AdherenceCEDINCT05237921
Adherence to Exercise and Dietary Intervention in Cancer Patients
A study testing Combined Exercise and Dietary Intervention (CEDI) in people with Adherence and Gastrointestinal Cancer, run by Hospital Beatriz Ângelo at 1 site in Portugal.
Trial summary
Intervention programs in cancer patients have been proposed with the aim of improving outcome. Bearing in mind that compliance is a limiting factor to the benefit provided from exercise and diet, assessing adherence to these interventions is paramount before pursuing further studies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adherence, Gastrointestinal Cancer
- What is being tested?
- Combined Exercise and Dietary Intervention (CEDI)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Jun 2018to 30 Jun 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with esophageal, gastric, pancreatic and rectal cancer
- Due to commence neo-adjuvant chemo/ radiotherapy (ChT)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adherence to a Combined Exercise and Dietary Intervention in Patients With Gastrointestinal Cancer Undergoing Neo-adjuvant Therapy.
Intervention programs in cancer patients have been proposed with the aim of improving outcome. Bearing in mind that compliance is a limiting factor to the benefit provided from exercise and diet, assessing adherence to these interventions is paramount before pursuing further studies. Therefore the purpose of this study was to study the adherence of gastrointestinal cancer patients to a Combined Exercise and Dietary Intervention (CEDI) during neo-adjuvant chemotherapy.
- Conditions
- Adherence, Gastrointestinal Cancer
- Being tested
- Combined Exercise and Dietary Intervention (CEDI), Standard Care
- Keywords
- Body composition, Wasting, Malnutrition
- Medical subject headings
- Gastrointestinal Neoplasms, Cachexia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Exercise and Dietary Intervention (CEDI)Behavioural
Intervention aimed at conveying a supervised combined moderate aerobic and resistance training, once a week with a duration of 40-60 minutes plus daily home exercise, personalized according to patients' age and functional status.
Dietary intervention aimed at a one-on-one nutritional counseling. In the first visit a dietary plan is designed and one daily oral nutritional supplement (Forticare®, Nutricia) is given to meet the European Society of Parenteral and Enteral Nutrition (ESPEN) recommended intake.
Standard CareBehavioural
Standard Care
| Study group | Role | What they receive |
|---|---|---|
| Combined Exercise and Dietary Intervention | Experimental | Behavioral Intervention Receives: Behavioral: Combined Exercise and Dietary Intervention (CEDI) |
| Control | Other | Standard Care Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that adhere to a Combined Exercise and Dietary Intervention (CEDI)
The aim of this study was to assess intervention adherence defined as the number of participants willing to engage in CEDI.
Measured: 8 weeks
Secondary outcomes (1)
Number of participants that meet estimated dietary intake and exercise goals
We will assess the number of participants able to achieve their estimated dietary goals, namely 25-30kcal/day and 1-1.5g protein day and at least attending to 50% of planed exercise sessions.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start15 Jun 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdherenceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Beatriz Ângelo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sónia Velho, Hospital Beatriz Ângelo
- Investigators
- Cravo, Study director, Hospital da Luz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237921
- Sponsor's protocol ID
- 178/18
- Other IDs
- 0261_B
- Acronym
- CEDI
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2022
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol with statistical analysis plan will be uploaded to trials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to a Combined Exercise and Dietary Intervention in Patients With Gastrointestinal Cancer Undergoing Neo-adjuvant Therapy.
- ClinicalTrials.gov ID
- NCT05237921
- Acronym / sponsor ID
- CEDI / 178/18
- Conditions
- Adherence, Gastrointestinal Cancer
- Keywords
- Body composition, Wasting, Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Beatriz ÂngeloUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 Feb 2022 (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.
Intervention programs in cancer patients have been proposed with the aim of improving outcome. Bearing in mind that compliance is a limiting factor to the benefit provided from exercise and diet, assessing adherence to these interventions is paramount before pursuing further studies. Therefore the purpose of this study was to study the adherence of gastrointestinal cancer patients to a Combined Exercise and Dietary Intervention (CEDI) during neo-adjuvant chemotherapy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Exercise and Dietary Intervention | Experimental | Behavioral: Combined Exercise and Dietary Intervention (CEDI)Behavioral Intervention |
| Control | Other | Behavioral: Standard CareStandard Care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with esophageal, gastric, pancreatic and rectal cancer
- Due to commence neo-adjuvant chemo/ radiotherapy (ChT)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Combined Exercise and Dietary Intervention (CEDI)Intervention aimed at conveying a supervised combined moderate aerobic and resistance training, once a week with a duration of 40-60 minutes plus daily home exercise, personalized according to patients' age and functional status. Dietary intervention aimed at a one-on-one nutritional counseling. In the first visit a dietary plan is designed and one daily oral nutritional supplement (Forticare®, Nutricia) is given to meet the European Society of Parenteral and Enteral Nutrition (ESPEN) recommended intake. | Behavioural | Combined Exercise and Dietary Intervention |
| Standard CareStandard Care | Behavioural | Control |
Primary outcome
Number of participants that adhere to a Combined Exercise and Dietary Intervention (CEDI)
Time frame: 8 weeks
The aim of this study was to assess intervention adherence defined as the number of participants willing to engage in CEDI.
1 secondary outcome
Number of participants that meet estimated dietary intake and exercise goals
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: Yes. Study protocol with statistical analysis plan will be uploaded to trials.gov.
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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.
Cravo study director
Hospital da Luz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Exercise and Dietary Intervention (CEDI) in people with Adherence and Gastrointestinal Cancer, run by Hospital Beatriz Ângelo at 1 site in Portugal.
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 2 inclusion and 1 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 19 Mar 2024. 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 Portugal. 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?
Number of participants that adhere to a Combined Exercise and Dietary Intervention (CEDI) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2024.