Overview

This trial is active, not recruiting.

Condition female reproductive cancer
Treatments serum-derived bovine immunoglobulin protein isolate, placebo, laboratory biomarker analysis, quality-of-life assessment, questionnaire administration
Phase phase 2
Sponsor Mayo Clinic
Collaborator National Cancer Institute (NCI)
Start date October 2013
End date July 2018
Trial size 100 participants
Trial identifier NCT01867606, MC1267, NCI-2013-00866, P30CA015083

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Experimental)
Patients receive SBI PO BID on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
serum-derived bovine immunoglobulin protein isolate SBI
Given PO
laboratory biomarker analysis
Correlative studies
quality-of-life assessment quality of life assessment
Ancillary studies
questionnaire administration
Ancillary studies
(Placebo Comparator)
Patients receive placebo PO BID on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
placebo PLCB
Given PO
laboratory biomarker analysis
Correlative studies
quality-of-life assessment quality of life assessment
Ancillary studies
questionnaire administration
Ancillary studies

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
time frame: Baseline to up to 16 weeks

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
time frame: Up to 16 weeks
Surgical complication rates
time frame: Up to 1 month post-surgery
Intervention compliance assessed using the Compliance Questionnaire
time frame: Up to 16 weeks
Change in QOL measured using the 14-item PQL tool, Uniscale, and the previously-validated Symptom Distress Scale
time frame: Baseline up to 16 weeks
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
time frame: Baseline up to 16 weeks

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
Principal investigator Aminah Jatoi
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.
Location data was received from the National Cancer Institute and was last updated in October 2016.