Colorectal CancerNCT01596634
Bovine Lactoferrin in Reducing Taste Disturbances in Patients With Colorectal Cancer Receiving Oxaliplatin-Based Chemotherapy
A study testing questionnaire administration, quality-of-life assessment and laboratory biomarker analysis in people with Colorectal Cancer and Dysgeusia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to determine if using a lactoferrin supplement will improve taste perception. Lactoferrin is a type of protein that is naturally produced in the body and is commonly found in saliva. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Dysgeusia, Oral Complications of Chemotherapy
- What is being tested?
- questionnaire administration, quality-of-life assessment and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 10 Oct 2015
- Phase
- Interventional
- 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
- Patients must have histologically or cytologically confirmed colorectal carcinoma
- There are no restrictions on the amount or types of prior therapy
- Eligible patients must be receiving ongoing chemotherapy with an oxaliplatin containing-regimen which is planned to continue for at least one month following enrollment in this trial
- Any dose or schedule of oxaliplatin administration is allowed as long as patients have self-reported taste disturbance that has either:
- 1) developed since the initiation of oxaliplatin-based therapy, or
- 2) a pre-existing, treatment-induced taste disturbance has subjectively worsened since initiating oxaliplatin-based therapy
Show all 9Show fewer
- Patients must have normal baseline self-reported taste perception prior to the development of colorectal carcinoma
- Life expectancy of >= 3 months
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients with a subjective history of an extreme dry mouth syndrome that prevents them from producing adequate amounts of saliva (approximately 2 mL in 15-20 min)
- Patients known to be human immunodeficiency virus (HIV)-positive
- Patients with any of the following conditions: untreated gastrointestinal reflux disease; untreated diabetes mellitus; active thrush; active oral infection; active mucositis
- Patients who are known to be pregnant or who are breastfeeding are excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Study of Bovine Lactoferrin in Patients With Colorectal Carcinoma Receiving Oxaliplatin-Based Chemotherapy and Self-Reported Taste Disturbances
The purpose of this research study is to determine if using a lactoferrin supplement will improve taste perception. Lactoferrin is a type of protein that is naturally produced in the body and is commonly found in saliva.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the impact of lactoferrin (bovine lactoferrin) supplementation on self-reported taste and smell disturbances in patients with colorectal cancer receiving oxaliplatin-based chemotherapy
SECONDARY OBJECTIVES:
- To assess the impact of lactoferrin supplementation on the baseline lipid peroxidation byproducts in saliva in these patients as measured by the thiobarbituric acid-reactive substances (TBARs) assay.
II. To assess the impact of lactoferrin supplementation on the ability of these patients to generate increased lipid peroxidation byproducts when challenged with a weak iron containing solution.
III. To assess the impact of lactoferrin supplementation on self-reported general quality of life and on specific self-reported anorexia/cachexia issues in patients with established chemotherapy-induced taste disturbances.
IV. To assess the incidence of vitamin D deficiency in patients with oxaliplatin-based therapy induced taste changes
OUTLINE:
Patients receive bovine lactoferrin orally (PO) (rinse or tablet) thrice daily (TID) for 1 month. Treatment continues in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 and 4 weeks.
- Being tested
- questionnaire administration, quality-of-life assessment, laboratory biomarker analysis, bovine lactoferrin
- Medical subject headings
- Colorectal Neoplasms, Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
laboratory biomarker analysisOther
Correlative studies
bovine lactoferrinDietary supplement
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (bovine lactoferrin) | Experimental | Patients receive bovine lactoferrin PO (rinse or tablet) TID for 1 month. Treatment continues in the absence of unacceptable toxicity. Receives: Other: questionnaire administration; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis; Dietary Supplement: bovine lactoferrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses
Paired-tests will be used to assess the significance of these changes. Linear regression models will be used to determine which patient covariates are associated with change. Repeated measures models will also be used to assess the changes over time using all the repeated measures and contrasts will be used to assess individual pair-wise differences. Descriptive reports will consist of summary statistics (means, standard deviations, proportions, etc.).
Measured: Approximately 1 month
Secondary outcomes (3)
Effect of bovine lactoferrin on lipid peroxidation byproducts in saliva as measured by the TBARs assay
Measured: Approximately 2 months
Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse
Measured: Approximately 2 months
Quality of life as quantified by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) questionnaire
Measured: Approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startJan 2013
- Primary completionAug 2015
- Study completion10 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Glenn Lesser, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596634
- Sponsor's protocol ID
- IRB00020136
- Other IDs
- NCI-2012-00279, CCCWFU 98112
- Status last verified
- Jul 2018
- First submitted
- 9 May 2012
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Bovine Lactoferrin in Patients With Colorectal Carcinoma Receiving Oxaliplatin-Based Chemotherapy and Self-Reported Taste Disturbances
- ClinicalTrials.gov ID
- NCT01596634
- Acronym / sponsor ID
- IRB00020136
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2013 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- 10 Oct 2015 (actual)
- First posted
- 11 May 2012 (estimated)
- 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 research study is to determine if using a lactoferrin supplement will improve taste perception. Lactoferrin is a type of protein that is naturally produced in the body and is commonly found in saliva.
Detailed description
PRIMARY OBJECTIVES:
- To assess the impact of lactoferrin (bovine lactoferrin) supplementation on self-reported taste and smell disturbances in patients with colorectal cancer receiving oxaliplatin-based chemotherapy
SECONDARY OBJECTIVES:
- To assess the impact of lactoferrin supplementation on the baseline lipid peroxidation byproducts in saliva in these patients as measured by the thiobarbituric acid-reactive substances (TBARs) assay.
II. To assess the impact of lactoferrin supplementation on the ability of these patients to generate increased lipid peroxidation byproducts when challenged with a weak iron containing solution.
III. To assess the impact of lactoferrin supplementation on self-reported general quality of life and on specific self-reported anorexia/cachexia issues in patients with established chemotherapy-induced taste disturbances.
IV. To assess the incidence of vitamin D deficiency in patients with oxaliplatin-based therapy induced taste changes
OUTLINE:
Patients receive bovine lactoferrin orally (PO) (rinse or tablet) thrice daily (TID) for 1 month. Treatment continues in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 and 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (bovine lactoferrin) | Experimental | Other: questionnaire administration, Procedure: quality-of-life assessment, Other: laboratory biomarker analysis, Dietary Supplement: bovine lactoferrinPatients receive bovine lactoferrin PO (rinse or tablet) TID for 1 month. Treatment continues in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have histologically or cytologically confirmed colorectal carcinoma
- There are no restrictions on the amount or types of prior therapy
- Eligible patients must be receiving ongoing chemotherapy with an oxaliplatin containing-regimen which is planned to continue for at least one month following enrollment in this trial
- Any dose or schedule of oxaliplatin administration is allowed as long as patients have self-reported taste disturbance that has either:
- Patients must have normal baseline self-reported taste perception prior to the development of colorectal carcinoma
Key exclusion criteria (4 listed)
- Patients with a subjective history of an extreme dry mouth syndrome that prevents them from producing adequate amounts of saliva (approximately 2 mL in 15-20 min)
- Patients known to be human immunodeficiency virus (HIV)-positive
- Patients with any of the following conditions: untreated gastrointestinal reflux disease; untreated diabetes mellitus; active thrush; active oral infection; active mucositis
- Patients who are known to be pregnant or who are breastfeeding are excluded
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 |
|---|---|---|
| questionnaire administrationAncillary studies | Other | Supportive care (bovine lactoferrin) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Supportive care (bovine lactoferrin) |
| laboratory biomarker analysisCorrelative studies | Other | Supportive care (bovine lactoferrin) |
| bovine lactoferrinGiven PO | Dietary supplement | Supportive care (bovine lactoferrin) |
Primary outcome
Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses
Time frame: Approximately 1 month
Paired-tests will be used to assess the significance of these changes. Linear regression models will be used to determine which patient covariates are associated with change. Repeated measures models will also be used to assess the changes over time using all the repeated measures and contrasts will be used to assess individual pair-wise differences. Descriptive reports will consist of summary statistics (means, standard deviations, proportions, etc.).
3 secondary outcomes
Effect of bovine lactoferrin on lipid peroxidation byproducts in saliva as measured by the TBARs assay
Time frame: Approximately 2 months
Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse
Time frame: Approximately 2 months
Quality of life as quantified by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) questionnaire
Time frame: Approximately 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
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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.
Glenn Lesser principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire administration, quality-of-life assessment and laboratory biomarker analysis in people with Colorectal Cancer and Dysgeusia, run by Wake Forest University Health Sciences 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 9 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 3 Jul 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses (time frame: Approximately 1 month). 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 3 Jul 2018.