Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03525236
Other study ID # 201700363
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 19, 2017
Est. completion date November 1, 2017

Study information

Verified date May 2018
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Oral nutritional supplements (ONS) are often prescribed for malnourished patients to help improve nutritional status. Commonly in cancer patients taste and smell alterations and side effects of treatment can affect the palatability and compliance to ONS. A variety of flavours and styles are available of ONS however research of the palatability of these in cancer patients is limited. This study aims to evaluate specific flavours created based on the taste changes occuring during treatment.

We aim to evaluate the patient liking and evaluation of 5 flavors in 3 different types of flavour-sensations:

- Warming/spicy sensation: to trigger the senses and bring new sensations

- Cooling/fresh sensation: to have a fresh mouthfeel and lighter base perception

- Neutral: to avoid that patients experience additional flavour and let them the opportunity to mix it with other food


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 1, 2017
Est. primary completion date November 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- > 18 years old

- Ability to complete and comprehend questionnaires provided

- Undergoing systemic cancer treatment (chemotherapy or concurrent chemoradiotherapy, radiotherapy, targeted therapy or immunotherapy)

Exclusion Criteria:

- Uncertainty about the willingness or ability of the patient to comply with the protocol requirements (no impairment and no cognitive impairments)

- Coexisting-morbidities affecting taste or smell function

- Lactose Intolerance or Galactosaemia

- Dysphagia

- Diabetics

- Food allergies/intolerances to ingredients present in the product

- No rejection of lemon, red fruits, exotic fruit, yellow fruit flavours.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Tasting of flavours
Each patient will taste 5 products, in sequential-monadic test, randomized, one by one. Patients will take few sips of each study product, ideally in isolation (avoid influence of other patients) For each product tasted the subjects will be asked to answer a questionnaire including 1 question on the palatability of the product using a 10-point hedonic scale and a more detailed organoleptic evaluation of the product. Between product tastings, participants will have a 10 minutes break to rinse their mouth and fill in a questionnaire assessing sensory changes

Locations

Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (2)

Lead Sponsor Collaborator
University Medical Center Groningen NUTRICIA

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Liking of 5 different oral nutritional supplements with adapted flavors To evaluate patient liking and perception about 5 new flavors on a 10-point scale via a sip test 20 minutes
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases