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Completed

NCT Number: NCT04302792

New Food Solutions for Cancer Patients

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.

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Key information

Conditions

Cancer Patients Behavior Feeding Behavior Food Preferences Food Selection Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Taste Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Reading, Berkshire, RG6 6AP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.
  • 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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Acceptability of developed texture-modified food 1

    Time frame: 1 hour on Stage 2 visit day 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".

  2. Acceptability of developed texture-modified food 2

    Time frame: 1 hour on Stage 2 visit day 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".

  3. Acceptability of developed texture-modified food 3

    Time frame: 1 hour on Stage 2 visit day 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".

  4. Acceptability of developed taste-optimised food 1

    Time frame: 1 hour on Stage 3 visit day 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".

  5. Acceptability of developed taste-optimised food 2

    Time frame: 1 hour on Stage 3 visit day 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".

  6. Acceptability of developed taste-optimised food 3

    Time frame: 1 hour on Stage 3 visit day 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".

Secondary outcomes

  1. Food diary

    Time frame: 7 consecutive days

    Record of all that is eaten or drunk and any problems encountered during/after eating from cancer patients and relatives/caregivers of cancer patients.

  2. Interviews

    Time frame: 1 hour session on Stage 1 visit day 1

    Discussion on food related issues faced by cancer patients requiring texture-modified diets / having taste & smell alterations via interviews.

  3. Focus group

    Time frame: 2 hour session on Stage 1 visit day 2

    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.

  4. Focus group

    Time frame: 2 hour session on Stage 1 visit day 3

    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.

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • AZTI Spain
  • Maspex Poland
  • Natural Machines Spain
  • University of Warsaw

Registry information

Official study title

Oncofood: New Food Solutions for Cancer Patients

Acronym: Oncofood

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2020
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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