New Food Solutions for Cancer Patients

NCT04302792 | Completed

• 1 other identifier: Oncofood - 20139
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The ONCOFOOD project aims to design and develop new innovative food solutions for cancer patients, taking into account not only their nutritional requirements but also their sensory changes, promoting eating pleasure and preventing malnutrition. Research involving cancer patients but also their families and health care professionals is a key element of this approach to ensure the success of the developed products for the target group.

Conditions

Cancer Patients; Taste Disorders; Food Selection

Keywords

taste & smell alterations; texture-modified foods; taste-optimised foods; cancer patients

Outcome Measures

Primary Outcomes (6)

• Acceptability of developed texture-modified food 1

  Acceptability of texture-modified food 1 using a questionnaire. Participants will be asked to rate their liking of appearance, aroma, taste, texture and overall using a 9-point hedonic scale where 1 is "dislike extremely" and 9 is "like extremely". They will also be asked to indicate their preference in comparison to usual products using a 5-point scale where 1 is "I much preferred this product to my usual products" and 5 is "I much prefer my usual products to this one". They will be asked to indicate whether they would buy this product using a 5-point scale where 1 is "definitely would buy" and 5 is "definitely would not buy".

  1 hour on Stage 2 visit day 1

• Acceptability of developed texture-modified food 2

  Acceptability of texture-modified food 2 using a questionnaire. Participants will be asked to rate their liking of appearance, aroma, taste, texture and overall using a 9-point hedonic scale where 1 is "dislike extremely" and 9 is "like extremely". They will also be asked to indicate their preference in comparison to usual products using a 5-point scale where 1 is "I much preferred this product to my usual products" and 5 is "I much prefer my usual products to this one". They will be asked to indicate whether they would buy this product using a 5-point scale where 1 is "definitely would buy" and 5 is "definitely would not buy".

  1 hour on Stage 2 visit day 2

• Acceptability of developed texture-modified food 3

  Acceptability of texture-modified food 3 using a questionnaire. Participants will be asked to rate their liking of appearance, aroma, taste, texture and overall using a 9-point hedonic scale where 1 is "dislike extremely" and 9 is "like extremely". They will also be asked to indicate their preference in comparison to usual products using a 5-point scale where 1 is "I much preferred this product to my usual products" and 5 is "I much prefer my usual products to this one". They will be asked to indicate whether they would buy this product using a 5-point scale where 1 is "definitely would buy" and 5 is "definitely would not buy".

  1 hour on Stage 2 visit day 3

• Acceptability of developed taste-optimised food 1

  Acceptability of taste-optimised food 1 using a questionnaire. Participants will be asked to rate their liking of appearance, aroma, taste, texture and overall using a 9-point hedonic scale where 1 is "dislike extremely" and 9 is "like extremely". They will also be asked to indicate their preference in comparison to usual products using a 5-point scale where 1 is "I much preferred this product to my usual products" and 5 is "I much prefer my usual products to this one". They will be asked to indicate whether they would buy this product using a 5-point scale where 1 is "definitely would buy" and 5 is "definitely would not buy".

  1 hour on Stage 3 visit day 1

• Acceptability of developed taste-optimised food 2

  Acceptability of taste-optimised food 2 using a questionnaire. Participants will be asked to rate their liking of appearance, aroma, taste, texture and overall using a 9-point hedonic scale where 1 is "dislike extremely" and 9 is "like extremely". They will also be asked to indicate their preference in comparison to usual products using a 5-point scale where 1 is "I much preferred this product to my usual products" and 5 is "I much prefer my usual products to this one". They will be asked to indicate whether they would buy this product using a 5-point scale where 1 is "definitely would buy" and 5 is "definitely would not buy".

  1 hour on Stage 3 visit day 2

• Acceptability of developed taste-optimised food 3

  Acceptability of taste-optimised food 3 using a questionnaire. Participants will be asked to rate their liking of appearance, aroma, taste, texture and overall using a 9-point hedonic scale where 1 is "dislike extremely" and 9 is "like extremely". They will also be asked to indicate their preference in comparison to usual products using a 5-point scale where 1 is "I much preferred this product to my usual products" and 5 is "I much prefer my usual products to this one". They will be asked to indicate whether they would buy this product using a 5-point scale where 1 is "definitely would buy" and 5 is "definitely would not buy".

  1 hour on Stage 3 visit day 3

Secondary Outcomes (4)

• Food diary

  7 consecutive days

• Interviews

  1 hour session on Stage 1 visit day 1

• Focus group

  2 hour session on Stage 1 visit day 2

• Focus group

  2 hour session on Stage 1 visit day 3

Study Arms (3)

Stage 1: Interviews and focus group sessions

NO INTERVENTION

Group A: Cancer patients (requiring or have required texture-modified foods and/or experiencing or have experienced taste\&smell alterations in the last 12 months) will be required to attend a one-hour online interview. Group B: Relatives of cancer patients (requiring texture-modified foods and/or experiencing taste\&smell alterations) will be required to attend a 2-hour online focus group session. Group C: Healthcare professionals with a minimum of a year's experience with oncological patients that require texture-modified foods and/or have taste \& smell alteration will be required to attend a 2-hour online focus group session. A food diary will be given to Group A and B to complete for 7-days prior to their session. Topics to be discussed during the interview and the focus group sessions will include the food requirements of cancer patients, the barriers of the current food products, possible solutions to these requirements if any and their expectations towards new food solutions.

Stage 2: Texture-modified foods for cancer patients

EXPERIMENTAL

The study will involve conducting a tasting trial over a 2-weeks period where participants will be required to consume a maximum of three 3D printed texture-modified food based on the findings from Stage 1 and evaluate the food product by completing a structured questionnaire. Key questions areas covered by the questionnaire include appetite, sensory characteristics of the product (taste, flavour, mouthfeel/texture and smell), liking and acceptability, purchase intent and best place to buy the products; questions will involve rating scales as well as qualitative comments.

Behavioral: Texture-modified foods for cancer patients (Stage 2)

Stage 3: Taste-optimised foods for cancer patients

EXPERIMENTAL

The study will involve conducting a home test over a one-month period where participants will be required to consume taste-optimised products based on the findings from Stage 1 and evaluate the food product by completing a structured questionnaire. Key questions areas covered by the questionnaire include appetite, sensory characteristics of the product (taste, flavour, mouthfeel/texture and smell), liking and acceptability, purchase intent and best place to buy the products; questions will involve rating scales as well as qualitative comments.

Behavioral: Taste-optimised foods for cancer patients (Stage 3)

Interventions

Texture-modified foods for cancer patients (Stage 2) BEHAVIORAL

Participants (cancer patients that require texture-modified foods) will be expected to evaluate a maximum of three meals over a 2-weeks period.

Stage 2: Texture-modified foods for cancer patients

Taste-optimised foods for cancer patients (Stage 3) BEHAVIORAL

Participants (cancer patients with taste \& smell alterations) will be expected to evaluate three foods at home over a period of one month.

Stage 3: Taste-optimised foods for cancer patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage 1
• Group A - Patients
• Adults 18-65 years old.
• Currently undergoing oncological treatment or have undergone oncological treatment in the last 12 months.
• Patients that require or have required texture-modified foods and/ or experience or have experienced taste \& smell alterations in the last 12 months.
• Group B - Relatives and caregivers
• Over 18 years old.
• Relative or caregiver of an adult oncological patient (that require texture-modified foods and/ or experience taste \& smell alterations).
• Living/caring for someone that is currently undergoing or have undergone oncological treatment.
• Participates actively in cooking and buying food for a household of which the person currently undergoing oncological treatment is a member.
• Group C - Healthcare professionals
• Dietitians, speech and language therapists, medical/clinical oncologists, cancer specialist nurses, and oncology social workers and counselors.
• Minimum of a year's experience with oncological patients that require texture-modified foods and/or having taste \& smell alterations.
• Stage 2
• Adults 18-65 years old.

You may not qualify if:

• Individuals below 18 years old will be excluded from the study.
• Individuals with dietary intolerances or allergies to the foods that will be tested in the study (Stages 2 and 3 only).
• Individuals who do not have the ability or capacity to consent.
• Individuals who are nil by mouth or have nasal gastric tubes of other feeding tubes inserted.
• Individuals who need modified solid and liquid diets due to problems with swallowing (Stage 3 only).

Sponsors & Collaborators

• University of Reading: lead
• AZTI Spain: collaborator
• Maspex Poland: collaborator
• Natural Machines Spain: collaborator
• University of Warsaw: collaborator

Study Sites (1)

Sensory Science Centre, Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

Related Publications (4)

• Tueros I, Uriarte M. Innovative food products for cancer patients: future directions. J Sci Food Agric. 2018 Mar;98(5):1647-1652. doi: 10.1002/jsfa.8789. Epub 2017 Dec 6.

  PMID: 29168190 BACKGROUND

• Wickham RS, Rehwaldt M, Kefer C, Shott S, Abbas K, Glynn-Tucker E, Potter C, Blendowski C. Taste changes experienced by patients receiving chemotherapy. Oncol Nurs Forum. 1999 May;26(4):697-706.

  PMID: 10337648 BACKGROUND

• Lovell SJ, Wong HB, Loh KS, Ngo RY, Wilson JA. Impact of dysphagia on quality-of-life in nasopharyngeal carcinoma. Head Neck. 2005 Oct;27(10):864-72. doi: 10.1002/hed.20250.

  PMID: 16114007 BACKGROUND

• Amezaga J, Alfaro B, Rios Y, Larraioz A, Ugartemendia G, Urruticoechea A, Tueros I. Assessing taste and smell alterations in cancer patients undergoing chemotherapy according to treatment. Support Care Cancer. 2018 Dec;26(12):4077-4086. doi: 10.1007/s00520-018-4277-z. Epub 2018 May 31.

  PMID: 29855774 BACKGROUND

MeSH Terms

Conditions

Taste Disorders; Food Preferences

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Stella Lignou, PhD

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All samples provided to the participant are labelled with 3 digit random codes.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Sensory and Consumer Science

Model Details: This is a 3 stage study design. The first stage will be a qualitative part with interviews and focus group sessions. In the second and third stages participants will evaluate food products. The second and third stages of the study will be conducted single blind as it is not feasible to blind the researcher.

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 10, 2020
• Study Start: June 9, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)