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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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