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Recurrent Hypopharyngeal Squamous Cell CarcinomaPhase 2NCT02007200

Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery

A Phase 2 study testing Laboratory Biomarker Analysis, Soy Isoflavones and Survey Administration in people with Recurrent Hypopharyngeal Squamous Cell Carcinoma and Recurrent Laryngeal Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II clinical trial studies how well soy isoflavones work in preventing head and neck cancer in patients with stage I-IV head and neck cancer undergoing surgery. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy isoflavones may prevent head and neck cancer recurrence. Read more about this study

Who is it for?
Ages 19 to 79 years
What is being tested?
Laboratory Biomarker Analysis, Soy Isoflavones and Survey Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
3 sitesUnited States
Study dates
Jul 2009to Sep 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 19 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have pathologically-confirmed, resectable, squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
  • Disease must be Stage I, II, III or IVa
  • Tumor must be potentially surgically resectable and curable with conventional surgery and radiation therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
  • Patients must give documented informed consent to participate in this study

Who cannot join

  • Documented evidence of distant metastases
  • Ongoing acute medical condition such as uncontrolled coronary artery disease, emphysema, or diabetes mellitus that would preclude surgical resection
  • Pregnancy or lactation; patients of child bearing age must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of soy administration
  • A medical or psychiatric illness which would compromise the patient's ability to tolerate this treatment or comply with administration of study drug
  • Patients residing in prison
  • Any patient with a history of breast or ovarian cancer
  • Allergy to soy products

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

Other trials in United States

About this study

Official title: A Phase II Trial of Preoperative Soy Isoflavone Supplementation and Molecular Markers in the Prevention of Head and Neck Squamous Carcinoma

This phase II clinical trial studies how well soy isoflavones work in preventing head and neck cancer in patients with stage I-IV head and neck cancer undergoing surgery. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy isoflavones may prevent head and neck cancer recurrence.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine if short term, preoperative (300 mg/day x 14 treatment days) soy isoflavone supplementation modulates p16 methylation (% CpG sites methylated) and expression of p16, cyclooxygenase 2 [COX-2], vascular endothelial growth factor receptor [VEGF], epidermal growth factor receptor [EGFR], interleukin-6 [IL6], p53 and B-cell lymphoma-extra large [Bcl-xL] in tumor and non-tumor adjacent mucosa of patients with head and neck squamous carcinoma undergoing curative tumor resection.

II. To estimate correlations of tumor p16 methylation (% CpG sites methylated) with expression of p16 and levels of, IL6, VEGF, and 15-F2t-isoprostane in serum and saliva.

SECONDARY OBJECTIVES:

  1. Describe the toxicity of short-term, preoperative treatment with soy isoflavone.

II. To determine overall and relapse-free survival.

OUTLINE:

Patients receive soy isoflavones orally (PO) for approximately 14 days before undergoing surgery.

After completion of treatment, patients are followed up, within the routine cancer management schedule, at 3, 6, 12, and 24 months.

Being tested
Laboratory Biomarker Analysis, Soy Isoflavones, Survey Administration
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Lymphoid Interstitial Pneumonia, Tongue Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Soy IsoflavonesDrug

    Also called NovaSoy, Solgen 40, Soy Isoflavone, Soybean Isoflavone Mixture

    Given PO

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT02007200
Study groupRoleWhat they receive
Treatment (soy isoflavones)ExperimentalPatients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
Receives: Other: Laboratory Biomarker Analysis; Drug: Soy Isoflavones; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone

    The change in methylation will be analyzed in parallel using a linear repeated measures model. The fixed effects will be time (pre-treatment versus post-treatment), current smoking status (yes or no), their interaction, and tissue type (tumor or not). Satterthwaite's adjustment to the degrees of freedom will be applied to account for heteroscedasticity. The differential effect of soy isoflavone on tumor and non-tumor tissues between smokers and non-smokers will be assessed using linear contrasts.

    Measured: From baseline to surgery, up to 42 days

  2. Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF

    Each of the tumor and mucosal markers will be dependent variables in repeated measures models that include serum and saliva markers as predictors. Graphical analyses will be used to characterize possible nonlinear relationships between variables. Linear or nonlinear regression, as appropriate, will be used to characterize the relationship between the putative predictors and outcomes. Subset analyses, considering, for example, differences in relationships between tumor markers and serum and saliva markers between smokers and non-smokers will be performed by means of indicator variables.

    Measured: Up to 12 months

Secondary outcomes (2)

  1. The Number of Participants Alive at Follow-up

    Overall survival at last follow-up will be determined.

    Measured: Up to 24 months

  2. The Number of Participants Alive Without Relapse at Last Follow-up

    Relapse-free survival will be determined at the last follow-up visit.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2013 (estimated)
  2. Study startJul 2009
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02007200
Sponsor's protocol ID
NCI-2011-03618
Other IDs
NCI-2011-03618, UMCC 2009.008, UMCC 2009.008, P30CA046592
Status last verified
Sep 2016
First submitted
4 Dec 2013
Last updated
24 Oct 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laboratory Biomarker Analysis, Soy Isoflavones and Survey Administration in people with Recurrent Hypopharyngeal Squamous Cell Carcinoma and Recurrent Laryngeal Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 3 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 5 inclusion and 7 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 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone (time frame: From baseline to surgery, up to 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02007200.

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 24 Oct 2016.

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