What side effects are associated with this type of intervention?

Common cancer treatments such as chemotherapy and radiation therapy often cause side effects including fatigue, nausea, vomiting, hair loss, and increased susceptibility to infections due to their impact on rapidly dividing cells. Targeted therapies, which aim at specific molecular targets, can lead to side effects like skin problems, hypertension, and liver issues. Natural or plant-based treatments, such as broccoli seed and sprout extracts, are being studied for their potential to detoxify and protect cells from damage, but high levels of intake may have off-target effects that require further investigation.

What prior FDA approvals exist?

The FDA has approved several drugs for cancer treatment, including targeted therapies like dabrafenib and trametinib for BRAF V600-mutant melanoma. These drugs work by inhibiting specific pathways involved in cancer cell growth. While there is ongoing research into natural phytochemicals like broccoli seed and sprout extract for their potential detoxification and cellular protection properties, these have not yet reached the stage of FDA approval for cancer treatment. Current approved treatments focus more on targeted molecular mechanisms rather than dietary supplements.

What other types of research exist?

Promising alternatives to Broccoli Seed and Sprout Extract for cancer patients include: 1) Omega-3 fatty acids, which have shown protective effects against chemotherapy-induced peripheral neuropathy; 2) Goshajinkigan, a Kampo medicine that has demonstrated efficacy in preventing chemotherapy-induced peripheral neuropathy; 3) Vitamin E, which has been studied for its neuroprotective effects in patients undergoing chemotherapy. These alternatives have shown potential in clinical trials and may offer benefits in detoxification and cellular protection.

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Phytochemical

Broccoli Extract for Tobacco-Related Cancer Risk

Phase 2

Recruiting

Led By Julie E Bauman

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

Must not have

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

Uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and 2, 4, 8, and 12 weeks

Summary

This trial tests if an extract from broccoli seeds and sprouts can help heavy smokers by removing harmful substances from their bodies and protecting their cells from damage. Sulforaphane, derived from broccoli seeds and sprouts, has been shown to induce detoxification enzymes and protect against cancer.

Who is the study for?

This trial is for adult heavy smokers with a significant smoking history who are generally healthy. They must have normal blood counts, liver and kidney function, and if HIV or hepatitis positive, they need controlled viral loads. Women of childbearing age and men must use birth control during the study.

What is being tested?

The trial is testing Avmacol ES (broccoli seed/sprout extract) to see if it helps break down harmful substances from tobacco in heavy smokers. Participants will either receive this supplement or a placebo while their biospecimens are collected for analysis.

What are the potential side effects?

Potential side effects aren't detailed but could include reactions similar to those allergic to compounds like Avmacol ES. Since its effect on fetuses is unknown, pregnant women can't participate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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My hepatitis B virus load is undetectable with treatment.

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I have smoked at least 20 pack-years and currently smoke 10 or more cigarettes a day.

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I am able to care for myself but may not be able to do active work.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I do not have any serious ongoing illnesses like heart failure or uncontrolled infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and 2, 4, 8, and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and 2, 4, 8, and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and 2, 4, 8, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Detoxification of benzene and acrolein

Secondary study objectives

Bioavailability of BSSE

Dose-response relationship between effective SF dose and the detoxification of benzene and acrolein

Genetic modulators of detoxification of tobacco carcinogens

+2 more

Other study objectives

Inflammation

Modulation of nasal epithelial gene signatures

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (broccoli seed and sprout extract)Experimental Treatment3 Interventions

Patients receive broccoli seed and sprout extract PO QD for 12 weeks in the absence of unacceptable toxicity. Patients undergo the collection of blood, nasal epithelial cell, and buccal cell samples throughout the study.

Group II: Group II (placebo)Active Control3 Interventions

Patients receive placebo PO QD for 12 weeks in the absence of unacceptable toxicity. Patients undergo the collection of blood, nasal epithelial cell, and buccal cell samples throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Broccoli Sprout/Broccoli Seed Extract Supplement

2018

Completed Early Phase 1

~50

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer treatments include chemotherapy, radiation therapy, surgery, and targeted therapies. Chemotherapy works by killing rapidly dividing cells, while radiation therapy uses high-energy particles to damage DNA in cancer cells. Surgery physically removes tumors, and targeted therapies block specific molecules involved in cancer growth. Treatments like broccoli seed and sprout extract focus on detoxification and cellular protection. They work by breaking down and removing carcinogens and protecting cells from damage through mechanisms like the inhibition of histone deacetylase (HDAC) activity. These mechanisms are crucial for cancer patients as they can reduce the toxic burden on the body and protect healthy cells, potentially improving treatment outcomes and reducing side effects.

Plant sprout foods: Biological activities, health benefits, and bioavailability.Sulforaphane retards the growth of human PC-3 xenografts and inhibits HDAC activity in human subjects.Protection against UV-light-induced skin carcinogenesis in SKH-1 high-risk mice by sulforaphane-containing broccoli sprout extracts.