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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 25 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 25 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 25 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreSide effects data
From 2008 Phase 3 trial • 186 Patients • NCT0000386961%
Nausea
59%
Neuro-Sensory
53%
Fatigue
49%
Anemia
32%
Vomiting
32%
Ataxia
31%
Anorexia
17%
Dyspnea
16%
Constipation
13%
Alopecia
12%
Thrombocytopenia
9%
Neutropenia
9%
Creatinine
9%
Dizziness
8%
Cough
8%
Arthralgia
7%
Vision-Blurred
6%
Depression
6%
Pain
4%
Headache
4%
Diarrhea-No Colostom
4%
Edema
4%
Infection without neutropenia
4%
Hyperglycemia
4%
Neuro-Motor
3%
Rash
3%
SGOT (AST) (serum glutamic oxaloacetic transaminase)
3%
Pain-Abdominal
3%
Pain-Chest
3%
Lymphopenia
3%
Myalgia
3%
Taste
3%
Weight loss
2%
Hemoptysis
2%
Muscle Weakness
2%
Dyspepsia
2%
Hyponatremia
2%
SGPT (ALT) (serum glutamic pyruvic transaminase)
2%
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
2%
Bilirubin
2%
Leukopenia
2%
Pain-Bone
2%
Low Consciousness
2%
Memory Loss
2%
Neuralgia
2%
Inner Ear
2%
Anxiety
2%
Confusion
1%
Epistaxis
1%
Dysphagia
1%
Hypotension
1%
Fever-No ANC
1%
Insomnia
1%
Hypertension
1%
Mouth Dryness
1%
Pulmonary
1%
Pruritis
1%
Flatulence
1%
Stomatitis
1%
Hypoalbuminemia
1%
Vision
1%
Hypoxia
1%
Smell
1%
Arrythmia
1%
Sweating
1%
Voice Change
1%
Hematemesis
1%
Prothrombin Time
1%
Adult respiratory distress syndrome (ARDS)
1%
Effusion-Pleural
1%
Pneumonitis
1%
Arrhythmia-Nodal
1%
Cardiovascular
1%
Palpitations
1%
Vision-Double
1%
Rigors
1%
Hypokalemia
1%
Musculoskeletal
1%
Learning Disorder
1%
Tremor
1%
Diarrhea-BMT
1%
Allergy
1%
Dehydration
1%
Thrombosis
100%
80%
60%
40%
20%
0%
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.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,082 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,431 Total Patients Enrolled
Aminah Jatoi, M.D.Principal InvestigatorMayo Clinic
9 Previous Clinical Trials
341 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases that are causing symptoms or have not been treated.I am currently receiving nutrition through an IV.I had major cancer surgery (not just a simple hysterectomy) within the last 7 days.I have or am suspected to have gynecological cancer.I have started eating by mouth after my surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (serum-derived bovine immunoglobulin protein isolate)
- Group 2: Arm II (placebo)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared quality-of-life assessment for therapeutic use?
"There is some evidence to support quality-of-life assessment's safety, but none for efficacy. Therefore, it was given a score of 2."
Answered by AI
Are new participants still being sought for this trial?
"According to the latest information available on clinicaltrials.gov, this study is no longer recruiting patients. The trial was first posted on October 4th 2013 and updated February 3rd 2022. There are two other trials open for recruitment at this time."
Answered by AI
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