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Botanical Agent

Anti-tumor B for Cancer

Phase < 1
Recruiting
Led By Stuart J Wong, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate renal and hepatic function within 14 calendar days prior to registration, defined as follows: Serum creatinine < 1.5 mg/dl or creatinine clearance (CCr) ≥ 50 ml/min within 14 calendar days prior to registration, determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CrCl male) Total bilirubin < 2 x the institutional upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x the institutional ULN; Magnesium, calcium, glucose, potassium, and sodium within 14 calendar days prior to registration, with the following required parameters: Magnesium: > 0.9 mg/dl or < 3 mg/dl; Calcium: > 7 mg/dl or < 12.5 mg/dl; Glucose: > 40 mg/dl or < 250 mg/dl; Potassium: > 3 mmol/L or < 6 mmol/L; Sodium: > 130 mmol/L or < 155 mmol/L. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
History and physical examination by an otolaryngologist and medical oncologist within 14 calendar days of study registration.
Must not have
Severe active comorbidity, such as uncontrolled cardiac disease, infection, and severe chronic obstructive pulmonary disease (COPD).
Concurrent use of any medicinal botanical, natural, or other herbal compounds.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and after surgery (seven to 28 days after baseline)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a botanical agent called Anti-tumor B to see if it can shrink tumors. The study is comparing it to a placebo (fake treatment) to see if it is effective.

Who is the study for?
Adults over 18 with a new or recurring oral cavity squamous cell cancer, who haven't had systemic chemotherapy for it. They must be fit for surgery and have good organ function. Women of childbearing age must use contraception, and men agree to barrier methods or abstinence.
What is being tested?
The trial is testing Anti-tumor B, made from six Chinese herbs, against a placebo in patients with oral cancer. It's randomized and double-blinded, meaning neither the doctors nor the patients know who gets the real treatment versus the placebo.
What are the potential side effects?
Potential side effects are not specified but could include reactions related to herbal compounds such as allergies, gastrointestinal issues or interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been examined by an ear, nose, and throat doctor and a cancer specialist within the last 14 days.
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My cancer is at a stage where surgery is possible.
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I have been diagnosed with squamous cell cancer in my mouth.
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I have had surgery to remove my uterus and/or both ovaries.
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I have been postmenopausal for at least one year.
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I can take care of myself and am up and about more than half of my waking hours.
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I can carry out all self-care but cannot 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 do not have severe health issues like uncontrolled heart disease or severe lung problems.
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I am currently using herbal or natural remedies.
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I am not scheduled for partial tumor removal surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and after surgery (seven to 28 days after baseline)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and after surgery (seven to 28 days after baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of Ki-67 positive cells

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Anti-tumor BExperimental Treatment1 Intervention
1,200 mg three times a day.

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
635 Previous Clinical Trials
1,181,688 Total Patients Enrolled
Stuart J Wong, MDPrincipal InvestigatorMedical College of Wisconsin
1 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Anti-tumor B (Botanical Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04278989 — Phase < 1
Squamous Cell Carcinoma Research Study Groups: Anti-tumor B
Squamous Cell Carcinoma Clinical Trial 2023: Anti-tumor B Highlights & Side Effects. Trial Name: NCT04278989 — Phase < 1
Anti-tumor B (Botanical Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04278989 — Phase < 1
~1 spots leftby Mar 2025
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