Colon CancerNCT04495387
Improving Food Pleasure and Intake of Oncology Patients Receiving Chemotherapy
An observational study of Colon Cancer and Breast Cancer, run by University of Florence.
Trial summary
The global cancer burden is estimated to have risen to 18.1 million new cases in 2018 (WHO), with a trend of ongoing growth. This very frequent illness exerts tremendous physical, emotional and financial strain on individuals, families, communities and health systems. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer, Breast Cancer, Chemotherapeutic Toxicity
- What is being tested?
- Chemotherapy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Dec 2022
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data will be collected on patients that are receiving chemotherapy for breast (n=50) and colorectal cancer (n=50) as adjuvant or neo-adjuvant therapy.
Who may be able to join
- pathological diagnosis of colorectal or breast cacer
- indication to adjuvant chemotherapy for colon cancer according local guide lines
- indication to (neo)-adjuvant chemotherapy for reast cancer according local guide lines
- possiility to sign an informed consent
Who cannot join
- patients aged <18 years
- patients aged >80 years
About this study
The global cancer burden is estimated to have risen to 18.1 million new cases in 2018 (WHO), with a trend of ongoing growth. This very frequent illness exerts tremendous physical, emotional and financial strain on individuals, families, communities and health systems.
Malnutrition (under- or over-nutrition) is highly prevalent in cancer patients receiving chemotherapy and is an important predictor of morbidity, mortality, treatment response and toxicity. Alterations in taste and smell are frequently reported as side effect of chemotherapy and may contribute strongly to malnutrition and to a worsen quality of life and wellbeing social, emotional, and role functioning. There are evidences that chemotherapy influences food liking and appetite with implications for food behaviours, including food enjoyment, food preference and dietary intake. A linkage between alterations in taste and /or smell and food behaviours has been reported by some studies but not all, suggesting that there is a need for more research using common standardised methodologies and larger sample size to gain a further insight into this topic.
- Conditions
- Colon Cancer, Breast Cancer, Chemotherapeutic Toxicity
- Being tested
- Chemotherapy
- Medical subject headings
- Colonic Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
standard adjuvat chemotherapy for reast and colo cancer
| Study group | Role | What they receive |
|---|---|---|
| patients with colon cancer | Not described Receives: Drug: Chemotherapy | |
| patients with breast cancer | Not described Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of taste chemotherapy-related alterations
To better understand alteration of taste/smell and food behaviours by the self-report responses, using an adapted version of a questionnaire set up to measure taste changes due to COVID-19
Measured: the variables will be measured at four time points: before chemotherapy (T0), after 4 cycles (T1, each cycle is 21 days), at the end of chemotherapy (T2, 6 months from T0) and three months after the conclusion of the therapy (T3, 9 months from T0)
Secondary outcomes (1)
Emotions elicited by foods
Emotions elicited by foods will be measured on a selection of foods through an EmoSemio questionnaire, a self-report measure of emotion developed based on preliminary interviews
Measured: the variables will be measured at four time points: before chemotherapy (T0), after 4 cycles (T1, each cycle is 21 days), at the end of chemotherapy (T2, 6 months from T0) and three months after the conclusion of the therapy (T3, 9 months from T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study startJul 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giandomenico Roviello, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495387
- Sponsor's protocol ID
- ALTERTASTE
- Status last verified
- Apr 2021
- First submitted
- 23 Jul 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Spinelli S, Mini E, Monteleone E, Angiolini C, Roviello G. ALTERTASTE: improving food pleasure and intake of oncology patients receiving chemotherapy. Future Oncol. 2021 Jul;17(20):2573-2579. doi: 10.2217/fon-2020-0871. Epub 2021 Apr 16.
PubMed 33858202
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Food Pleasure and Intake of Oncology Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT04495387
- Acronym / sponsor ID
- ALTERTASTE
- Conditions
- Colon Cancer, Breast Cancer, Chemotherapeutic Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 31 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The global cancer burden is estimated to have risen to 18.1 million new cases in 2018 (WHO), with a trend of ongoing growth. This very frequent illness exerts tremendous physical, emotional and financial strain on individuals, families, communities and health systems.
Malnutrition (under- or over-nutrition) is highly prevalent in cancer patients receiving chemotherapy and is an important predictor of morbidity, mortality, treatment response and toxicity. Alterations in taste and smell are frequently reported as side effect of chemotherapy and may contribute strongly to malnutrition and to a worsen quality of life and wellbeing social, emotional, and role functioning. There are evidences that chemotherapy influences food liking and appetite with implications for food behaviours, including food enjoyment, food preference and dietary intake. A linkage between alterations in taste and /or smell and food behaviours has been reported by some studies but not all, suggesting that there is a need for more research using common standardised methodologies and larger sample size to gain a further insight into this topic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with colon cancer | – | Drug: Chemotherapy |
| patients with breast cancer | – | Drug: Chemotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data will be collected on patients that are receiving chemotherapy for breast (n=50) and colorectal cancer (n=50) as adjuvant or neo-adjuvant therapy.
Key inclusion criteria (4 listed)
- pathological diagnosis of colorectal or breast cacer
- indication to adjuvant chemotherapy for colon cancer according local guide lines
- indication to (neo)-adjuvant chemotherapy for reast cancer according local guide lines
- possiility to sign an informed consent
Key exclusion criteria (2 listed)
- patients aged <18 years
- patients aged >80 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapystandard adjuvat chemotherapy for reast and colo cancer | Drug | patients with breast cancer, patients with colon cancer |
Primary outcome
change of taste chemotherapy-related alterations
Time frame: the variables will be measured at four time points: before chemotherapy (T0), after 4 cycles (T1, each cycle is 21 days), at the end of chemotherapy (T2, 6 months from T0) and three months after the conclusion of the therapy (T3, 9 months from T0)
To better understand alteration of taste/smell and food behaviours by the self-report responses, using an adapted version of a questionnaire set up to measure taste changes due to COVID-19
1 secondary outcome
Emotions elicited by foods
Time frame: the variables will be measured at four time points: before chemotherapy (T0), after 4 cycles (T1, each cycle is 21 days), at the end of chemotherapy (T2, 6 months from T0) and three months after the conclusion of the therapy (T3, 9 months from T0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Derived from this study: PubMed 33858202Spinelli S, Mini E, Monteleone E, Angiolini C, Roviello G. ALTERTASTE: improving food pleasure and intake of oncology patients receiving chemotherapy. Future Oncol. 2021 Jul;17(20):2573-2579. doi: 10.2217/fon-2020-0871. Epub 2021 Apr 16.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Breast Cancer, run by University of Florence.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
change of taste chemotherapy-related alterations (time frame: the variables will be measured at four time points: before chemotherapy (T0), after 4 cycles (T1, each cycle is 21 days), at the end of chemotherapy (T2, 6 months from T0) and three months after the conclusion of the therapy (T3, 9 months from T0)). 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 NCT04495387, which also lists 1 linked publication.
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 27 Apr 2021.