Clinical trial NCT01867606: Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Female Reproductive Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 =\< 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

Primary outcomes:
measure: 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
timeFrame: up to 25 months
Secondary outcomes:
measure: Overall Adverse Event Rates for Grade 2 or Higher Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0
timeFrame: up to 25 months
measure: Surgical Complication Rates
timeFrame: Up to 1 month post-surgery
measure: Intervention Compliance Assessed Using the Compliance Questionnaire
timeFrame: up to 25 months
measure: Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale
timeFrame: up to 25 months
measure: 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
timeFrame: Baseline up to 25 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Aminah Jatoi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: