Phase 2
Completed N=55
Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery
Source: ClinicalTrials.gov NCT02007200 ↗Enrolled (actual)
55
Serious AEs
13.5%
Results posted
Oct 2016
Primary outcomePrimary: Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone — 4.9 Percent change — p=<0.005
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone |
4.9 | <0.005 sig |
| PRIMARY Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF |
— | — |
| SECONDARY The Number of Participants Alive at Follow-up |
29 | — |
| SECONDARY The Number of Participants Alive Without Relapse at Last Follow-up |
24 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02007200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.