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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 : Unknown
Verified August 2016 by Mayo Clinic.
Recruitment status was:  Active, not recruiting
First Posted : June 4, 2013
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Female Reproductive Cancer Biological: serum-derived bovine immunoglobulin protein isolate Other: placebo Other: laboratory biomarker analysis Other: quality-of-life assessment Other: questionnaire administration Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : October 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Biological: serum-derived bovine immunoglobulin protein isolate
Given PO
Other Names:
  • SBI
  • serum bovine immunoglobulin

Other: laboratory biomarker analysis
Correlative studies

Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Other: questionnaire administration
Ancillary studies

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.

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




Primary Outcome Measures :
  1. 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 up to 16 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.


Secondary Outcome Measures :
  1. 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 16 weeks ]
    Frequency tables will be reviewed to determine adverse event patterns. Compared using Chi-square or Fisher's exact tests.

  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.

  3. 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.

  4. Change in QOL measured using the 14-item PQL tool, Uniscale, and the previously-validated Symptom Distress Scale [ Time Frame: Baseline up to 16 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.

  5. 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 16 weeks ]
    Analysis will be descriptive in nature to see if these patients have a poorer QOL than patients who stay on study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867606


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Aminah Jatoi Mayo Clinic

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01867606     History of Changes
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 Posted: June 4, 2013    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2016

Additional relevant MeSH terms:
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs