Malignant Neoplasm Clinical Trial
Official title:
Sensory Evaluation of a New Oral Nutrition Supplement in Patients at Risk for Mucositis
Verified date | November 2017 |
Source | Rutgers, The State University of New Jersey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot clinical trial studies sensory evaluation of oral nutrition supplements in patients at risk for mucositis undergoing cancer treatment. Sensory evaluation may help to obtain input about new oral nutritional supplements that may increase nutrient intake and maintain or improve nutritional status, functional capacity, and quality of life in cancer patients.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 31, 2017 |
Est. primary completion date | October 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Undergoing cancer treatment (chemotherapy, radiotherapy, and/or immunotherapy) - At risk for mucositis OR with stage I mucositis or esophagitis (i.e. radiotherapy to the head, neck, esophagus or lung OR treatment with fluorouracil (5-FU) or other chemotherapeutic agents that are known to cause mucositis or esophagitis) or at risk for xerostomia - Within the first 3 weeks of initiation of a new type of therapy - Able to read and write in English - Able to provide written informed consent Exclusion Criteria: - Food allergy to any component of the supplement - Inability to taste or smell due to medication or health condition |
Country | Name | City | State |
---|---|---|---|
United States | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Rutgers, The State University of New Jersey | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A creamy shake product with the highest total average nutrition supplement scores as assessed by questionnaires | Will identify one product from the creamy shake category with the highest total average score that will be selected to move onto further testing. The subjective assessments of each formula will be assessed and mean, standard deviation and range will be calculated for each response. There will be subjective evaluation of acceptance of the overall sensory attributes and flavor liking (9-point scale), open-ended description of sensory attributes and effects (aroma, flavor, aftertaste, off-flavors), flavor intensity, sweetness (too little, just about right, too thick) 5-point scale. In-mouth sensations (cooling, tingling, mouth wetting, refreshing, soothing, wetting) 9-point scale. | Up to 1 year | |
Primary | A tea product with the highest total average nutrition supplement scores as assessed by questionnaires | Will identify one product from the tea category with the highest total average score that will be selected to move onto further testing. The subjective assessments of each formula will be assessed and mean, standard deviation and range will be calculated for each response. There will be subjective evaluation of acceptance of the overall sensory attributes and flavor liking (9-point scale), open-ended description of sensory attributes and effects (aroma, flavor, aftertaste, off-flavors), flavor intensity, sweetness (too little, just about right, too thick) 5-point scale. In-mouth sensations (Cooling, tingling, mouth wetting, refreshing, soothing, wetting) 9-point scale. | Up to 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT02243592 -
Molecular Profiling in Tissue Samples From Patients With Cancer Who Are Exceptional Responders to Treatment
|
||
Completed |
NCT03445572 -
Meditative Slow Breathing or Isha Kriya Meditation in Improving Cancer-Related Symptoms in Hospitalized Participants With Cancer
|
N/A | |
Active, not recruiting |
NCT02860039 -
High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant
|
Phase 2 | |
Completed |
NCT01946217 -
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
|
N/A | |
Completed |
NCT01635413 -
Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)
|
N/A | |
Completed |
NCT00026169 -
Imatinib Mesylate in Treating Patients With Advanced Cancer and Kidney Failure
|
Phase 1 | |
Recruiting |
NCT04534075 -
Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial
|
Phase 3 | |
Active, not recruiting |
NCT01806129 -
Reproductive Health Program in Patients With Cancer
|
N/A | |
Recruiting |
NCT03915717 -
Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring
|
||
Recruiting |
NCT02280161 -
Germ-Line Mutations in Blood and Saliva Samples From Patients With Cancer
|
||
Recruiting |
NCT05520281 -
Short-term Psychodynamic Psychotherapy in Serious Physical Illness
|
N/A | |
Terminated |
NCT00532064 -
Cardiac Biomarkers in Early Detection of Cardiotoxicity in Patients Receiving Sunitinib or Sorafenib Chemotherapy
|
||
Completed |
NCT04990882 -
FAPI PET/CT Prospective Interobserver Agreement
|
||
Completed |
NCT01896778 -
Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer
|
N/A | |
Recruiting |
NCT05770102 -
DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Teenage/Young Adults and Paediatric Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition
|
Phase 2/Phase 3 | |
Recruiting |
NCT06090266 -
A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Recruiting |
NCT05886764 -
Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials
|
N/A | |
Completed |
NCT01506440 -
Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy
|
||
Completed |
NCT01432431 -
Spiritual Care in Improving Quality of Life of Patients, Caregivers, and Hospital Staff
|
N/A |