Female Reproductive CancerPhase 2NCT01867606
Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
A Phase 2 study testing serum-derived bovine immunoglobulin protein isolate, laboratory biomarker analysis and quality-of-life assessment in people with Female Reproductive Cancer, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Reproductive Cancer
- What is being tested?
- serum-derived bovine immunoglobulin protein isolate, laboratory biomarker analysis and quality-of-life assessment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2013to 21 Nov 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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).
- To compare supplement adherence between patients receiving oral SBI vs. placebo.
TERTIARY OBJECTIVES:
- 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.
- Conditions
- Female Reproductive Cancer
- Being tested
- serum-derived bovine immunoglobulin protein isolate, placebo, laboratory biomarker analysis, quality-of-life assessment, questionnaire administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum-derived bovine immunoglobulin protein isolateBiological
Also called SBI, serum bovine immunoglobulin
Given PO
placeboOther
Also called PLCB
Given PO
laboratory biomarker analysisOther
Correlative studies
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (serum-derived bovine immunoglobulin protein isolate) | 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. Receives: Biological: serum-derived bovine immunoglobulin protein isolate; Other: laboratory biomarker analysis; Other: quality-of-life assessment; Other: questionnaire administration |
| Arm II (placebo) | 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. Receives: Other: placebo; Other: laboratory biomarker analysis; Other: quality-of-life assessment; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
For this endpoint, the total QOL 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.the total score of the 14-item Postoperative Quality of Life (PQL) tool [15] will be used, where the total score could range from 0 to 140 (0 being the worst and 140 being the best). These scores will be converted to the percentage scale, where a score of 140 will be converted to 100 and a score of 0 will remain as 0. This QOL will be measured weekly for the entire 12 week length of the study and at the end of the intervention. QOL improvement will be defined as at least a 10 point increase in the QOL score from baseline, on the percentage scale.
Measured: up to 25 months
Secondary outcomes (5)
Overall Adverse Event Rates for Grade 2 or Higher Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0
Frequency tables will be reviewed to determine adverse event patterns, this data is reported in the adverse events section of this report. Below is the number of patients that experienced an adverse event greater than or equal to 2.
Measured: up to 25 months
Surgical Complication Rates
Compared between the 2 arms using Chi-Square or Fisher's Exact tests.
Measured: Up to 1 month post-surgery
Intervention Compliance Assessed Using the Compliance Questionnaire
The frequency and percentage for each Compliance Questionnaire category will be summarized descriptively by cycle and by intervention arm. In addition, cycle by cycle compliance data will be compared between the 2 arms using a Chi-square test.
Measured: up to 25 months
Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale
All 14 of the individual items from the PQL tool, along with the 4 additional items after the PQL questions will be analyzed and compared between the 2 intervention arms. Differences between post-randomization and baseline QOL scores will be analyzed and compared between the 2 arms using a Wilcoxon Rank-sum test. Also, other graphical and statistical methods will be used to compare the QOL between the 2 arms over time. For this endpoint, the total QOL score could range from 1 to 140 (0 being the worst and 140 being the best). These scores will be converted to the percentage scale, where a score of 140 will be converted to 100 and a score of 0 will remain as 0. This QOL will be measured weekly for the entire 12 week length of the study and at the end of the intervention. QOL improvement will be defined as at least a 10 point increase in the QOL score from baseline, on the percentage scale.
Measured: up to 25 months
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
Analysis will be descriptive in nature to see if these patients have a poorer QOL than patients who stay on study.
Measured: Baseline up to 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study start4 Oct 2013
- Primary completion21 Nov 2015
- Study completion21 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Female Reproductive CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aminah Jatoi, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867606
- Sponsor's protocol ID
- MC1267
- Other IDs
- NCI-2013-00866, MC1267, 12-009448
- Status last verified
- Mar 2025
- First submitted
- 29 May 2013
- Last updated
- 1 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01867606
- Acronym / sponsor ID
- MC1267
- Conditions
- Female Reproductive Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 4 Oct 2013 (actual)
- Primary completion
- 21 Nov 2015 (actual)
- Study completion
- 21 Nov 2015 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Posted 1 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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).
- To compare supplement adherence between patients receiving oral SBI vs. placebo.
TERTIARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (serum-derived bovine immunoglobulin protein isolate) | Experimental | Biological: serum-derived bovine immunoglobulin protein isolate, Other: laboratory biomarker analysis, Other: quality-of-life assessment, Other: questionnaire administrationPatients 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. |
| Arm II (placebo) | Placebo comparator | Other: placebo, Other: laboratory biomarker analysis, Other: quality-of-life assessment, Other: questionnaire administrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum-derived bovine immunoglobulin protein isolateAlso: SBI, serum bovine immunoglobulinGiven PO | Biological | Arm I (serum-derived bovine immunoglobulin protein isolate) |
| placeboAlso: PLCBGiven PO | Other | Arm II (placebo) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (serum-derived bovine immunoglobulin protein isolate), Arm II (placebo) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Other | Arm I (serum-derived bovine immunoglobulin protein isolate), Arm II (placebo) |
| questionnaire administrationAncillary studies | Other | Arm I (serum-derived bovine immunoglobulin protein isolate), Arm II (placebo) |
Primary outcome
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: up to 25 months
For this endpoint, the total QOL 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.the total score of the 14-item Postoperative Quality of Life (PQL) tool [15] will be used, where the total score could range from 0 to 140 (0 being the worst and 140 being the best). These scores will be converted to the percentage scale, where a score of 140 will be converted to 100 and a score of 0 will remain as 0. This QOL will be measured weekly for the entire 12 week length of the study and at the end of the intervention. QOL improvement will be defined as at least a 10 point increase in the QOL score from baseline, on the percentage scale.
5 secondary outcomes
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 25 months
Surgical Complication Rates
Time frame: Up to 1 month post-surgery
Intervention Compliance Assessed Using the Compliance Questionnaire
Time frame: up to 25 months
Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale
Time frame: up to 25 months
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 25 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Female Reproductive Cancer
RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
RecruitingObservational study
Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study
Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm
Active, not recruitingPhase 2
Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer
Ovarian Clear Cell Carcinoma, Gynecologic Cancer
Active, not recruiting
e-Health Intervention (Day-by-Day) for the Management of Fear of Progression in Women With Stage III or IV Gynecologic Cancer: A Pilot Study
Malignant Female Reproductive System Neoplasm, Stage III Cervical Cancer AJCC v8
Recruiting
PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy
Gynecologic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aminah Jatoi, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing serum-derived bovine immunoglobulin protein isolate, laboratory biomarker analysis and quality-of-life assessment in people with Female Reproductive Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: up to 25 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.