Inhibition of Oral Tumorigenesis by Antitumor B
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|ClinicalTrials.gov Identifier: NCT04278989|
Recruitment Status : Not yet recruiting
First Posted : February 20, 2020
Last Update Posted : July 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Cancer of the Oral Cavity||Drug: Anti-tumor B Drug: Placebos||Early Phase 1|
One of the most promising chemopreventive agents to prevent head and neck cancer is Antitumor B (ATB), a Chinese herbal mixture.
This randomized Window of Opportunity trial will enroll patients with resectable stage I-IVB squamous cell cancer of the oral cavity who are candidates for surgical tumor resection. Participants will agree to allow a portion of the standard of care (diagnostic tumor biopsy) to be used for the study, and to take study agents or placebo for a duration (14 to 21 days) until the time of their surgery. A second, post-treatment tumor biopsy is not needed because the OR-resected tumor will serve this purpose.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Inhibition of Oral Tumorigenesis by Antitumor B|
|Estimated Study Start Date :||September 1, 2021|
|Estimated Primary Completion Date :||December 1, 2023|
|Estimated Study Completion Date :||December 1, 2024|
Active Comparator: Anti-tumor B
1,200 mg three times a day.
Drug: Anti-tumor B
1,200 mg, three times a day for seven to 28 days (dependent on scheduled surgery).
Placebo Comparator: Placebo
Placebo taken three times a day.
Placebos taken seven to 28 days (dependent on scheduled surgery).
- Tumor Ki-67 in baseline tumor biopsy compared to resected tumor. [ Time Frame: Baseline and following surgery (seven to 28 days after baseline) ]KI-67 will be measured as a change in the index from baseline to post-treatment (surgery).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278989
|Contact: Medical College of Wisconsin Cancer Center Clinical Trials Officefirstname.lastname@example.org|
|United States, Wisconsin|
|Froedtert Hospital & the Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Medical College of Wisconsin Cancer Center Trials Office 414-805-8900 email@example.com|
|Principal Investigator: Stuart J. Wong, MD|
|Principal Investigator:||Stuart J Wong, MD||Medical College of Wisconsin|