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

NCT01867606 | Completed Phase 2 Results

• 3 other identifiers: MC1267NCI-2013-0086612-009448
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Reproductive Cancer

Outcome Measures

Primary Outcomes (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

  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.

  up to 25 months

Secondary Outcomes (5)

• Overall Adverse Event Rates for Grade 2 or Higher Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0

  up to 25 months

• Surgical Complication Rates

  Up to 1 month post-surgery

• Intervention Compliance Assessed Using the Compliance Questionnaire

  up to 25 months

• Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale

  up to 25 months

• 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

  Baseline up to 25 months

Study Arms (2)

Arm I (serum-derived bovine immunoglobulin protein isolate)

EXPERIMENTAL

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; Other: laboratory biomarker analysis; Other: quality-of-life assessment; Other: questionnaire administration

Arm II (placebo)

PLACEBO COMPARATOR

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; Other: laboratory biomarker analysis; Other: quality-of-life assessment; Other: questionnaire administration

Interventions

serum-derived bovine immunoglobulin protein isolate BIOLOGICAL

Given PO

Also known as: SBI, serum bovine immunoglobulin

Arm I (serum-derived bovine immunoglobulin protein isolate)

placebo OTHER

Given PO

Also known as: PLCB

Arm II (placebo)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (serum-derived bovine immunoglobulin protein isolate); Arm II (placebo)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Arm I (serum-derived bovine immunoglobulin protein isolate); Arm II (placebo)

questionnaire administration OTHER

Ancillary studies

Arm I (serum-derived bovine immunoglobulin protein isolate); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Aminah Jatoi, M.D.
• Organization: Mayo Clinic

jatoi.aminah@mayo.edu

(507) 284-4918

Study Officials

• Aminah Jatoi, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 4, 2013
• Study Start: October 4, 2013
• Primary Completion: November 21, 2015
• Study Completion: November 21, 2015
• Last Updated: April 1, 2025
• Results First Posted: April 1, 2020

Record last verified: 2025-03

Locations

US (1)