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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

Tracking Information
First Submitted Date  ICMJE May 29, 2013
First Posted Date  ICMJE June 4, 2013
Results First Submitted Date  ICMJE August 28, 2018
Results First Posted Date  ICMJE April 1, 2020
Last Update Posted Date October 23, 2020
Actual Study Start Date  ICMJE October 4, 2013
Actual Primary Completion Date November 21, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
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 [ Time Frame: up to 25 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2013)
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 [ Time Frame: Baseline to 12 weeks ]
The total 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
  • Overall Adverse Event Rates for Grade 2 or Higher Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: up to 25 months ]
    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.
  • Surgical Complication Rates [ Time Frame: Up to 1 month post-surgery ]
    Compared between the 2 arms using Chi-Square or Fisher's Exact tests.
  • Intervention Compliance Assessed Using the Compliance Questionnaire [ Time Frame: up to 25 months ]
    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.
  • Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale [ Time Frame: up to 25 months ]
    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.
  • 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 [ Time Frame: Baseline up to 25 months ]
    Analysis will be descriptive in nature to see if these patients have a poorer QOL than patients who stay on study.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2013)
  • Overall adverse event rates for grade 2 or higher adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Up to 16 weeks ]
    Frequency tables will be reviewed to determine adverse event patterns. Compared using Chi-square or Fisher's exact tests.
  • Surgical Complication Rates [ Time Frame: Up to 1 month post-surgery ]
    Compared between the 2 arms using Chi-Square or Fisher's Exact tests.
  • Intervention Compliance Assessed Using the Compliance Questionnaire [ Time Frame: Up to 16 weeks ]
    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.
  • Change in QOL measured using the 14-item PQL tool, Uniscale, and the previously-validated Symptom Distress Scale (SDS) [ Time Frame: Baseline up to 12 weeks ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
Official Title  ICMJE MC1267, A Randomized, Blinded Pilot Placebo-Controlled Trial With Oral Serum Bovine Immunoglobulin (SBI) to Assess Quality of Life and the Faster Post-Operative Recovery of Gynecological Cancer Patients
Brief Summary This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein isolate works in improving quality of life and post-operative recovery in patients with cancer of the female reproductive tract after undergoing surgery. Serum bovine immunoglobulin may help provide nutrition to patients who are not able to eat or digest ordinary food. This may improve the quality of life of patients with gynecological cancer and help them recover more quickly from surgery.
Detailed Description

PRIMARY OBJECTIVES:

I. To compare the time-to-quality of life (QOL) improvement from baseline in postoperative gynecological cancer patients who are receiving oral serum bovine immunoglobulin (SBI) vs. placebo.

SECONDARY OBJECTIVES:

I. To compare the surgical complication rates between oral SBI vs. placebo up to 1 month post-surgery (safety endpoint).

II. To compare the QOL, as derived from the previously-validated Symptom Distress Scale, the Postoperative Quality of Life questionnaire (PQL), and the uniscale (overall QOL item) between patients receiving oral SBI vs. placebo.

III. To compare the grade 2 or worse adverse event rates for patients receiving oral SBI vs. placebo.

IV. To characterize the adverse event profile of oral SBI in postoperative gynecological cancer patients (safety endpoint).

V. To compare supplement adherence between patients receiving oral SBI vs. placebo.

TERTIARY OBJECTIVES:

I. To explore whether candidate biomarkers are modified with SBI versus placebo.

II. As part of ongoing research, to bank leftover blood samples for future studies.

III. To explore quality of life during postoperative recovery after gynecologic surgery, regardless of whether or not patients take the study intervention/placebo or discontinue intervention/placebo early.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive SBI orally (PO) twice daily (BID) on days 1-28.

ARM II: Patients receive placebo PO BID on days 1-28.

In both arms, treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Female Reproductive Cancer
Intervention  ICMJE
  • Biological: serum-derived bovine immunoglobulin protein isolate
    Given PO
    Other Names:
    • SBI
    • serum bovine immunoglobulin
  • Other: placebo
    Given PO
    Other Name: PLCB
  • Other: laboratory biomarker analysis
    Correlative studies
  • Other: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
  • Other: questionnaire administration
    Ancillary studies
Study Arms  ICMJE
  • Experimental: Arm I (serum-derived bovine immunoglobulin protein isolate)

    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.

    Interventions:
    • Biological: serum-derived bovine immunoglobulin protein isolate
    • Other: laboratory biomarker analysis
    • Other: quality-of-life assessment
    • Other: questionnaire administration
  • Placebo Comparator: Arm II (placebo)

    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.

    Interventions:
    • Other: placebo
    • Other: laboratory biomarker analysis
    • Other: quality-of-life assessment
    • Other: questionnaire administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 30, 2020)
58
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2013)
74
Estimated Study Completion Date  ICMJE October 15, 2021
Actual Primary Completion Date November 21, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of gynecological cancer of any type or strong suspicion for cancer
  • Patients must have begun postoperative oral intake of food prior to registration
  • Open laparotomy or laparoscopic surgery undertaken with cancer therapeutic intent (not a subsequent surgery to manage a postoperative complication) that had occurred =< 7 days prior to registration and that entailed more than a simple hysterectomy
  • Creatinine =< 1.5 x the upper limit of normal (ULN)
  • Absolute neutrophil count >= 1500/mm^3
  • Platelet count >= 100,000/mm^3
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Provide informed written consent
  • Negative (serum) pregnancy test done =< 7 days prior to randomization, for women of childbearing potential only
  • Willing to provide mandatory baseline blood samples for correlative research purposes

Exclusion Criteria:

  • Symptomatic and/or untreated brain metastases
  • Ongoing parenteral nutrition (receiving intravenous nutrition support at the time of enrollment); note: patients may be receiving maintenance intravenous (IV) fluids
  • Current enrollment in any other trial that entails the concurrent administration of any other agent designed to enhance postoperative recovery
  • Allergy to beef
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01867606
Other Study ID Numbers  ICMJE MC1267
NCI-2013-00866 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1267 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Aminah Jatoi Mayo Clinic
PRS Account Mayo Clinic
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP