Clinical trial · Interventional
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
NCT02007200CI-TRIAL-00024395completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (31)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Hypopharyngeal Squamous Cell Carcinoma | Hypopharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Laryngeal Squamous Cell Carcinoma | Laryngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Laryngeal Verrucous Carcinoma | Laryngeal Verrucous Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Lip and Oral Cavity Squamous Cell Carcinoma | Lip and Oral Cavity Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Oral Cavity Verrucous Carcinoma | Oral Cavity Verrucous Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Oropharyngeal Squamous Cell Carcinoma | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage I Hypopharyngeal Squamous Cell Carcinoma | Hypopharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Soy Isoflavones | Drug | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (soy isoflavones)
- description
- Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Drug: Soy Isoflavones
- Other: Survey Administration
Primary outcomes (2)
- measure
- Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone
- timeFrame
- From baseline to surgery, up to 42 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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 * Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 * Patients must give documented informed consent to participate in this study 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 patient with a history of breast or ovarian cancer * Allergy to soy products
References
Publications (0)
Data not yet available
No reference posted for this study.