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

Overview

About this study

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 gynecological cancer after undergoing surgery. Serum bovine immunoglobulin supplementation may improve the quality of life of patients with gynecological cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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
  • Had an open laparotomy, laparoscopic surgery, or cancer therapeutic surgery (not a subsequent surgery to manage a postoperative complication) that 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Aminah Jatoi, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20112310

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