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Effects of Avmacol® in the Oral Mucosa of Patients Following Curative Treatment for Tobacco-related Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT03268993
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Avmacol is an over-the-counter dietary supplement containing broccoli seed and sprout extracts in tablet form, hypothesized to activate protective cellular pathways including detoxication. In this study, participants who have been curatively treatment for head and neck cancer, will take Avmacol twice a day for 3 months

Condition or disease Intervention/treatment
Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Head and Neck Carcinoma Head and Neck Dietary Supplement: Avmacol

Detailed Description:
The broccoli seed preparation (BSP) Avmacol® results in acute and/or sustained induction of NRF2 target gene transcripts in the oral mucosa of patients who have been curatively treated for a tobacco-related HNSCC, including high grade dysplasia, carcinoma in situ, or invasive carcinoma. This study is not designed to examine the therapeutic or reparative effects of Avmacol® on premalignant lesions of the oral cavity.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 0 Study Evaluating the Systemic Bioavailability and Pharmacodynamic Effects of Avmacol® in the Oral Mucosa of Patients Following Curative Treatment for Tobacco-related Head and Neck Cancer
Actual Study Start Date : June 26, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Avmacol
You will be given a higher dose of Avmacol® each month, taking 2 Avmacol® tablets per day the first month (Cycle 1), 4 Avmacol® tablets per day the second month (Cycle 2), and 8 Avmacol® tablets per day the third month (Cycle 3). Investigators will study how Avmacol® affects your body by collecting three different tissues: 1) your cheek cells (buccal cells); 2) your urine; and 3) your blood. After you have finished three months of Avmacol®, you will return one month later for an end-of-study visit.
Dietary Supplement: Avmacol
Avmacol is a dietary supplement available over the counter
Other Name: broccoli see extract


Outcome Measures

Primary Outcome Measures :
  1. Protein Increase triggered by Inflammation [ Time Frame: 4 months ]
    Does Avmacol®, increase a type of protein in your body, which may protect against damage triggered by injury or inflammation. This will be measured by taking swabs of the inside of your mouth to determine protein increases.


Secondary Outcome Measures :
  1. NRF2 target protein expression is upregulated by Avmacol® in the oral mucosa. [ Time Frame: 4 months ]
    measured by the swabs taken from the inside of your mouth

  2. cytokine biomarkers of Avmacol® activity in serum, including IL8. [ Time Frame: 4 months ]
    measured via blood samples provided with participation in the study


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants must have completed curative-intent therapy (including surgery, radiation, and/or chemotherapy) for a first tobacco-related oral premalignant lesion (OPL) or HNSCC of any stage (eligible lesions include high grade dysplasia; carcinoma in situ; or stage I-IVa HNSCC).
  2. Primary site may include oral cavity, pharynx, or larynx. Oropharynx primaries must be HPV (-) as defined by routine p16 IHC at the local site.
  3. Participants may be enrolled between 3 months and 5 years AFTER completion of curative-intent therapy (including surgery, radiotherapy, and/or chemotherapy).
  4. Participants may have untreated OPLs (i.e., hyperplasia, dysplasia, carcinoma in situ) at the time of study entry, provided the index OPL or HNSCC was definitively treated.
  5. Participants must be at least 18 years old.
  6. Participants must have a Karnofsky Performance Status of 80% or higher or an ECOG of 0-1 (Appendix A)
  7. Current and former tobacco users are eligible. The tobacco use assessment form must be completed following consent, to assure eligibility (Appendix B). Patients must have ≥10 pack-year cumulative tobacco exposure or its equivalent to be eligible. This is defined as follows:

    1. Cigarette exposure: ≥10 pack-years OR
    2. Cigar exposure: ≥ 10 cigar-years, where 1 cigar year is defined as having smoked on average ≥ 1 cigar/day for a year OR
    3. Chewing tobacco: ≥10 snuff-years, where 1 snuff year is defined as using on average ≥ 1 pinch (dip) of chewing tobacco/day for a year.
  8. Able to perform written, informed consent.
  9. Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 Days prior to the first study intervention.
  10. WCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation.

Exclusion Criteria:

  • 1) Participants have a history of another malignancy within 2 years prior to starting study treatment, except for excised and cured carcinoma-in-situ of breast or cervix; non-melanomatous skin cancer; T1-2, N0, M0 differentiated thyroid carcinoma either resected or under active surveillance; superficial bladder cancer; T1a or T1b prostate cancer comprising < 5% of resected tissue with normal prostate specific antigen (PSA) since resection, or status post external beam radiation or brachytherapy with normal PSA since radiation.

    2) Primary oropharyngeal HNSCC which is HPV (+) as defined by p16 IHC. 3) Participants with acute intercurrent illness or those who had major surgery within the preceding 4 weeks unless they have fully recovered.

    4) Participants who have a positive pregnancy test, are pregnant, or breast feeding.

    5) Patients who are not practicing adequate contraception are ineligible if they are of child bearing potential.

    6) Patients currently using anti-neoplastic or anti-tumor agents, including chemotherapy, radiation therapy, immunotherapy, and hormonal anticancer therapy.

    7) Chronic anticoagulation with warfarin. Patients on low molecular weight heparin or fondaparinux may be enrolled.

    8) Chronic use of steroids at immunosuppressive doses. (Note, physiologic replacement doses of glucocorticoid or mineralocorticoid are acceptable, eg. prednisone 5-10 mg/day; fludrocortisone 0.1-0.2 mg/day.) 9) History of severe food intolerance to broccoli.

Contacts and Locations

Information from the National Library of Medicine

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): NCT03268993


Contacts
Contact: Seungwon Kim, MD 412 647 2117 kimsw2@upmc.edu
Contact: Carrie Muniz 412-623-6121 munizca@upmc.edu

Locations
United States, Pennsylvania
Eye and Ear Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Carrie Muniz    412-623-6121    munizca@upmc.edu   
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Carrie Muniz    412-623-6121    munizca@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Seungwon Kim, MD University of Pittsburgh
More Information

Responsible Party: Seungwon Kim, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03268993     History of Changes
Other Study ID Numbers: 15-203
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seungwon Kim, University of Pittsburgh:
prevention
dietary supplement
broccoli

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site