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Bovine Immunoglobulin for Cervical Cancer

Phase 2

Waitlist Available

Led By Aminah Jatoi, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of gynecological cancer of any type or strong suspicion for cancer

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

Must not have

Symptomatic and/or untreated brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 25 months

Summary

This trial is testing how well a serum made from cow immunoglobulin proteins may improve quality of life and post-operative recovery for patients with cancer of the female reproductive tract.

Who is the study for?

This trial is for women who have had recent surgery for gynecological cancer and are able to eat orally. They must not be pregnant, should have a stable blood count, and no severe kidney issues. Participants need to be able to fill out questionnaires and provide blood samples for research.

What is being tested?

The study tests if serum bovine immunoglobulin protein isolate can improve recovery and quality of life after surgery in patients with gynecological cancer compared to a placebo. It involves taking the supplement, monitoring through biomarkers, assessing quality of life, and completing questionnaires.

What are the potential side effects?

Potential side effects may include allergic reactions in those sensitive to beef products since the treatment is derived from bovine (cow) serum proteins.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have or am suspected to have gynecological cancer.

Select...

I have started eating by mouth after my surgery.

Select...

I had major cancer surgery (not just a simple hysterectomy) within the last 7 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have brain metastases that are causing symptoms or have not been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 25 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 25 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 25 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale

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

Intervention Compliance Assessed Using the Compliance Questionnaire

+2 more

Side effects data

From 2008 Phase 3 trial • 186 Patients • NCT00003869

61%

Nausea

59%

Neuro-Sensory

53%

Fatigue

49%

Anemia

32%

Vomiting

32%

Ataxia

31%

Anorexia

17%

Dyspnea

16%

Constipation

13%

Alopecia

12%

Thrombocytopenia

Neutropenia

Creatinine

Dizziness

Arthralgia

Cough

Vision-Blurred

Depression

Pain

Diarrhea-No Colostom

Headache

Edema

Infection without neutropenia

Hyperglycemia

Neuro-Motor

Rash

SGOT (AST) (serum glutamic oxaloacetic transaminase)

Pain-Abdominal

Pain-Chest

Lymphopenia

Myalgia

Taste

Weight loss

Dyspepsia

Hyponatremia

Hemoptysis

SGPT (ALT) (serum glutamic pyruvic transaminase)

Muscle Weakness

Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)

Bilirubin

Leukopenia

Pain-Bone

Low Consciousness

Memory Loss

Neuralgia

Inner Ear

Anxiety

Confusion

Hypertension

Pruritis

Hypoxia

Stomatitis

Dysphagia

Hypoalbuminemia

Insomnia

Voice Change

Vision

Hypotension

Mouth Dryness

Smell

Arrythmia

Sweating

Epistaxis

Flatulence

Fever-No ANC

Pulmonary

Hematemesis

Prothrombin Time

Adult respiratory distress syndrome (ARDS)

Effusion-Pleural

Pneumonitis

Arrhythmia-Nodal

Cardiovascular

Palpitations

Vision-Double

Rigors

Hypokalemia

Musculoskeletal

Learning Disorder

Tremor

Diarrhea-BMT

Allergy

Dehydration

Thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Carboxyamidotriazole

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (serum-derived bovine immunoglobulin protein isolate)Experimental Treatment4 Interventions

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.

Group II: Arm II (placebo)Placebo Group4 Interventions

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.

0 / 4Eligibility criteria met