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Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT01867606
Recruitment Status : Active, not recruiting
First Posted : June 4, 2013
Results First Posted : April 1, 2020
Last Update Posted : October 23, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Female Reproductive Cancer
Interventions Biological: serum-derived bovine immunoglobulin protein isolate
Other: placebo
Other: laboratory biomarker analysis
Other: quality-of-life assessment
Other: questionnaire administration
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) Arm II (Placebo)
Hide Arm/Group Description

Patients receive SBI PO BID on days 1-28.>>

>> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.>>

>> serum-derived bovine immunoglobulin protein isolate: Given PO>>

>> laboratory biomarker analysis: Correlative studies>>

>> quality-of-life assessment: Ancillary studies>>

>> questionnaire administration: Ancillary studies

Patients receive placebo PO BID on days 1-28.>>

>> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.>>

>> placebo: Given PO>>

>> laboratory biomarker analysis: Correlative studies>>

>> quality-of-life assessment: Ancillary studies>>

>> questionnaire administration: Ancillary studies

Period Title: Overall Study
Started 26 32
Completed 16 17
Not Completed 10 15
Reason Not Completed
Withdrawal by Subject             10             14
Protocol Violation             0             1
Arm/Group Title Arm II (Placebo) Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) Total
Hide Arm/Group Description

Patients receive placebo PO BID on days 1-28.>>

>> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.>>

>> placebo: Given PO>>

>> laboratory biomarker analysis: Correlative studies>>

>> quality-of-life assessment: Ancillary studies>>

>> questionnaire administration: Ancillary studies

Patients receive SBI PO BID on days 1-28.>>

>> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.>>

>> serum-derived bovine immunoglobulin protein isolate: Given PO>>

>> laboratory biomarker analysis: Correlative studies>>

>> quality-of-life assessment: Ancillary studies>>

>> questionnaire administration: Ancillary studies

Total of all reporting groups
Overall Number of Baseline Participants 32 26 58
Hide Baseline Analysis Population Description
All enrolled patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 32 participants 26 participants 58 participants
62
(32 to 81)
62
(37 to 79)
62
(32 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 26 participants 58 participants
Female
32
 100.0%
26
 100.0%
58
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 26 participants 58 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
29
  90.6%
24
  92.3%
53
  91.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   9.4%
2
   7.7%
5
   8.6%
1.Primary Outcome
Title Time-to-QOL Improvement Defined as Any Increase in the QOL Score Measured Using the Total Score of the 14-item Postoperative Quality of Life (PQL) Tool
Hide Description For this endpoint, the total QOL score could range from 1 to 140 (0 being the worst and 140 being the best). The primary analysis will be a comparison of oral SBI vs. placebo using a two-sided log-rank test between the 2 Kaplan-Meier curves.the total score of the 14-item Postoperative Quality of Life (PQL) tool [15] will be used, where the total score could range from 0 to 140 (0 being the worst and 140 being the best). These scores will be converted to the percentage scale, where a score of 140 will be converted to 100 and a score of 0 will remain as 0. This QOL will be measured weekly for the entire 12 week length of the study and at the end of the intervention. QOL improvement will be defined as at least a 10 point increase in the QOL score from baseline, on the percentage scale.
Time Frame up to 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SBI PO BID on days 1-28. >

>

>

>

>

> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

>

>

>

>

>

> serum-derived bovine immunoglobulin protein isolate: Given PO

Patients receive placebo PO BID on days 1-28. >

>

>

>

>

> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

>

>

>

>

>

> placebo: Given PO

Overall Number of Participants Analyzed 16 17
Median (95% Confidence Interval)
Unit of Measure: Months
4.86
(3.0 to 6.43)
3.29
(2.43 to 10.43)
2.Secondary Outcome
Title Overall Adverse Event Rates for Grade 2 or Higher Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0
Hide Description Frequency tables will be reviewed to determine adverse event patterns, this data is reported in the adverse events section of this report. Below is the number of patients that experienced an adverse event greater than or equal to 2.
Time Frame up to 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable patients
Arm/Group Title Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SBI PO BID on days 1-28. >>

>> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

>>

>> serum-derived bovine immunoglobulin protein isolate: Given PO

Patients receive placebo PO BID on days 1-28. >>

>> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

>>

>> placebo: Given PO

Overall Number of Participants Analyzed 16 17
Measure Type: Count of Participants
Unit of Measure: Participants
5
  31.3%
10
  58.8%
3.Secondary Outcome
Title Surgical Complication Rates
Hide Description Compared between the 2 arms using Chi-Square or Fisher's Exact tests.
Time Frame Up to 1 month post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable patients
Arm/Group Title Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive SBI PO BID on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients receive placebo PO BID on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 16 17
Measure Type: Count of Participants
Unit of Measure: Participants
Severe Complication
3
  18.8%
3
  17.6%
Moderate Complication
2
  12.5%
7
  41.2%
Mild Complication
10
  62.5%
6
  35.3%
No Complication
1
   6.3%
1
   5.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Intervention Compliance Assessed Using the Compliance Questionnaire
Hide Description The frequency and percentage for each Compliance Questionnaire category will be summarized descriptively by cycle and by intervention arm. In addition, cycle by cycle compliance data will be compared between the 2 arms using a Chi-square test.
Time Frame up to 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive SBI PO BID on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. serum-derived bovine immunoglobulin protein isolate: Given PO
Patients receive placebo PO BID on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.placebo: Given PO
Overall Number of Participants Analyzed 16 17
Measure Type: Count of Participants
Unit of Measure: Participants
Cycle 1 Always to Usually Compliant
8
  50.0%
13
  76.5%
Occasionally to Never Compliant
5
  31.3%
4
  23.5%
Missing
3
  18.8%
0
   0.0%
Patient off treatment (NA)
0
   0.0%
0
   0.0%
Cycle 2 Always to Usually Compliant
3
  18.8%
7
  41.2%
Occasionally to Never Compliant
1
   6.3%
0
   0.0%
Missing
0
   0.0%
1
   5.9%
Patient off treatment (NA)
12
  75.0%
9
  52.9%
5.Secondary Outcome
Title Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale
Hide Description All 14 of the individual items from the PQL tool, along with the 4 additional items after the PQL questions will be analyzed and compared between the 2 intervention arms. Differences between post-randomization and baseline QOL scores will be analyzed and compared between the 2 arms using a Wilcoxon Rank-sum test. Also, other graphical and statistical methods will be used to compare the QOL between the 2 arms over time. For this endpoint, the total QOL score could range from 1 to 140 (0 being the worst and 140 being the best). These scores will be converted to the percentage scale, where a score of 140 will be converted to 100 and a score of 0 will remain as 0. This QOL will be measured weekly for the entire 12 week length of the study and at the end of the intervention. QOL improvement will be defined as at least a 10 point increase in the QOL score from baseline, on the percentage scale.
Time Frame up to 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable patients
Arm/Group Title Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive SBI PO BID on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients receive placebo PO BID on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 16 17
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement
11
  68.8%
13
  76.5%
No Improvement
5
  31.3%
4
  23.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Change in QOL in Patients Who do Not Start Intervention or Discontinue Early, Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale
Hide Description Analysis will be descriptive in nature to see if these patients have a poorer QOL than patients who stay on study.
Time Frame Baseline up to 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable patients who never started intervention or discontinue early. All patients completed the study, no patients are evaluable for this outcome.
Arm/Group Title Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive SBI PO BID on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients receive placebo PO BID on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 25 months
Adverse Event Reporting Description The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for AE reporting. Participants who did NOT withdraw ("Withdrawal by Subject") from the study are included in this analysis.
 
Arm/Group Title Arm II (Placebo) Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate)
Hide Arm/Group Description questionnaire administration: Ancillary studies questionnaire administration: Ancillary studies
All-Cause Mortality
Arm II (Placebo) Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/18 (0.00%)    
Hide Serious Adverse Events
Arm II (Placebo) Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/16 (18.75%)      3/18 (16.67%)    
Blood and lymphatic system disorders     
Anemia  1  0/16 (0.00%)  0 1/18 (5.56%)  1
Gastrointestinal disorders     
Abdominal pain  1  2/16 (12.50%)  2 1/18 (5.56%)  1
Ileus  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Nausea  1  2/16 (12.50%)  2 1/18 (5.56%)  1
Small intestinal obstruction  1  3/16 (18.75%)  3 1/18 (5.56%)  1
Vomiting  1  2/16 (12.50%)  2 0/18 (0.00%)  0
General disorders     
Fatigue  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Infections and infestations     
Urinary tract infection  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Investigations     
Platelet count decreased  1  0/16 (0.00%)  0 1/18 (5.56%)  1
Metabolism and nutrition disorders     
Dehydration  1  0/16 (0.00%)  0 1/18 (5.56%)  1
Hyponatremia  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Vascular disorders     
Thromboembolic event  1  1/16 (6.25%)  1 0/18 (0.00%)  0
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm II (Placebo) Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/16 (93.75%)      15/18 (83.33%)    
Gastrointestinal disorders     
Abdominal pain  1  9/16 (56.25%)  12 7/18 (38.89%)  16
Bloating  1  8/16 (50.00%)  12 4/18 (22.22%)  7
Diarrhea  1  4/16 (25.00%)  6 4/18 (22.22%)  6
Flatulence  1  6/16 (37.50%)  7 9/18 (50.00%)  21
Nausea  1  7/16 (43.75%)  8 8/18 (44.44%)  12
Vomiting  1  4/16 (25.00%)  4 5/18 (27.78%)  5
General disorders     
Fatigue  1  12/16 (75.00%)  20 14/18 (77.78%)  31
Infections and infestations     
Wound infection  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Injury, poisoning and procedural complications     
Wound complication  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Wound dehiscence  1  0/16 (0.00%)  0 1/18 (5.56%)  1
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Aminah Jatoi, M.D.
Organization: Mayo Clinic
Phone: (507) 284-4918
EMail: jatoi.aminah@mayo.edu
Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01867606    
Other Study ID Numbers: MC1267
NCI-2013-00866 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1267 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Submitted: May 29, 2013
First Posted: June 4, 2013
Results First Submitted: August 28, 2018
Results First Posted: April 1, 2020
Last Update Posted: October 23, 2020