NCT02075112

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2013

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

December 6, 2019

Status Verified

December 1, 2019

Enrollment Period

5.8 years

First QC Date

February 12, 2014

Last Update Submit

December 5, 2019

Conditions

Cancer of Head and Neck

Keywords

SoyIsoflavoneRadiation TherapyCisplatin

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with grade 2 or higher xerostomia at 1 year post-treatment

    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.

    1 year after treatment completion

Secondary Outcomes (3)

  • Exploratory biomarker studies: changes in interleukin 6

    3 and 6 months post-treatment

  • Exploratory biomarker studies: changes in vascular endothelial growth factor

    3 and 6 months post-treatment

  • Exploratory biomarker studies: changes in isoprostanes levels

    3 and 6 months post-treatment

Study Arms (1)

Soy isoflavone

EXPERIMENTAL

Study treatment: Soy isoflavone in combination with radiation therapy \& cisplatin

Drug: Soy isoflavoneRadiation: RadiationDrug: Cisplatin

Interventions

Soy isoflavoneDRUG

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.

Also known as: Genistein
Soy isoflavone
RadiationRADIATION

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.

Soy isoflavone
CisplatinDRUG

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

Also known as: Platinol
Soy isoflavone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Soybean ProteinsGenisteinRadiationCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and BeveragesIsoflavonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPhysical PhenomenaChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Kristin Higgins, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2014

First Posted

March 3, 2014

Study Start

November 1, 2013

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

December 6, 2019

Record last verified: 2019-12

Locations

US(2)