Pancreatic CancerNCT05420259
Combined Exercise and Nutritional Intervention in GI Cancer Patients
A study testing Combined Exercise and Dietary Intervention (CEDI) in people with Pancreatic Cancer and Gastric Cancer, run by Hospital Beatriz Ângelo at 2 sites in Portugal.
Trial summary
Although some studies have focused on the role of exercise on inflammation and cytokine expression in cancer patients undergoing treatment and survivors, to our knowledge none have investigated the effect of exercise during neoadjuvant treatment as a complementary therapy to 1) modulate inflammation which may have a… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pancreatic Cancer, Gastric Cancer, Diet
- 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
- 68 participants
- Where
- 2 sitesPortugal
- Study dates
- 21 Mar 2022to 28 Jun 2024
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- gastric or pancreatic cancer stage II/III, eligible for neoadjuvant chemotherapy,
- age higher than 40 years and lower than 80 years,
- ECOG (Eastern Cooperative Oncology Group) functional status: 0-2,
- sedentary/low physical activity level.
Who cannot join
- life expectancy less than 12 months at inclusion,
- chemotherapy regimen other than 5-Fluorouracil, Folinic acid, Oxaliplatin, Docetaxel (FLOT) for gastric and 5-Fluorouracil, Irinotecan and Oxaliplatin (FOLFIRINOX) or gemcitabine for pancreatic cancer,
- metastatic disease,
- chronic anti-inflammatory medication use,
- known inflammatory condition (rheumatoid arthritis, ankylosing spondylitis or chronic active hepatitis)
- cardiovascular, respiratory or musculoskeletal or joint problems that preclude moderate physical activity.
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites, 2 recruiting
- Not yet recruiting
Hospital da Luz
Lisbon
Sónia Velho
- Recruiting
Hospital Beatriz Ângelo
Loures, Lisbon District, 2674-514
Velho, +351914644141, soniavelho0@gmail.com
Sónia Velho
About this study
Official title: Influence of a Combined Dietary and Exercise Intervention on Cytokine Profile and NK Cell Activation in Cancer Patients Undergoing Neoadjuvant Treatment.
Although some studies have focused on the role of exercise on inflammation and cytokine expression in cancer patients undergoing treatment and survivors, to our knowledge none have investigated the effect of exercise during neoadjuvant treatment as a complementary therapy to 1) modulate inflammation which may have a positive influence on chemotherapy response and 2) preserve or improve skeletal muscle, thus preventing cancer cachexia. Furthermore, we believe that the neoadjuvant treatment period could be a window of opportunity to optimize patient's nutritional status before surgery, which until now has been under used.
Bearing in mind that nutritional interventions may also influence IL-6, our hypothesis is that a Combined Exercise and Dietary Intervention (CEDI) may induce positive alterations in cytokine profile and increase NK cell infiltration of the tumor in gastric and pancreatic cancer patients submitted to neo-adjuvant therapy.
- Conditions
- Pancreatic Cancer, Gastric Cancer, Diet, Exercise
- Being tested
- Combined Exercise and Dietary Intervention (CEDI), Standard Care
- Keywords
- Body composition, Wasting, Malnutrition
- Medical subject headings
- Pancreatic Neoplasms, Stomach Neoplasms, Motor Activity, 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
The exercise program will be planned by an exercise physiologist and implemented by physiotherapists prior to rehabilitation physician assessment. In the first session patients will be evaluated by physiotherapist in order to allow personalization of exercise according to patient's age and functional capacity. In regard to diet, written materials will be given to patients and caregivers, namely a dietary plan, standard menus, recipes, and standard portions information.
Standard CareBehavioural
Standard Care
| Study group | Role | What they receive |
|---|---|---|
| Combined Exercise and Dietary Intervention | Experimental | 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 (Fortimel Compact®, Nutricia) is given to meet the European Society of Parenteral and Enteral Nutrition (ESPEN) recommended intake. 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.
Mean Change in interleukin 6 (IL6)
IL6 circulating levels will be determined before and after combined exercise and dietary intervention (CEDI)
Measured: 8 weeks
Secondary outcomes (2)
Change in Immune cell infiltration profile on tumor specimen
Peri-tumoral cell distribution (NK cells, T cells) will be determined before and after combined exercise and dietary intervention (CEDI)
Measured: 8 weeks
Change in skeletal muscle
Skeletal muscle using CT scan body composition analysis will be assessed before and after combined exercise and dietary intervention (CEDI)
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 posted15 Jun 2022
- Study start21 Mar 2022
- Primary completion28 Jun 2024 (estimated)
- Study completion28 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Beatriz Ângelo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sónia Velho, Hospital Beatriz Ângelo
- Investigators
- Marilia Cravo, Study director, Hospital da Luz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420259
- Sponsor's protocol ID
- 213/18
- Status last verified
- Mar 2024
- First submitted
- 13 Jun 2022
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
- Influence of a Combined Dietary and Exercise Intervention on Cytokine Profile and NK Cell Activation in Cancer Patients Undergoing Neoadjuvant Treatment.
- ClinicalTrials.gov ID
- NCT05420259
- Acronym / sponsor ID
- 213/18
- Conditions
- Pancreatic Cancer, Gastric Cancer, Diet, Exercise
- Keywords
- Body composition, Wasting, Malnutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Hospital Beatriz ÂngeloUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 28 Jun 2024 (estimated)
- First posted
- 15 Jun 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.
Although some studies have focused on the role of exercise on inflammation and cytokine expression in cancer patients undergoing treatment and survivors, to our knowledge none have investigated the effect of exercise during neoadjuvant treatment as a complementary therapy to 1) modulate inflammation which may have a positive influence on chemotherapy response and 2) preserve or improve skeletal muscle, thus preventing cancer cachexia. Furthermore, we believe that the neoadjuvant treatment period could be a window of opportunity to optimize patient's nutritional status before surgery, which until now has been under used.
Bearing in mind that nutritional interventions may also influence IL-6, our hypothesis is that a Combined Exercise and Dietary Intervention (CEDI) may induce positive alterations in cytokine profile and increase NK cell infiltration of the tumor in gastric and pancreatic cancer patients submitted to neo-adjuvant therapy.
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)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 (Fortimel Compact®, Nutricia) is given to meet the European Society of Parenteral and Enteral Nutrition (ESPEN) recommended intake. |
| Control | Other | Behavioral: Standard CareStandard Care |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- gastric or pancreatic cancer stage II/III, eligible for neoadjuvant chemotherapy,
- age higher than 40 years and lower than 80 years,
- ECOG (Eastern Cooperative Oncology Group) functional status: 0-2,
- sedentary/low physical activity level.
Key exclusion criteria (6 listed)
- life expectancy less than 12 months at inclusion,
- chemotherapy regimen other than 5-Fluorouracil, Folinic acid, Oxaliplatin, Docetaxel (FLOT) for gastric and 5-Fluorouracil, Irinotecan and Oxaliplatin (FOLFIRINOX) or gemcitabine for pancreatic cancer,
- metastatic disease,
- chronic anti-inflammatory medication use,
- known inflammatory condition (rheumatoid arthritis, ankylosing spondylitis or chronic active hepatitis)
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)The exercise program will be planned by an exercise physiologist and implemented by physiotherapists prior to rehabilitation physician assessment. In the first session patients will be evaluated by physiotherapist in order to allow personalization of exercise according to patient's age and functional capacity. In regard to diet, written materials will be given to patients and caregivers, namely a dietary plan, standard menus, recipes, and standard portions information. | Behavioural | Combined Exercise and Dietary Intervention |
| Standard CareStandard Care | Behavioural | Control |
Primary outcome
Mean Change in interleukin 6 (IL6)
Time frame: 8 weeks
IL6 circulating levels will be determined before and after combined exercise and dietary intervention (CEDI)
2 secondary outcomes
Change in Immune cell infiltration profile on tumor specimen
Time frame: 8 weeks
Change in skeletal muscle
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- 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.
Marilia Cravo study director
Hospital da Luz
2 sites 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 Pancreatic Cancer and Gastric Cancer, run by Hospital Beatriz Ângelo at 2 sites 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 4 inclusion and 6 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 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 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sónia Velho (+351914644141, soniavelho0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in interleukin 6 (IL6) (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.