Phase 2
Completed N=58
Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
Female Reproductive Cancer
Source: ClinicalTrials.gov NCT01867606 ↗
Enrolled (actual)
58
Serious AEs
17.7%
Results posted
Apr 2020
Primary outcomePrimary: 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 — 4.86; 3.29 Months
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
4.86; 3.29 | — |
| SECONDARY Overall Adverse Event Rates for Grade 2 or Higher Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0 |
5; 10 | — |
| SECONDARY Surgical Complication Rates |
3; 3; 2; 7; 10; 6 | 0.29 |
| SECONDARY Intervention Compliance Assessed Using the Compliance Questionnaire |
8; 13; 5; 4; 3; 0 | — |
| SECONDARY Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale |
11; 13; 5; 4 | 0.62 |
| SECONDARY 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 |
— | — |
Eligibility 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 = = 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
Data sourced from ClinicalTrials.gov (NCT01867606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.