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



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:8/30/2017
Start Date:October 2013
End Date:July 2018

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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

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.

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.

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
We found this trial at
1
site
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
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