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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and after surgery (seven to 28 days after baseline)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of Ki-67 positive cells

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
610 Previous Clinical Trials
1,162,699 Total Patients Enrolled
Stuart J Wong, MDPrincipal InvestigatorMedical College of Wisconsin
1 Previous Clinical Trials
65 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor actively enrolling participants?

"Affirmative. Clinicaltrials.gov has information that suggests this medical study is now recruiting people interested in participating. The trial was introduced on April 22nd 2022, and a recent update to the posting occurred on the same date. 28 participants need to be recruited from just one centre for the trial's completion."

Answered by AI

How many participants are being investigated as part of this research endeavor?

"Affirmative. The information on clinicaltrials.gov attests that this scientific research project, initially posted April 22nd 2022 is presently recruiting patients. Twenty-eight participants are required across a single center."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Inhibition of Oral Tumorigenesis by Antitumor B
Stuart Wong 2022. "Inhibition of Oral Tumorigenesis by Antitumor B". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04278989.
~2 spots leftby Sep 2024
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