NCT03182959

Broccoli Sprout Extract in Preventing Recurrence in Patients With Tobacco-Related Head and Neck Squamous Cell Cancer

Completed EARLY_PHASE1 Last updated 21 June 2021

What this trial tests

EARLY_PHASE1 trial testing Avmacol® in HNSCC in 6 participants. Completed in 19 January 2021.

Timeline

24 April 2017

Primary endpoint
1 January 2020

19 January 2021

Quick facts

Lead sponsor	University of Arizona
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	6
Start date	24 April 2017
Primary completion	1 January 2020
Estimated completion	19 January 2021
Sites	1 location across United States

Drugs / interventions tested

• Avmacol® — full drug profile →

Conditions studied

• HNSCC — all drugs for HNSCC →
• Head and Neck Cancer — all drugs for Head and Neck Cancer →
• Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →
• Tobacco-Related Carcinoma — all drugs for Tobacco-Related Carcinoma →

Sponsor

University of Arizona

Who can join

18 and older, any sex, with HNSCC or Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Modulating NRF2 in Disease: Timing Is Everything.
   Dodson M, de la Vega MR, Cholanians AB, Schmidlin CJ, et al · · 2019 · cited 407× · PMID 30256716 · DOI 10.1146/annurev-pharmtox-010818-021856
2. Broccoli or Sulforaphane: Is It the Source or Dose That Matters?
   Yagishita Y, Fahey JW, Dinkova-Kostova AT, Kensler TW. · · 2019 · cited 209× · PMID 31590459 · DOI 10.3390/molecules24193593
3. Antioxidant Therapy in Cancer: Rationale and Progress.
   Luo M, Zhou L, Huang Z, Li B, et al · · 2022 · cited 109× · PMID 35740025 · DOI 10.3390/antiox11061128
4. Much More Than IL-17A: Cytokines of the IL-17 Family Between Microbiota and Cancer.
   Brevi A, Cogrossi LL, Grazia G, Masciovecchio D, et al · · 2020 · cited 81× · PMID 33244315 · DOI 10.3389/fimmu.2020.565470
5. The Regulatory Effect of Phytochemicals on Chronic Diseases by Targeting Nrf2-ARE Signaling Pathway.
   He WJ, Lv CH, Chen Z, Shi M, et al · · 2023 · cited 46× · PMID 36829795 · DOI 10.3390/antiox12020236
6. The Effects of Nuclear Factor Erythroid 2 (NFE2)-Related Factor 2 (Nrf2) Activation in Preclinical Models of Peripheral Neuropathic Pain.
   Basu P, Averitt DL, Maier C, Basu A. · · 2022 · cited 35× · PMID 35204312 · DOI 10.3390/antiox11020430
7. The Crosstalk between Autophagy and Nrf2 Signaling in Cancer: from Biology to Clinical Applications.
   Shan C, Wang Y, Wang Y. · · 2024 · cited 27× · PMID 39664581 · DOI 10.7150/ijbs.103187
8. Prospective Epigenetic Actions of Organo-Sulfur Compounds against Cancer: Perspectives and Molecular Mechanisms.
   Shoaib S, Ansari MA, Ghazwani M, Hani U, et al · · 2023 · cited 19× · PMID 36765652 · DOI 10.3390/cancers15030697