Trial Outcomes & Findings for Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery (NCT NCT02007200)
NCT ID: NCT02007200
Last Updated: 2016-10-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
From baseline to surgery, up to 42 days
Results posted on
2016-10-24
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery
Baseline characteristics by cohort
| Measure |
Treatment (Soy Isoflavones)
n=39 Participants
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
|
|---|---|
|
Age, Continuous
|
60 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to surgery, up to 42 daysPopulation: 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.
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.
Outcome measures
| Measure |
Treatment (Soy Isoflavones)
n=39 Participants
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
|
|---|---|
|
Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone
|
4.9 Percent change
Interval -34.8 to 20.9
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: 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.
Overall survival at last follow-up will be determined.
Outcome measures
| Measure |
Treatment (Soy Isoflavones)
n=39 Participants
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
|
|---|---|
|
The Number of Participants Alive at Follow-up
|
29 participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: 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.
Relapse-free survival will be determined at the last follow-up visit.
Outcome measures
| Measure |
Treatment (Soy Isoflavones)
n=39 Participants
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
|
|---|---|
|
The Number of Participants Alive Without Relapse at Last Follow-up
|
24 participants
|
Adverse Events
Treatment (Soy Isoflavones)
Serious events: 7 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Soy Isoflavones)
n=52 participants at risk
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
|
|---|---|
|
Cardiac disorders
Cardiopulmonary arrest, cause unknown (non-fatal)
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Infections and infestations
Infection, Lung
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Infections and infestations
Infection, Wound
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Musculoskeletal and connective tissue disorders
Pain, Bone
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
Other adverse events
| Measure |
Treatment (Soy Isoflavones)
n=52 participants at risk
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.8%
2/52 • Number of events 24
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.8%
3/52 • Number of events 4
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Blood and lymphatic system disorders
Platelets
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
9.6%
5/52 • Number of events 5
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
General disorders
Fever in the absence of neutropenia
|
1.9%
1/52 • Number of events 2
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
General disorders
Weight gain
|
7.7%
4/52 • Number of events 5
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
General disorders
Weight loss
|
5.8%
3/52 • Number of events 4
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Gastrointestinal disorders
Anorexia
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Gastrointestinal disorders
Constipation
|
3.8%
2/52 • Number of events 2
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
2/52 • Number of events 2
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
4/52 • Number of events 4
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Vascular disorders
Hemorrhage, Esophagus
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Vascular disorders
Hemorrhage, Oral Cavity
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Infections and infestations
Infection, Blood
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Infections and infestations
Infection, Neck NOS
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Infections and infestations
Infection - Other
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Infections and infestations
Infection, Skin (cellulitis)
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Vascular disorders
Edema: head and neck
|
3.8%
2/52 • Number of events 2
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Vascular disorders
Edema: limb
|
5.8%
3/52 • Number of events 3
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
9.6%
5/52 • Number of events 6
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Amylase
|
5.8%
3/52 • Number of events 4
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
5.8%
3/52 • Number of events 4
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
11.5%
6/52 • Number of events 11
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholestremia)
|
5.8%
3/52 • Number of events 4
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Creatinine
|
3.8%
2/52 • Number of events 2
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
19.2%
10/52 • Number of events 19
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Lipase
|
9.6%
5/52 • Number of events 5
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
5.8%
3/52 • Number of events 6
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
9.6%
5/52 • Number of events 6
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
5.8%
3/52 • Number of events 7
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
3.8%
2/52 • Number of events 2
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
5.8%
3/52 • Number of events 5
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
1.9%
1/52 • Number of events 2
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
7.7%
4/52 • Number of events 6
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
15.4%
8/52 • Number of events 10
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Musculoskeletal and connective tissue disorders
Extremity-upper (function)
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, Extraocular
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, facial
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, Whole Body
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Nervous system disorders
Confusion
|
1.9%
1/52 • Number of events 2
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Nervous system disorders
Mood alteration, Depression
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Nervous system disorders
Neurology - Other
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Nervous system disorders
Neuropathy: sensory
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Gastrointestinal disorders
Pain, Abdomen NOS
|
5.8%
3/52 • Number of events 3
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Musculoskeletal and connective tissue disorders
Pain, Back
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
General disorders
Pain, Face
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Nervous system disorders
Pain, Head
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Musculoskeletal and connective tissue disorders
Pain, Neck
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Gastrointestinal disorders
Pain, Oral
|
7.7%
4/52 • Number of events 4
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Gastrointestinal disorders
Pain, Throat
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
General disorders
Pain - Other
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
2/52 • Number of events 2
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
3.8%
2/52 • Number of events 2
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Surgical and medical procedures
Intra-operative injury
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
General disorders
Syndromes - Other
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
|
Vascular disorders
Vessel injury-vein
|
1.9%
1/52 • Number of events 1
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
|
Additional Information
Gregory T. Wolf, M.D.
University of Michigan Comprehensive Cancer Center
Phone: 800-865-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60