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Cancer PatientsOncofoodNCT04302792

New Food Solutions for Cancer Patients

A study testing Texture-modified foods for cancer patients (Stage 2) and Taste-optimised foods for cancer patients (Stage 3) in people with Cancer Patients and Taste Disorders, run by University of Reading at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cancer Patients, Taste Disorders, Food Selection
What is being tested?
Texture-modified foods for cancer patients (Stage 2) and Taste-optimised foods for cancer patients (Stage 3)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteUnited Kingdom
Study dates
9 Jun 2020to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 21Show fewer
  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Sensory Science Centre, Department of Food and Nutritional Sciences, University of Reading

    Reading, Berkshire, RG6 6AP

Other trials in United Kingdom

About this study

Official title: Oncofood: 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.

Read the 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.

Being tested
Texture-modified foods for cancer patients (Stage 2), Taste-optimised foods for cancer patients (Stage 3)
Keywords
taste & smell alterations, texture-modified foods, taste-optimised foods, cancer patients
Medical subject headings
Taste Disorders, Food Preferences

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Texture-modified foods for cancer patients (Stage 2)Behavioural

    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)Behavioural

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

Study groups in NCT04302792
Study groupRoleWhat they receive
Stage 1: Interviews and focus group sessionsNo interventionGroup 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 patientsExperimentalThe 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.
Receives: Behavioral: Texture-modified foods for cancer patients (Stage 2)
Stage 3: Taste-optimised foods for cancer patientsExperimentalThe 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.
Receives: Behavioral: Taste-optimised foods for cancer patients (Stage 3)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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".

    Measured: 1 hour on Stage 2 visit day 1

  2. 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".

    Measured: 1 hour on Stage 2 visit day 2

  3. 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".

    Measured: 1 hour on Stage 2 visit day 3

  4. 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".

    Measured: 1 hour on Stage 3 visit day 1

  5. 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".

    Measured: 1 hour on Stage 3 visit day 2

  6. 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".

    Measured: 1 hour on Stage 3 visit day 3

Secondary outcomes (4)
  1. 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.

    Measured: 7 consecutive days

  2. Interviews

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

    Measured: 1 hour session on Stage 1 visit day 1

  3. 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.

    Measured: 2 hour session on Stage 1 visit day 2

  4. 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.

    Measured: 2 hour session on Stage 1 visit day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2020
  2. Study start9 Jun 2020
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
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.
Masking
Single blind
Who is masked
Participant
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04302792
Sponsor's protocol ID
Oncofood - 20139
Acronym
Oncofood
Status last verified
Jun 2021
First submitted
28 Feb 2020
Last updated
14 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No personal identification data will be shared. The study is not under an obligation to share data, however it is possible that some of the individual (unliked / non identifiable) data will be useful in a meta analysis and, hence sharing individual participant data (IPD) will be considered.

Publications

  • 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.

    PubMed 29168190
  • 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.

    PubMed 10337648
  • 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.

    PubMed 16114007
  • 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.

    PubMed 29855774

Questions about this trial

What is this clinical trial studying?

A study testing Texture-modified foods for cancer patients (Stage 2) and Taste-optimised foods for cancer patients (Stage 3) in people with Cancer Patients and Taste Disorders, run by University of Reading at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of developed texture-modified food 1 (time frame: 1 hour on Stage 2 visit day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04302792, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.

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