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

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.

→

primary · POSTED

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.

We are seeking additional funding to hire the personnel to perform the serum/saliva markers. Until further notice markers will be unable to be analyzed.

→

secondary · POSTED

Overall survival at last follow-up will be determined.

55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.

→

secondary · POSTED

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

55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-oropharyngeal-cancer-stage-iv-recurrent-340d3d7c
nct id: NCT02007200
trial label: Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-oropharyngeal-cancer-stage-iv-recurrent-340d3d7c
nct id
NCT02007200
outcome key
om-0000
source section id
NCT02007200-om-0000
source outcome index
0
endpoint
Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone
endpoint definition
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.
time origin
From baseline to surgery, up to 42 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-oropharyngeal-cancer-stage-iv-recurrent-340d3d7c
nct id
NCT02007200
outcome key
om-0001
source section id
NCT02007200-om-0001
source outcome index
1
endpoint
Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF
endpoint definition
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.
time origin
Up to 12 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
We are seeking additional funding to hire the personnel to perform the serum/saliva markers. Until further notice markers will be unable to be analyzed.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-oropharyngeal-cancer-stage-iv-recurrent-340d3d7c
nct id
NCT02007200
outcome key
om-0002
source section id
NCT02007200-om-0002
source outcome index
2
endpoint
The Number of Participants Alive at Follow-up
endpoint definition
Overall survival at last follow-up will be determined.
time origin
Up to 24 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-oropharyngeal-cancer-stage-iv-recurrent-340d3d7c
nct id
NCT02007200
outcome key
om-0003
source section id
NCT02007200-om-0003
source outcome index
3
endpoint
The Number of Participants Alive Without Relapse at Last Follow-up
endpoint definition
Relapse-free survival will be determined at the last follow-up visit.
time origin
Up to 24 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-oropharyngeal-cancer-stage-iv-recurrent-340d3d7c
nct id
NCT02007200
outcome key
om-0000
arm key
OG000
arm label
Treatment (Soy Isoflavones)
regimen
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02007200-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-oropharyngeal-cancer-stage-iv-recurrent-340d3d7c
nct id
NCT02007200
outcome key
om-0001
arm key
OG000
arm label
Treatment (Soy Isoflavones)
regimen
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02007200-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-oropharyngeal-cancer-stage-iv-recurrent-340d3d7c
nct id
NCT02007200
outcome key
om-0002
arm key
OG000
arm label
Treatment (Soy Isoflavones)
regimen
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02007200-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-oropharyngeal-cancer-stage-iv-recurrent-340d3d7c
nct id
NCT02007200
outcome key
om-0003
arm key
OG000
arm label
Treatment (Soy Isoflavones)
regimen
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02007200-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-oropharyngeal-cancer-stage-iv-recurrent-340d3d7c
nct id
NCT02007200
harm key
EG000
source section id
NCT02007200-ae
event group key
EG000
event group label
Treatment (Soy Isoflavones)
serious affected
7
serious at risk
52
other affected
25
other at risk
52
frequency threshold
0
collection period
Source null
event definition
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice