Preoperative Soy Isoflavone Supplementation in the Prevention of Head and Neck Squamous Carcinoma
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Purpose
We hypothesize that p16 hypermethylation in tumor and adjacent non-tumor mucosa identifies patients who have impaired response to stress signals associated with smoking, and that p16 hypermethylation and associated over expression of downstream targets such as COX-2, VEGF, EGFR and IL6 can be abrogated by soy isoflavone supplementation.
| Condition | Intervention | Phase |
|---|---|---|
|
Squamous Carcinoma |
Drug: Soy Isoflavone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Preoperative Soy Isoflavone Supplementation and Molecular Markers in the Prevention of Head and Neck Squamous Carcinoma |
- Determine if preoperative (300 mg/day x 21 days) soy isoflavone modulates p16 methylation and expression of p16, COX-2, VEGF, EGFR, IL6, p53 and Bcl-xL in tumor/non-tumor mucosa in patients with head/neck squamous carcinoma undergoing tumor resection. [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
- toxicity of short-term, preoperative treatment with soy isoflavone. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- overall and relapse-free survival. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Soy isoflavone treatment arm
A three week administration of moderate (300 mg daily) dose soy isoflavone
|
Drug: Soy Isoflavone
Dosage - 300 mg/day Route of Administration - oral Frequency - 2, 150 mg capsules daily with food for 21 doses
Other Name: PTI G-2535 (unconjugated isoflavones - 70)
|
Detailed Description:
The overall long term goal of the proposed research is to determine if administration of a soy isoflavone will provide a basis for secondary prevention and cancer control that can decrease tumor recurrence and increase overall survival and quality of life in patients with head and neck squamous carcinoma. Secondarily, we hope to identify candidate genes and intermediate endpoints for future primary prevention trials. The inclusion of Karmanos Cancer Institute and Emory University will provide additional new patient accrual and improved access to minority patients.
We will conduct a Phase II trial to determine whether short term (3 weeks) soy isoflavone administration can modulate p16 methylation and tissue expression of p53, p16, EGFR, VEGF, Bcl-xL and COX-2 in resected specimens and adjacent non-tumor mucosa to potentially identify markers useful as intermediate endpoints and define how quickly changes in gene markers might be seen. Correlation of pretreatment tissue markers with serum and saliva markers will be determined to identify potential surrogates of tissue markers that could be useful in serial monitoring protocols in patients or high risk populations with oral leukoplakia or dysplasia where serial tumor specimens are not available. This protocol is designed to provide a comprehensive assessment of adjuvant soy isoflavone and molecular markers in a prospective clinical trial setting. Accrual will be enhanced by the addition of Karmanos Cancer Institute and Emory University.
Eligibility| Ages Eligible for Study: | 19 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have pathologically-confirmed, resectable, squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx.
- Disease must be Stage I, II, III or IVa.
- Tumor must be potentially surgically resectable and curable with conventional surgery and radiation therapy.
- ECOG Performance status 0-2 (See Appendix A).
- Patients must give documented informed consent to participate in this study.
- Age greater than 18 or less than 80.
Exclusion Criteria:
- Documented evidence of distant metastases.
- Ongoing acute medical condition such as uncontrolled coronary artery disease, emphysema, or diabetes mellitus that would preclude surgical resection.
- Pregnancy or lactation. Patients of child bearing age must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of soy administration.
- A medical or psychiatric illness which would compromise the patient's ability to tolerate this treatment or comply with administration of study drug.
- Patients residing in prison.
- Any patients with a history of breast or ovarian cancer.
- Allergy to soy products.
Contacts and Locations| Contact: Gregory T Wolf, M.D. | 734 936 8029 | gregwolf@med.umich.edu |
| Contact: Cancer AnswerLine | 1-800-865-1125 | canceranswerline@umich.edu |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109-2800 | |
| Contact: Gregory T Wolf, MD 734-936-9178 Gregwolf@med.umich.edu | |
| Contact: Cancer AnswerLine 1-800-865-1125 canceranswerline@umich.edu | |
| Principal Investigator: Gregory T Wolf, MD | |
| Principal Investigator: | Gregory T. Wolf, MD, FACS | University of Michigan Cancer Center |
More Information
No publications provided
| Responsible Party: | Gregory Wolf, M.D., Principal Investigator, University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01028001 History of Changes |
| Other Study ID Numbers: | UMCC 2009.008, HUM%26957 |
| Study First Received: | December 8, 2009 |
| Last Updated: | February 20, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Michigan Cancer Center:
|
Stage I, II, III or IVa squamous cell carcinoma oral cavity oropharynx larynx |
hypopharynx resectable Head and Neck Squamous Carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |
ClinicalTrials.gov processed this record on June 13, 2013