Clinical trial NCT04302792: New Food Solutions for Cancer Patients
Official title: Oncofood: New Food Solutions for Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Patients
Taste Disorders
Food Selection
Keywords: taste & smell alterations
texture-modified foods
taste-optimised foods
cancer patients
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: AZTI Spain
name: Maspex Poland
name: Natural Machines Spain
name: University of Warsaw
First posted: 2020-03-10
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Acceptability of developed texture-modified food 1
timeFrame: 1 hour on Stage 2 visit day 1
measure: Acceptability of developed texture-modified food 2
timeFrame: 1 hour on Stage 2 visit day 2
measure: Acceptability of developed texture-modified food 3
timeFrame: 1 hour on Stage 2 visit day 3
measure: Acceptability of developed taste-optimised food 1
timeFrame: 1 hour on Stage 3 visit day 1
measure: Acceptability of developed taste-optimised food 2
timeFrame: 1 hour on Stage 3 visit day 2
measure: Acceptability of developed taste-optimised food 3
timeFrame: 1 hour on Stage 3 visit day 3
Secondary outcomes:
measure: Food diary
timeFrame: 7 consecutive days
measure: Interviews
timeFrame: 1 hour session on Stage 1 visit day 1
measure: Focus group
timeFrame: 2 hour session on Stage 1 visit day 2
measure: Focus group
timeFrame: 2 hour session on Stage 1 visit day 3
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Sensory Science Centre, Department of Food and Nutritional Sciences, University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Stella Lignou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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. doi: 10.1002/hed.20250.
citation: 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.