Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC of the Head and Neck

Emory University

Status and phase

Completed

Phase 1

Conditions

Cancer of Head and Neck

Treatments

Radiation: Radiation

Drug: Cisplatin

Drug: Soy isoflavone

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT02075112

IRB00065591

RAD2412-13 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Concurrent chemoradiation is the standard of care for locally advanced squamous cell carcinoma of the head and neck (SCCHN). Improving the outcome for patients with this disease remains a major challenge.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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