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

NCT02075112 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-12-06

No results posted yet for this study

Summary

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

  • Cancer of Head and Neck

Interventions

DRUG

Soy isoflavone

Patients will receive genistein 150 mg daily for the duration of radiation treatment. If a patient is experiencing significant side effects attributable to genistein, the treating physician has the option to reduce genistein to 150 mg every other day.

RADIATION

Radiation

All patients will undergo computed tomography (CT) simulation with intravenous (IV) contrast unless medical contraindications to IV contrast exist. Gross disease will be treated to 70 Gy in 2 Gy/day.

DRUG

Cisplatin

Cisplatin chemotherapy 100 mg/m² on days 1, 22, and 43 of radiation treatment.

Sponsors & Collaborators

  • Radiation Therapy Oncology Group

    collaborator NETWORK

  • Emory University

    lead OTHER

Principal Investigators

  • Kristin Higgins, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02075112 on ClinicalTrials.gov