At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 55 enrolled
Drug / intervention
Soy Isoflavones +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Preoperative Soy Isoflavone Supplementation and Molecular Markers in the Prevention of Head and Neck Squamous Carcinoma
In Brief
A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Soy Isoflavones, and 1 other intervention for Recurrent Hypopharyngeal Squamous Cell Carcinoma and 30 related conditions. Completed, enrolled 55 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Laryngeal Verrucous Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma, Recurrent Oral Cavity Verrucous Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Stage I Hypopharyngeal Squamous Cell Carcinoma, Stage I Laryngeal Squamous Cell Carcinoma, Stage I Laryngeal Verrucous Carcinoma, Stage I Lip and Oral Cavity Squamous Cell Carcinoma, Stage I Oral Cavity Verrucous Carcinoma, Stage I Oropharyngeal Squamous Cell Carcinoma, Stage II Hypopharyngeal Squamous Cell Carcinoma, Stage II Laryngeal Squamous Cell Carcinoma, Stage II Laryngeal Verrucous Carcinoma, Stage II Lip and Oral Cavity Squamous Cell Carcinoma, Stage II Oral Cavity Verrucous Carcinoma, Stage II Oropharyngeal Squamous Cell Carcinoma, Stage III Hypopharyngeal Squamous Cell Carcinoma, Stage III Laryngeal Squamous Cell Carcinoma, Stage III Laryngeal Verrucous Carcinoma, Stage III Lip and Oral Cavity Squamous Cell Carcinoma, Stage III Oral Cavity Verrucous Carcinoma, Stage III Oropharyngeal Squamous Cell Carcinoma, Stage IV Hypopharyngeal Squamous Cell Carcinoma, Stage IVA Laryngeal Squamous Cell Carcinoma, Stage IVA Laryngeal Verrucous Carcinoma, Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVA Oral Cavity Verrucous Carcinoma, Stage IVA Oropharyngeal Squamous Cell Carcinoma, Tongue Carcinoma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedDec 2013
Primary CompletionSep 2015
TodayJul 2026
First PostedDec 10, 2013
Enrollment StartJul 1, 2009
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 12.6 years ago
Interventions
Laboratory Biomarker Analysisother
Correlative studies
Soy Isoflavonesdrug
Given PO
Survey Administrationother
Ancillary studies