Cancer of Head and NeckPhase 1NCT02075112
Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC of the Head and Neck
A Phase 1 study testing Soy isoflavone, Radiation and Cisplatin in people with Cancer of Head and Neck, run by Emory University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Head and Neck
- What is being tested?
- Soy isoflavone, Radiation and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2013to Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Cancer of Head and Neck
- Keywords
- Soy, Isoflavone, Radiation Therapy, Cisplatin
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy isoflavoneDrug
Also called Genistein
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.
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.
CisplatinDrug
Also called Platinol
Cisplatin chemotherapy 100 mg/m² on days 1, 22, and 43 of radiation treatment.
| Study group | Role | What they receive |
|---|---|---|
| Soy isoflavone | Experimental | Study treatment: Soy isoflavone in combination with radiation therapy \& cisplatin Receives: Drug: Soy isoflavone; Radiation: Radiation; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after treatment completion
Secondary outcomes (3)
Exploratory biomarker studies: changes in interleukin 6
Serum baseline levels of interleukin 6 (IL6) and their levels at 3 and 6 months post-treatment.
Measured: 3 and 6 months post-treatment
Exploratory biomarker studies: changes in vascular endothelial growth factor
Serum baseline levels of vascular endothelial growth factor (VEGF) and their levels at 3 and 6 months post-treatment.
Measured: 3 and 6 months post-treatment
Exploratory biomarker studies: changes in isoprostanes levels
Baseline urinary levels of isoprostanes before treatment, and 3 and 6 months post-treatment, as a potential marker of oxidative stress associated with chemoradiation.
Measured: 3 and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Radiation Therapy Oncology Group
- Responsible party
- Principal investigator, Kristin Higgins, MD, Emory University
- Investigators
- Kristin Higgins, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075112
- Sponsor's protocol ID
- IRB00065591
- Other IDs
- RAD2412-13
- Status last verified
- Dec 2019
- First submitted
- 12 Feb 2014
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02075112
- Acronym / sponsor ID
- IRB00065591
- Conditions
- Cancer of Head and Neck
- Keywords
- Soy, Isoflavone, Radiation Therapy, Cisplatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Radiation Therapy Oncology Group
- Study start
- Nov 2013
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Soy isoflavone | Experimental | Drug: Soy isoflavone, Radiation: Radiation, Drug: CisplatinStudy treatment: Soy isoflavone in combination with radiation therapy \& cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy isoflavoneAlso: GenisteinPatients 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. | Drug | Soy isoflavone |
| RadiationAll 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. | Radiation | Soy isoflavone |
| CisplatinAlso: PlatinolCisplatin chemotherapy 100 mg/m² on days 1, 22, and 43 of radiation treatment. | Drug | Soy isoflavone |
Primary outcome
Percentage of patients with grade 2 or higher xerostomia at 1 year post-treatment
Time frame: 1 year after treatment completion
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.
3 secondary outcomes
Exploratory biomarker studies: changes in interleukin 6
Time frame: 3 and 6 months post-treatment
Exploratory biomarker studies: changes in vascular endothelial growth factor
Time frame: 3 and 6 months post-treatment
Exploratory biomarker studies: changes in isoprostanes levels
Time frame: 3 and 6 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Higgins, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Soy isoflavone, Radiation and Cisplatin in people with Cancer of Head and Neck, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with grade 2 or higher xerostomia at 1 year post-treatment (time frame: 1 year after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.