Clinical trial · Interventional
Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC of the Head and Neck
A Pilot Study of Soy Isoflavone, Genistein, in Combination With Radiation Therapy and Cisplatin in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- 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)
The purpose of this study is to determine if soy supplementation during chemotherapy and radiation therapy will decrease side effects caused by treatment. Long-lasting dry mouth is a side effect of the standard treatment, and we are testing whether soy supplementation during treatment may reduce this symptom and other side effects of chemoradiation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Radiation | Radiation | — | UNRESOLVED |
| Soy isoflavone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Soy isoflavone
- description
- Study treatment: Soy isoflavone in combination with radiation therapy \& cisplatin
- interventionNames
- Drug: Soy isoflavone
- Radiation: Radiation
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Percentage of patients with grade 2 or higher xerostomia at 1 year post-treatment
- timeFrame
- 1 year after treatment completion
- description
- The primary outcome of this study is the percentage of patients with symptomatic (grade 2 or higher) xerostomia at 1 year post-treatment, assessed by the Late Effects of Normal Tissues (LENT)/Subjective, Objective, Management, Analytic (SOMA) method.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven squamous cell carcinoma of the head and neck (SCCHN) * Primary disease site involving the oropharynx * Clinical stage III or IV * Age ≥ 18 * Karnofsky Performance Status (KPS) ≥ 70 * Adequate bone marrow, kidney, and hepatic function (no laboratory value \> 2 times the normal limit) * Amylase (0-160 U/L) and lipase (0-130 U/L) levels within 1.5 times the range of normal Exclusion Criteria: * Prior history of SCCHN * Prior history of radiation to the head and neck region * KPS \< 70 * Soy allergy * Contraindication to cisplatin chemotherapy or plans to alter or reduce cisplatin therapy * Any head and neck cancer of non-squamous histology * Any head and neck subsite other than oropharynx (including unknown primary site) * Patients who are pregnant or lactating * Patients who may benefit from surgical resection
References
Publications (0)
Data not yet available