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MC1267, A Randomized, Blinded Phase II Placebo-Controlled Trial With Oral Serum Bovine Immunoglobulin (SBI) to Assess Quality of Life and the Faster Post-Operative Recovery of Gynecological Cancer Patients


Phase 2
18 Years
N/A
Not Enrolling
Female
Female Reproductive Cancer

Thank you

Trial Information

MC1267, A Randomized, Blinded Phase II Placebo-Controlled Trial With Oral Serum Bovine Immunoglobulin (SBI) to Assess Quality of Life and the Faster Post-Operative Recovery of Gynecological Cancer Patients


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.

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

- Patients must have begun postoperative oral intake of food prior to registration

- An open laparotomy, cancer therapeutic surgery (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)

- Total bilirubin =< 1.5 x ULN

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2 x
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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome 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

Outcome Description:

The total 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.

Outcome Time Frame:

Baseline to 12 weeks

Safety Issue:

No

Principal Investigator

Aminah Jatoi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

MC1267

NCT ID:

NCT01867606

Start Date:

July 2013

Completion Date:

Related Keywords:

  • Female Reproductive Cancer

Name

Location

Mayo ClinicRochester, Minnesota  55905