzyme activity. Acetaminophen is metabolized through the same pathways as benzene and PAHs, making it a useful surrogate for evaluating the effect of BSSE on the detoxification of fire-related toxicants. Participants were originally randomized into one of total four study groups. Groups I and II, now closed to accrual, were designed to assess BSSE effects before and after controlled flashover fire training exercises. These arms were discontinued after it was determined that training fires produced insufficient real-world toxicant exposure to evaluate the intervention's impact. Groups III and IV were subsequently open and represent the active phase of the study. Group III participants receive BSSE daily for 12 weeks, while Group IV participants receive a matched placebo. Both groups include acetaminophen challenge at baseline and end-of-intervention, with biospecimen collection to evaluate detoxification capacity and explore genetic and epigenetic modifiers of response. Although the protocol includes four study groups, only two are currently active. Groups I and II remain part of the study record but are closed and will not contribute to the primary outcome analyses.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine whether BSSE increases the urinary excretion of mercapturic acid of acetaminophen, a surrogate for detoxification of the carcinogen benzene in healthy, incumbent firefighters.
SECONDARY OBJECTIVES:
- To evaluate the effects of BSSE on urinary excretion of acetaminophen glucuronide, a surrogate for detoxification of polycyclic aromatic hydrocarbons (PAHs).
II. To evaluate the safety and tolerability of BSSE.
EXPLORATORY OBJECTIVES:
- To determine whether the GSTM1 and GSTT1 genotypes are important genetic modulators of BSSE-induced detoxification of carcinogens.
II. To evaluate the effects of BSSE on urinary metabolomics. III. To determine the effects of BSSE on the urinary excretion of the mercapturic acid of benzene after fire/fuel leak activities.
IV. To determine the effects of BSSE on the urinary excretion of metabolites of PAHs after fire/fuel leak activities.
- To determine the effects of BSSE on epigenetic modifications (blood microribonucleic acid [RNA] and deoxyribonucleic acid [DNA] methylation).
OUTLINE: Participants are randomized to Group III or Group IV.
GROUP I (BSSE-PLACEBO) (CLOSED TO ACCRUAL 10/07/2024): Participants receive BSSE orally (PO) daily (QD) for 7-10 days then undergo the first flashover training between day 7-10 of agent intervention. Participants then receive placebo PO QD for 7-10 days then undergo second flashover training after a washout period of 2 weeks to 3 months. Participants also undergo urine sample collection throughout the study.
GROUP II (PLACEBO-BSSE) (CLOSED TO ACCRUAL 10/07/2024): Participants receive placebo PO QD for 7-10 days then undergo the first flashover training between day 7-10 of agent intervention. Participants then receive BSSE for 7-10 days then undergo second flashover training after a washout period of 2 weeks to 3 months. Participants also undergo urine sample collection throughout the study.
GROUP III: Participants receive BSSE PO QD for 12 weeks on study. Participants also receive acetaminophen PO once prior to starting BSSE and once following completion of BSSE on study. Participants undergo blood and urine sample collection throughout the study.
GROUP IV: Participants receive placebo PO QD for 12 weeks on study. Participants also receive acetaminophen PO once prior to starting placebo and once following completion of placebo on study. Participants undergo blood and urine sample collection throughout the study.
After completion of study intervention, participants are followed up at 2 weeks.
- Conditions
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm, Occupational Malignant Neoplasm
- Being tested
- Acetaminophen, Biospecimen Collection, Broccoli Sprout/Broccoli Seed Extract Supplement, Placebo Administration, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called APAP, Paracetamol, Tylenol
Given PO
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood and urine sample collection
Broccoli Sprout/Broccoli Seed Extract SupplementDietary supplement
Also called Avmacol
Given PO
Placebo AdministrationDrug
Given PO
Questionnaire AdministrationOther
Ancillary studies
TrainingOther
Also called Training Programs
Undergo flashover training
| Study group | Role | What they receive |
|---|---|---|
| Group I (BSSE-placebo) | Experimental | Participants receive BSSE PO QD for 7-10 days then undergo the first flashover training between day 7-10 of agent intervention. Participants then receive placebo PO QD for 7-10 days then undergo second flashover training after a washout period of 2 weeks to 3 months. Participants also undergo urine sample collection throughout the study. (CLOSED TO ACCRUAL 10/07/2024) Receives: Procedure: Biospecimen Collection; Dietary Supplement: Broccoli Sprout/Broccoli Seed Extract Supplement; Drug: Placebo Administration; Other: Questionnaire Administration; Other: Training |
| Group II (placebo-BSSE) | Experimental | Participants receive placebo PO QD for 7-10 days then undergo the first flashover training between day 7-10 of agent intervention. Participants then receive BSSE for 7-10 days then undergo second flashover training after a washout period of 2 weeks to 3 months. Participants also undergo urine sample collection throughout the study. (CLOSED TO ACCRUAL 10/07/2024) Receives: Procedure: Biospecimen Collection; Dietary Supplement: Broccoli Sprout/Broccoli Seed Extract Supplement; Drug: Placebo Administration; Other: Questionnaire Administration; Other: Training |
| Group III (BSSE, acetaminophen) | Experimental | Participants receive BSSE PO QD for 12 weeks on study. Participants also receive acetaminophen PO once prior to starting BSSE and once following completion of BSSE on study. Participants undergo blood and urine sample collection throughout the study. Receives: Drug: Acetaminophen; Procedure: Biospecimen Collection; Dietary Supplement: Broccoli Sprout/Broccoli Seed Extract Supplement; Other: Questionnaire Administration |
| Group IV (placebo, acetaminophen) | Active comparator | Participants receive placebo PO QD for 12 weeks on study. Participants also receive acetaminophen PO once prior to starting placebo and once following completion of placebo on study. Participants undergo blood and urine sample collection throughout the study. Receives: Drug: Acetaminophen; Procedure: Biospecimen Collection; Drug: Placebo Administration; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total amount of acetaminophen mercapturate excreted in the urine
Will compare after acetaminophen dosing between broccoli seed and sprout extract (BSSE) and placebo arms. Will be quantified by liquid chromatography tandem mass spectrometry. Log-transformation will be applied to total amount of acetaminophen mercapturate before deriving the changes at the end of intervention from baseline since the total amount of acetaminophen mercapturate may be highly right skewed. Even if the total amount of acetaminophen mercapturate is not highly right skewed, log-transformation will also allow comparison of the relative percent change in total amount of acetaminophen mercapturate at the end of intervention from baseline between the BSSE and placebo groups through use of the geometric mean of total amount of acetaminophen mercapturate. Will be analyzed in participants who initiated treatment and provided both pre-study agent intervention and post-study agent intervention urine.
Measured: Baseline to end-of-intervention
Secondary outcomes (3)
Change in total amount of acetaminophen glucuronide excreted in the urine
Will compare after acetaminophen dosing between BSSE and placebo arms. Will be quantified by liquid chromatography tandem mass spectrometry.
Measured: Baseline to end-of-intervention
Incidence of adverse events
Will evaluate safety of BSSE, as measured by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5. Toxicity will be measured by adverse events (AE) classified in accordance with NCI CTCAE version 5. The frequency and associated percentage of each specific AE will be tabulated by treatment group and then compared via Fisher's exact test. All participants will be evaluable for toxicity from the time of their first dose of BSSE versus placebo. Descriptive statistics of the type and frequency of all AEs will be generated, including 95% confidence intervals.
Measured: Start of intervention to follow-up
Adherence rate
Tolerability will be measured by adherence rate and will be compared between the BSSE and placebo via Fisher's exact test.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start4 Dec 2023
- Primary completion28 Feb 2026
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Malvi Savani, Principal investigator, University of Arizona Cancer Center - Prevention Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009926
- Sponsor's protocol ID
- NCI-2023-06404
- Other IDs
- NCI-2023-06404, STUDY00003544, UAZ22-11-01, P30CA023074, UG1CA242596
- Status last verified
- Sep 2026
- First submitted
- 23 Aug 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Broccoli Seed and Sprout Extract (BSSE) to Evaluate Detoxification of Carcinogens in Firefighters
- ClinicalTrials.gov ID
- NCT06009926
- Acronym / sponsor ID
- NCI-2023-06404
- Conditions
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm, Occupational Malignant Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II randomized, placebo-controlled trial evaluates whether daily supplementation with broccoli seed and sprout extract (BSSE), also known as Avmacol Extra Strength (ES), enhances the body's natural ability to detoxify carcinogens commonly encountered by firefighters. Firefighters are routinely exposed to harmful chemicals such as benzene and polycyclic aromatic hydrocarbons (PAHs) through smoke inhalation, structural fires, and fuel leak incidents exposures that contribute to their elevated cancer risk. BSSE contains bioactive compounds known to activate phase II detoxification enzymes that help eliminate reactive toxins from the body. A single dose of acetaminophen (Tylenol) is administered at both baseline and end-of-intervention as a metabolic probe to assess changes in detoxification enzyme activity. Acetaminophen is metabolized through the same pathways as benzene and PAHs, making it a useful surrogate for evaluating the effect of BSSE on the detoxification of fire-related toxicants. Participants were originally randomized into one of total four study groups. Groups I and II, now closed to accrual, were designed to assess BSSE effects before and after controlled flashover fire training exercises. These arms were discontinued after it was determined that training fires produced insufficient real-world toxicant exposure to evaluate the intervention's impact. Groups III and IV were subsequently open and represent the active phase of the study. Group III participants receive BSSE daily for 12 weeks, while Group IV participants receive a matched placebo. Both groups include acetaminophen challenge at baseline and end-of-intervention, with biospecimen collection to evaluate detoxification capacity and explore genetic and epigenetic modifiers of response. Although the protocol includes four study groups, only two are currently active. Groups I and II remain part of the study record but are closed and will not contribute to the primary outcome analyses.
Detailed description
PRIMARY OBJECTIVE:
- To determine whether BSSE increases the urinary excretion of mercapturic acid of acetaminophen, a surrogate for detoxification of the carcinogen benzene in healthy, incumbent firefighters.
SECONDARY OBJECTIVES:
- To evaluate the effects of BSSE on urinary excretion of acetaminophen glucuronide, a surrogate for detoxification of polycyclic aromatic hydrocarbons (PAHs).
II. To evaluate the safety and tolerability of BSSE.
EXPLORATORY OBJECTIVES:
- To determine whether the GSTM1 and GSTT1 genotypes are important genetic modulators of BSSE-induced detoxification of carcinogens.
II. To evaluate the effects of BSSE on urinary metabolomics. III. To determine the effects of BSSE on the urinary excretion of the mercapturic acid of benzene after fire/fuel leak activities.
IV. To determine the effects of BSSE on the urinary excretion of metabolites of PAHs after fire/fuel leak activities.
- To determine the effects of BSSE on epigenetic modifications (blood microribonucleic acid [RNA] and deoxyribonucleic acid [DNA] methylation).
OUTLINE: Participants are randomized to Group III or Group IV.
GROUP I (BSSE-PLACEBO) (CLOSED TO ACCRUAL 10/07/2024): Participants receive BSSE orally (PO) daily (QD) for 7-10 days then undergo the first flashover training between day 7-10 of agent intervention. Participants then receive placebo PO QD for 7-10 days then undergo second flashover training after a washout period of 2 weeks to 3 months. Participants also undergo urine sample collection throughout the study.
GROUP II (PLACEBO-BSSE) (CLOSED TO ACCRUAL 10/07/2024): Participants receive placebo PO QD for 7-10 days then undergo the first flashover training between day 7-10 of agent intervention. Participants then receive BSSE for 7-10 days then undergo second flashover training after a washout period of 2 weeks to 3 months. Participants also undergo urine sample collection throughout the study.
GROUP III: Participants receive BSSE PO QD for 12 weeks on study. Participants also receive acetaminophen PO once prior to starting BSSE and once following completion of BSSE on study. Participants undergo blood and urine sample collection throughout the study.
GROUP IV: Participants receive placebo PO QD for 12 weeks on study. Participants also receive acetaminophen PO once prior to starting placebo and once following completion of placebo on study. Participants undergo blood and urine sample collection throughout the study.
After completion of study intervention, participants are followed up at 2 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I (BSSE-placebo) | Experimental | Procedure: Biospecimen Collection, Dietary Supplement: Broccoli Sprout/Broccoli Seed Extract Supplement, Drug: Placebo Administration, Other: Questionnaire Administration, Other: TrainingParticipants receive BSSE PO QD for 7-10 days then undergo the first flashover training between day 7-10 of agent intervention. Participants then receive placebo PO QD for 7-10 days then undergo second flashover training after a washout period of 2 weeks to 3 months. Participants also undergo urine sample collection throughout the study. (CLOSED TO ACCRUAL 10/07/2024) |
| Group II (placebo-BSSE) | Experimental | Procedure: Biospecimen Collection, Dietary Supplement: Broccoli Sprout/Broccoli Seed Extract Supplement, Drug: Placebo Administration, Other: Questionnaire Administration, Other: TrainingParticipants receive placebo PO QD for 7-10 days then undergo the first flashover training between day 7-10 of agent intervention. Participants then receive BSSE for 7-10 days then undergo second flashover training after a washout period of 2 weeks to 3 months. Participants also undergo urine sample collection throughout the study. (CLOSED TO ACCRUAL 10/07/2024) |
| Group III (BSSE, acetaminophen) | Experimental | Drug: Acetaminophen, Procedure: Biospecimen Collection, Dietary Supplement: Broccoli Sprout/Broccoli Seed Extract Supplement, Other: Questionnaire AdministrationParticipants receive BSSE PO QD for 12 weeks on study. Participants also receive acetaminophen PO once prior to starting BSSE and once following completion of BSSE on study. Participants undergo blood and urine sample collection throughout the study. |
| Group IV (placebo, acetaminophen) | Active comparator | Drug: Acetaminophen, Procedure: Biospecimen Collection, Drug: Placebo Administration, Other: Questionnaire AdministrationParticipants receive placebo PO QD for 12 weeks on study. Participants also receive acetaminophen PO once prior to starting placebo and once following completion of placebo on study. Participants undergo blood and urine sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female incumbent firefighters who are current non-smokers.
- Age >= 18 years.
- Karnofsky performance scale >= 70%.
- Absolute neutrophil count >= 1,000/microliter.
- Platelets >= 100,000/microliter.
Key exclusion criteria (10 listed)
- History of invasive cancer within the past 2 years, except for excised and cured non-melanoma skin cancer or carcinoma in situ of the cervix. Participants who continue adjuvant treatment for an index cancer occurring > 2 years ago, such as adjuvant hormonal therapy for breast cancer, are excluded. Participants who are on anti-neoplastic treatment for a chronic malignancy, such as multiple myeloma or chronic myelogenous leukemia, are excluded.
- 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 (< 10% body surface area) 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 ES (BSSE).
- Uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenAlso: APAP, Paracetamol, TylenolGiven PO | Drug | Group III (BSSE, acetaminophen), Group IV (placebo, acetaminophen) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood and urine sample collection | Procedure or surgery | Group I (BSSE-placebo), Group II (placebo-BSSE), Group III (BSSE, acetaminophen), Group IV (placebo, acetaminophen) |
| Broccoli Sprout/Broccoli Seed Extract SupplementAlso: AvmacolGiven PO | Dietary supplement | Group I (BSSE-placebo), Group II (placebo-BSSE), Group III (BSSE, acetaminophen) |
| Placebo AdministrationGiven PO | Drug | Group I (BSSE-placebo), Group II (placebo-BSSE), Group IV (placebo, acetaminophen) |
| Questionnaire AdministrationAncillary studies | Other | Group I (BSSE-placebo), Group II (placebo-BSSE), Group III (BSSE, acetaminophen), Group IV (placebo, acetaminophen) |
| TrainingAlso: Training ProgramsUndergo flashover training | Other | Group I (BSSE-placebo), Group II (placebo-BSSE) |
Primary outcome
Change in total amount of acetaminophen mercapturate excreted in the urine
Time frame: Baseline to end-of-intervention
Will compare after acetaminophen dosing between broccoli seed and sprout extract (BSSE) and placebo arms. Will be quantified by liquid chromatography tandem mass spectrometry. Log-transformation will be applied to total amount of acetaminophen mercapturate before deriving the changes at the end of intervention from baseline since the total amount of acetaminophen mercapturate may be highly right skewed. Even if the total amount of acetaminophen mercapturate is not highly right skewed, log-transformation will also allow comparison of the relative percent change in total amount of acetaminophen mercapturate at the end of intervention from baseline between the BSSE and placebo groups through use of the geometric mean of total amount of acetaminophen mercapturate. Will be analyzed in participants who initiated treatment and provided both pre-study agent intervention and post-study agent intervention urine.
3 secondary outcomes
Change in total amount of acetaminophen glucuronide excreted in the urine
Time frame: Baseline to end-of-intervention
Incidence of adverse events
Time frame: Start of intervention to follow-up
Adherence rate
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malvi Savani principal investigator
University of Arizona Cancer Center - Prevention Research Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetaminophen, Biospecimen Collection and Broccoli Sprout/Broccoli Seed Extract Supplement in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total amount of acetaminophen mercapturate excreted in the urine (time frame: Baseline to end-of-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.