Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery
A Phase II Trial of Preoperative Soy Isoflavone Supplementation and Molecular Markers in the Prevention of Head and Neck Squamous Carcinoma
3 other identifiers
interventional
55
1 country
3
Brief Summary
This phase II clinical trial studies how well soy isoflavones work in preventing head and neck cancer in patients with stage I-IV head and neck cancer undergoing surgery. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy isoflavones may prevent head and neck cancer recurrence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2009
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 4, 2013
CompletedFirst Posted
Study publicly available on registry
December 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
October 24, 2016
CompletedOctober 24, 2016
September 1, 2016
6.2 years
December 4, 2013
July 7, 2016
September 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone
The change in methylation will be analyzed in parallel using a linear repeated measures model. The fixed effects will be time (pre-treatment versus post-treatment), current smoking status (yes or no), their interaction, and tissue type (tumor or not). Satterthwaite's adjustment to the degrees of freedom will be applied to account for heteroscedasticity. The differential effect of soy isoflavone on tumor and non-tumor tissues between smokers and non-smokers will be assessed using linear contrasts.
From baseline to surgery, up to 42 days
Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF
Each of the tumor and mucosal markers will be dependent variables in repeated measures models that include serum and saliva markers as predictors. Graphical analyses will be used to characterize possible nonlinear relationships between variables. Linear or nonlinear regression, as appropriate, will be used to characterize the relationship between the putative predictors and outcomes. Subset analyses, considering, for example, differences in relationships between tumor markers and serum and saliva markers between smokers and non-smokers will be performed by means of indicator variables.
Up to 12 months
Secondary Outcomes (2)
The Number of Participants Alive at Follow-up
Up to 24 months
The Number of Participants Alive Without Relapse at Last Follow-up
Up to 24 months
Study Arms (1)
Treatment (soy isoflavones)
EXPERIMENTALPatients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
Interventions
Given PO
Eligibility Criteria
You may qualify if:
- 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
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- Patients must give documented informed consent to participate in this study
You may not qualify if:
- 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 patient with a history of breast or ovarian cancer
- Allergy to soy products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gregory T. Wolf, M.D.
- Organization
- University of Michigan Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Greg Wolf
University of Michigan Rogel Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2013
First Posted
December 10, 2013
Study Start
July 1, 2009
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
October 24, 2016
Results First Posted
October 24, 2016
Record last verified: 2016-09