MucositisPhase 2NCT04239261
Serum-derived Bovine Immunoglobulin Effect on Mucositis
A Phase 2 study testing SBI in people with Mucositis, run by MercyOne Des Moines Medical Center at 1 site in United States.
Trial summary
The purpose of this cancer control clinical research study is to evaluate whether nutritional therapy with Serum-derived bovine immunoglobulin/protein isolate (SBI) might reduce mucositis (a condition caused by cancer treatment involving mouth sores, pain and/or bleeding that may cause difficulty eating), improve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucositis
- What is being tested?
- SBI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2020to 24 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained and signed
- Male or female at least 18 years of age
- Diagnosed with head, neck, or lung cancer and scheduled to undergo combined chemo-radiation therapy
- Diagnosed with head, neck, or lung cancer with disease stage within the criteria described in 4.0 Staging Criteria
- Not experiencing diarrhea during the 5 days preceding enrollment, as defined by having less than two unformed bowel movements per day or loose (mushy) or watery stools in the 5 days preceding enrollment.
- Not currently taking anti-diarrheal medications (prescription or over the counter).
- Agrees and is able to take the investigational products or placebo starting from the day of enrollment (approximately 7-14 days prior to beginning chemo-radiation therapy) through 6-7 weeks of chemo-radiation therapy (for a total of 8-9 weeks).
Who cannot join
- History of uncontrolled diarrhea during screening.
- History of Irritable Bowel Syndrome with Diarrhea with a normal pattern of more than three bowel movements in a 24 hour period.
- History of inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis.
- History of active infectious diarrhea and receiving therapy within 10 days of the first dose of study drug or placebo.
- Known allergy or intolerance to beef or soy or any ingredient used in the product
- History of concurrent intensive chemotherapy within 10 days of the first scheduled dose of study drug or placebo.
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- Gastrointestinal surgery or bowel resection that could affect study product absorption (this does not include cholecystectomy or appendectomy).
- Unable to comply with the protocol requirements.
- Any condition that in the opinion of the Investigator might interfere with the study objective.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
MercyOne Des Moines Medical Center
Des Moines, Iowa, 50314
About this study
Official title: A Randomized, Placebo-Controlled, Pilot Study of Serum-Derived Bovine Immunoglobulin/Protein Isolate to Manage Mucositis in Patients Undergoing Treatment for Head, Neck, or Lung Cancer
The purpose of this cancer control clinical research study is to evaluate whether nutritional therapy with Serum-derived bovine immunoglobulin/protein isolate (SBI) might reduce mucositis (a condition caused by cancer treatment involving mouth sores, pain and/or bleeding that may cause difficulty eating), improve nutritional status and lessen the symptoms associated with chemo-radiation therapy which may result in quality of life (QOL) improvements during the prescribed treatment for cancer therapy.
- Conditions
- Mucositis
- Being tested
- SBI, Placebo
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBIDietary supplement
Serum-derived Bovine immunoglobulin/protein isolate 10.0 g once daily
PlaceboDietary supplement
Hydrolyzed gelatin 10.0 g once daily
| Study group | Role | What they receive |
|---|---|---|
| Nutritional therapy | Active comparator | Serum-derived bovine immunoglobulin/protein isolate (SBI) 10.0 grams once daily Receives: Dietary Supplement: SBI |
| Placebo | Placebo comparator | Hydrolyzed gelatin 10.0 grams once daily Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Oral Mucositis during ChemoRadiation Treatment
CTCAE version 5 will be used to determine adverse event grade of mucositis, if applicable
Measured: Baseline and Up to approximately 90 days after randomization
Secondary outcomes (2)
Development of Dysphagia during ChemoRadiation Treatment
CTCAE version 5 will be used to determine advent grade of dysphagia, if applicable
Measured: Baseline and Up to approximately 90 days after randomization
Change in Bowel Movements
Stool Diary Card will be completed by patient to document consistency, ease and completeness
Measured: Baseline and Up to approximately 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start17 Jan 2020
- Primary completion24 Jan 2023
- Study completion24 Jan 2023
Why it stopped: Recruitment slower than anticipated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- MercyOne Des Moines Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Deming, MD, MercyOne Des Moines Medical Center
- Investigators
- Richard Deming, MD, Principal investigator, MercyOne Des Moines Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239261
- Sponsor's protocol ID
- HNL-MUCO
- Status last verified
- Jan 2023
- First submitted
- 14 Jan 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Pilot Study of Serum-Derived Bovine Immunoglobulin/Protein Isolate to Manage Mucositis in Patients Undergoing Treatment for Head, Neck, or Lung Cancer
- ClinicalTrials.gov ID
- NCT04239261
- Acronym / sponsor ID
- HNL-MUCO
- Conditions
- Mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment slower than anticipated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- MercyOne Des Moines Medical CenterUniversity, hospital or other
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this cancer control clinical research study is to evaluate whether nutritional therapy with Serum-derived bovine immunoglobulin/protein isolate (SBI) might reduce mucositis (a condition caused by cancer treatment involving mouth sores, pain and/or bleeding that may cause difficulty eating), improve nutritional status and lessen the symptoms associated with chemo-radiation therapy which may result in quality of life (QOL) improvements during the prescribed treatment for cancer therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional therapy | Active comparator | Dietary Supplement: SBISerum-derived bovine immunoglobulin/protein isolate (SBI) 10.0 grams once daily |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboHydrolyzed gelatin 10.0 grams once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent obtained and signed
- Male or female at least 18 years of age
- Diagnosed with head, neck, or lung cancer and scheduled to undergo combined chemo-radiation therapy
- Diagnosed with head, neck, or lung cancer with disease stage within the criteria described in 4.0 Staging Criteria
- Not experiencing diarrhea during the 5 days preceding enrollment, as defined by having less than two unformed bowel movements per day or loose (mushy) or watery stools in the 5 days preceding enrollment.
Key exclusion criteria (10 listed)
- History of uncontrolled diarrhea during screening.
- History of Irritable Bowel Syndrome with Diarrhea with a normal pattern of more than three bowel movements in a 24 hour period.
- History of inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis.
- History of active infectious diarrhea and receiving therapy within 10 days of the first dose of study drug or placebo.
- Known allergy or intolerance to beef or soy or any ingredient used in the product
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 |
|---|---|---|
| SBISerum-derived Bovine immunoglobulin/protein isolate 10.0 g once daily | Dietary supplement | Nutritional therapy |
| PlaceboHydrolyzed gelatin 10.0 g once daily | Dietary supplement | Placebo |
Primary outcome
Development of Oral Mucositis during ChemoRadiation Treatment
Time frame: Baseline and Up to approximately 90 days after randomization
CTCAE version 5 will be used to determine adverse event grade of mucositis, if applicable
2 secondary outcomes
Development of Dysphagia during ChemoRadiation Treatment
Time frame: Baseline and Up to approximately 90 days after randomization
Change in Bowel Movements
Time frame: Baseline and Up to approximately 90 days after randomization
Results and safety
The study was stopped early (reason given: Recruitment slower than anticipated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Mucositis
RecruitingObservational study
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Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
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Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
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A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
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RecruitingPhase 3
A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer.
Head & Neck Cancer, Oral Mucositis
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.
Richard Deming, MD principal investigator
MercyOne Des Moines Medical Center
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 SBI in people with Mucositis, run by MercyOne Des Moines Medical Center 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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 26 Jan 2023. 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?
The study was stopped early (reason given: Recruitment slower than anticipated). Results are not available in the source record.
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?
Development of Oral Mucositis during ChemoRadiation Treatment (time frame: Baseline and Up to approximately 90 days after randomization). 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 26 Jan 2023.