NCT02007200 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2016-10-24

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

The Number of Participants Alive at Follow-up

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * 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 Exclusion Criteria: * 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
healthy Volunteers: false
maximum Age: 79 Years
minimum Age: 19 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
intervention Names
Other: Laboratory Biomarker Analysis
Drug: Soy Isoflavones
Other: Survey Administration
label
Treatment (soy isoflavones)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (soy isoflavones)
description
Correlative studies
name
Laboratory Biomarker Analysis
type
OTHER
arm Group Labels
Treatment (soy isoflavones)
description
Given PO
name
Soy Isoflavones
other Names
NovaSoy
Solgen 40
Soy Isoflavone
Soybean Isoflavone Mixture
type
DRUG
arm Group Labels
Treatment (soy isoflavones)
description
Ancillary studies
name
Survey Administration
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 55
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
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
description
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.
measure
Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF
time Frame
Up to 12 months

secondary Outcomes

description
Overall survival at last follow-up will be determined.
measure
The Number of Participants Alive at Follow-up
time Frame
Up to 24 months
description
Relapse-free survival will be determined at the last follow-up visit.
measure
The Number of Participants Alive Without Relapse at Last Follow-up
time Frame
Up to 24 months

Full study description

brief 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.
detailed Description: PRIMARY OBJECTIVES: I. 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: I. 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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice