New Food Solutions for Cancer Patients

Food Selection Clinical Trial

— Oncofood  

Official title:

Oncofood: New Food Solutions for Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302792
• Other study ID #: Oncofood - 20139
• Status: Completed
• Phase: N/A
• Start date: June 9, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2021
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study will be divided into three stages: in Stage 1, individual interviews will be conducted with present and past cancer patients, focus groups with families/care givers of cancer patients and health care professionals (cancer specialist nurses, clinical and medical oncologists, speech and language therapists, dietitians, oncology social workers and counselors). The interviews will help collect data and gain understanding on the needs of cancer patients, barriers to current food proposals and expectations from new solutions. In subsequent stages, semi-quantitative studies will be conducted with cancer patients that require texture-modified foods (Stage 2) and patients with taste & smell alterations (Stage 3). Patients will be required to evaluate texture-modified products (developed using 3D food printing technology) and taste-optimised products (i.e. soups, mousses, fruit and vegetable beverages, dairy desserts and seasonings) developed based on the results obtained from Stage 1 above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Stage 1

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.

2. 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.

3. 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.

2. Stage 2

• Adults 18-65 years old.
• Currently undergoing oncological treatment or have undergone oncological treatment in the last 12 months and require or have required texture-modified foods in the last 12 months.
• Individuals without dietary allergies or intolerances to the foods that will be tested in the study.

3. Stage 3

• Adults 18-65 years old.
• Currently undergoing oncological treatment or have undergone oncological treatment in the last 12 months and are experiencing or have experienced taste & smell alterations in the last 12 months.
• Individuals without dietary allergies or intolerances to the foods that will be tested in the study.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Cancer Patients
• Food Selection
• Taste Disorders

Intervention

Behavioral:
• Texture-modified foods for cancer patients (Stage 2)
Participants (cancer patients that require texture-modified foods) will be expected to evaluate a maximum of three meals over a 2-weeks period.
• Taste-optimised foods for cancer patients (Stage 3)
Participants (cancer patients with taste & smell alterations) will be expected to evaluate three foods at home over a period of one month.

Locations

Country	Name	City	State
United Kingdom	Sensory Science Centre, Department of Food and Nutritional Sciences, University of Reading	Reading	Berkshire

Sponsors (5)

Lead Sponsor	Collaborator
University of Reading	AZTI Spain, Maspex Poland, Natural Machines Spain, University of Warsaw

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Amézaga J, Alfaro B, Ríos 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Food diary	Record of all that is eaten or drunk and any problems encountered during/after eating from cancer patients and relatives/caregivers of cancer patients.	7 consecutive days
Secondary	Interviews	Discussion on food related issues faced by cancer patients requiring texture-modified diets / having taste & smell alterations via interviews.	1 hour session on Stage 1 visit day 1
Secondary	Focus group	Discussion on food related issues faced by cancer patients requiring texture-modified diets / having taste & smell alterations with relatives/caregivers of cancer patients via a focus group session.	2 hour session on Stage 1 visit day 2
Secondary	Focus group	Discussion on food related issues faced by cancer patients requiring texture-modified diets / having taste & smell alterations with healthcare professionals of cancer patients via a focus group session.	2 hour session on Stage 1 visit day 3