Broccoli Sprout Extract in Preventing Recurrence in Patients With Tobacco-Related Head and Neck Squamous Cell Cancer
NCT03182959 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2021-06-21
Summary
This study is being done to see whether Avmacol®, a dietary supplement made from broccoli sprout and seed extract powder, induces changes in inner cheek cells that may be protective against environmental toxins such as tobacco.
There are three main goals of the study:
1. To learn whether the dietary supplement, Avmacol®, can stimulate cheek cells to repair damage from environmental toxins;
2. to learn how the body metabolizes Avmacol®, by measuring its byproducts in the participant's urine and blood;
3. to learn whether the immune system can be stimulated by Avmacol®, by studying the natural killer cells and T cells in the participant's blood.
Conditions
- HNSCC
- Head and Neck Cancer
- Head and Neck Squamous Cell Carcinoma
- Tobacco-Related Carcinoma
- Carcinoma in Situ
- Dysplasia
- Hyperplasia
- Premalignant Lesion
Interventions
- DRUG
-
Avmacol®
Avmacol® tablets
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of Arizona
lead OTHER
Principal Investigators
-
Julie E. Bauman, MD, MPH · The University of Arizona
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-24
- Primary Completion
- 2020-01-01
- Completion
- 2021-01-19
- FDA Drug
- Yes
Countries
- United States
Study Locations
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