Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT02007200
First received: December 4, 2013
Last updated: September 1, 2016
Last verified: September 2016
Results First Received: July 7, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Laryngeal Verrucous Carcinoma
Recurrent Lip and Oral Cavity Squamous Cell Carcinoma
Recurrent Oral Cavity Verrucous Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
Stage I Hypopharyngeal Squamous Cell Carcinoma
Stage I Laryngeal Squamous Cell Carcinoma
Stage I Laryngeal Verrucous Carcinoma
Stage I Lip and Oral Cavity Squamous Cell Carcinoma
Stage I Oral Cavity Verrucous Carcinoma
Stage I Oropharyngeal Squamous Cell Carcinoma
Stage II Hypopharyngeal Squamous Cell Carcinoma
Stage II Laryngeal Squamous Cell Carcinoma
Stage II Laryngeal Verrucous Carcinoma
Stage II Lip and Oral Cavity Squamous Cell Carcinoma
Stage II Oral Cavity Verrucous Carcinoma
Stage II Oropharyngeal Squamous Cell Carcinoma
Stage III Hypopharyngeal Squamous Cell Carcinoma
Stage III Laryngeal Squamous Cell Carcinoma
Stage III Laryngeal Verrucous Carcinoma
Stage III Lip and Oral Cavity Squamous Cell Carcinoma
Stage III Oral Cavity Verrucous Carcinoma
Stage III Oropharyngeal Squamous Cell Carcinoma
Stage IV Hypopharyngeal Squamous Cell Carcinoma
Stage IVA Laryngeal Squamous Cell Carcinoma
Stage IVA Laryngeal Verrucous Carcinoma
Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma
Stage IVA Oral Cavity Verrucous Carcinoma
Stage IVA Oropharyngeal Squamous Cell Carcinoma
Tongue Carcinoma
Interventions: Other: Laboratory Biomarker Analysis
Drug: Soy Isoflavones
Other: Survey Administration

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Soy Isoflavones)

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

55 patients were enrolled. 3 of these patients did not receive treatment.


Participant Flow:   Overall Study
    Treatment (Soy Isoflavones)
STARTED   55 
COMPLETED   55 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Treatment (Soy Isoflavones) Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.

Baseline Measures
   Treatment (Soy Isoflavones) 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Years]
Mean (Full Range)
 60 
 (26 to 78) 
Gender 
[Units: Participants]
 
Female   12 
Male   27 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF   [ Time Frame: Up to 12 months ]

3.  Secondary:   The Number of Participants Alive at Follow-up   [ Time Frame: Up to 24 months ]

4.  Secondary:   The Number of Participants Alive Without Relapse at Last Follow-up   [ Time Frame: Up to 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gregory T. Wolf, M.D.
Organization: University of Michigan Comprehensive Cancer Center
phone: 800-865-1125
e-mail: gregwolf@umich.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02007200     History of Changes
Obsolete Identifiers: NCT01028001
Other Study ID Numbers: NCI-2011-03618
NCI-2011-03618 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
UMCC 2009.008 ( Other Identifier: University of Michigan Comprehensive Cancer Center )
UMCC 2009.008 ( Other Identifier: DCP )
P30CA046592 ( US NIH Grant/Contract Award Number )
Study First Received: December 4, 2013
Results First Received: July 7, 2016
Last Updated: September 1, 2016
Health Authority: United States: Food and Drug Administration