AnorexiaNCT01941810
Bovine Lactoferrin Supplement in Improving Taste in Patients With Cancer Receiving Chemotherapy
A study testing bovine lactoferrin supplement, questionnaire administration and quality-of-life assessment in people with Anorexia and Cachexia, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
This pilot phase II trial studies how well bovine lactoferrin supplement works in improving taste in patients with cancer receiving chemotherapy. Bovine lactoferrin supplement may help improve the ability to taste food in patients who are receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorexia, Cachexia, Malignant Neoplasm
- What is being tested?
- bovine lactoferrin supplement, questionnaire administration and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to 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 carcinoma of any site; the two exceptions are pancreatic cancer and colon cancer patients who are receiving oxaliplatin; those patients will be ineligible for participation in this current study but will be eligible for Comprehensive Cancer Center of Wake Forest University (CCCWFU) 98112 instead
- There are no restrictions on the amount or types of prior therapy; eligible patients must be receiving ongoing chemotherapy that is planned to continue for at least one month following enrollment in this trial; any dose or schedule of chemotherapy administration is allowed as long as patients have self-reported taste disturbance that has either: 1) developed since the initiation of chemotherapy, or 2) a pre-existing, treatment-induced taste disturbance has subjectively worsened since initiating chemotherapy
- Patients must have normal baseline self-reported taste perception prior to the development of cancer
- 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 pregnant or breastfeeding are excluded
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Virginia Polytechnic Institute and State University
Blacksburg, Virginia, 24060
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Study of Bovine Lactoferrin in Cancer Patients Reporting Taste Disturbances While Receiving Chemotherapy
This pilot phase II trial studies how well bovine lactoferrin supplement works in improving taste in patients with cancer receiving chemotherapy. Bovine lactoferrin supplement may help improve the ability to taste food in patients who are receiving chemotherapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the impact of lactoferrin supplementation (bovine lactoferrin supplement) on self-reported taste and smell disturbances in cancer patients receiving chemotherapy.
SECONDARY OBJECTIVES:
- To assess the impact of lactoferrin supplementation on the baseline lipid peroxidation byproducts in saliva in cancer patients as measured by the thiobarbituric acid reactive substances (TBARs) assay.
II. To assess the impact of lactoferrin supplementation on the ability of cancer 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 cancer patients with established chemotherapy-induced taste disturbances.
IV. To assess the incidence of vitamin D deficiency in cancer patients with chemotherapy induced taste changes.
OUTLINE:
Patients receive bovine lactoferrin supplement orally (PO) three times daily (TID) for 1 month.
After completion of study treatment, patients are followed up at 2 weeks and 1 month.
- Being tested
- bovine lactoferrin supplement, questionnaire administration, quality-of-life assessment, laboratory biomarker analysis
- Medical subject headings
- Anorexia, Cachexia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bovine lactoferrin supplementDietary supplement
Also called bLF supplement
Given PO
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (bovine lactoferrin supplement) | Experimental | Patients receive bovine lactoferrin supplement PO TID for 1 month. Receives: Dietary Supplement: bovine lactoferrin supplement; Other: questionnaire administration; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in taste disturbances using the visual analogue scale (VAS) and the Smell and Taste Questionnaire
Tested separately by using paired t-tests to assess the significance of the baseline to one month changes.
Measured: Baseline to up to 1 month
Change in smell disturbances using the VAS and the Smell and Taste Questionnaire
Tested separately by using paired t-tests to assess the significance of the baseline to one month changes.
Measured: Baseline to up to 1 month
Secondary outcomes (4)
Effect of bovine lactoferrin supplement on lipid peroxidation byproducts as measured by the TBARs assay
Measured: Up to 2 months
Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse
Measured: Up to 2 months
Smelling loss as quantified by the Brief Smell Identification Test (B-SIT)
Measured: Up to 2 months
Quality of life as quantified by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaires
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startFeb 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnorexiaStudies 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
- 14 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
- NCT01941810
- Sponsor's protocol ID
- IRB00025192
- Other IDs
- NCI-2013-01741, CCCWFU 98513, P30CA012197
- Status last verified
- Jul 2018
- First submitted
- 10 Sep 2013
- 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 Cancer Patients Reporting Taste Disturbances While Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT01941810
- Acronym / sponsor ID
- IRB00025192
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Sep 2013 (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.
This pilot phase II trial studies how well bovine lactoferrin supplement works in improving taste in patients with cancer receiving chemotherapy. Bovine lactoferrin supplement may help improve the ability to taste food in patients who are receiving chemotherapy.
Detailed description
PRIMARY OBJECTIVES:
- To assess the impact of lactoferrin supplementation (bovine lactoferrin supplement) on self-reported taste and smell disturbances in cancer patients receiving chemotherapy.
SECONDARY OBJECTIVES:
- To assess the impact of lactoferrin supplementation on the baseline lipid peroxidation byproducts in saliva in cancer patients as measured by the thiobarbituric acid reactive substances (TBARs) assay.
II. To assess the impact of lactoferrin supplementation on the ability of cancer 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 cancer patients with established chemotherapy-induced taste disturbances.
IV. To assess the incidence of vitamin D deficiency in cancer patients with chemotherapy induced taste changes.
OUTLINE:
Patients receive bovine lactoferrin supplement orally (PO) three times daily (TID) for 1 month.
After completion of study treatment, patients are followed up at 2 weeks and 1 month.
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 supplement) | Experimental | Dietary Supplement: bovine lactoferrin supplement, Other: questionnaire administration, Procedure: quality-of-life assessment, Other: laboratory biomarker analysisPatients receive bovine lactoferrin supplement PO TID for 1 month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have histologically or cytologically confirmed carcinoma of any site; the two exceptions are pancreatic cancer and colon cancer patients who are receiving oxaliplatin; those patients will be ineligible for participation in this current study but will be eligible for Comprehensive Cancer Center of Wake Forest University (CCCWFU) 98112 instead
- There are no restrictions on the amount or types of prior therapy; eligible patients must be receiving ongoing chemotherapy that is planned to continue for at least one month following enrollment in this trial; any dose or schedule of chemotherapy administration is allowed as long as patients have self-reported taste disturbance that has either: 1) developed since the initiation of chemotherapy, or 2) a pre-existing, treatment-induced taste disturbance has subjectively worsened since initiating chemotherapy
- Patients must have normal baseline self-reported taste perception prior to the development of cancer
- Life expectancy of >= 3 months
- Ability to understand and the willingness to sign a written informed consent document
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 pregnant or 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 |
|---|---|---|
| bovine lactoferrin supplementAlso: bLF supplementGiven PO | Dietary supplement | Supportive care (bovine lactoferrin supplement) |
| questionnaire administrationAncillary studies | Other | Supportive care (bovine lactoferrin supplement) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Supportive care (bovine lactoferrin supplement) |
| laboratory biomarker analysisCorrelative studies | Other | Supportive care (bovine lactoferrin supplement) |
Primary outcome
Change in taste disturbances using the visual analogue scale (VAS) and the Smell and Taste Questionnaire
Time frame: Baseline to up to 1 month
Tested separately by using paired t-tests to assess the significance of the baseline to one month changes.
Change in smell disturbances using the VAS and the Smell and Taste Questionnaire
Time frame: Baseline to up to 1 month
Tested separately by using paired t-tests to assess the significance of the baseline to one month changes.
4 secondary outcomes
Effect of bovine lactoferrin supplement on lipid peroxidation byproducts as measured by the TBARs assay
Time frame: Up to 2 months
Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse
Time frame: Up to 2 months
Smelling loss as quantified by the Brief Smell Identification Test (B-SIT)
Time frame: Up to 2 months
Quality of life as quantified by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaires
Time frame: Up to 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bovine lactoferrin supplement, questionnaire administration and quality-of-life assessment in people with Anorexia and Cachexia, run by Wake Forest University Health Sciences at 2 sites 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 5 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 2 sites 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 taste disturbances using the visual analogue scale (VAS) and the Smell and Taste Questionnaire (time frame: Baseline to up to 1 month). The study lists 2 primary outcomes in all. 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.