NCT03228147

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

July 25, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

July 18, 2017

Last Update Submit

November 15, 2017

Conditions

EsophagitisMalignant NeoplasmMucositis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Supportive Care (nutrition supplement)

EXPERIMENTAL

Patients receive 10 different nutrition supplements PO and complete questionnaires based on each sample in a single session over 60-90 minutes.

Dietary Supplement: Nutritional SupplementationOther: Questionnaire Administration

Interventions

Nutritional SupplementationDIETARY_SUPPLEMENT

Given PO

Also known as: Supplementation
Supportive Care (nutrition supplement)
Questionnaire AdministrationOTHER

Ancillary studies

Supportive Care (nutrition supplement)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Food allergy to any component of the supplement
  • Inability to taste or smell due to medication or health condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

EsophagitisNeoplasmsMucositis

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Salma Jabbour

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 24, 2017

Study Start

July 25, 2017

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

US(1)