- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2022-03-21
2024-06-28
2024-06-28
68
NCT05420259
Hospital Beatriz Ângelo
Hospital Beatriz Ângelo
INTERVENTIONAL
Combined Exercise and Nutritional Intervention in GI Cancer Patients
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-06-13 | N/A | 2024-03-18 |
2022-06-13 | N/A | 2024-03-19 |
2022-06-15 | N/A | 2024-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Other
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Combined Exercise and Dietary Intervention 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 | BEHAVIORAL: Combined Exercise and Dietary Intervention (CEDI)
|
| OTHER: Control Standard Care | BEHAVIORAL: Standard Care
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Mean Change in interleukin 6 (IL6) | IL6 circulating levels will be determined before and after combined exercise and dietary intervention (CEDI) | 8 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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) | 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) | 8 weeks |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Sónia Velho Phone Number: +351914644141 Email: soniavelho0@gmail.com |
Study Contact Backup Name: Marilia Cravo Phone Number: 919439192 Email: marilia.cravo@sapo.pt |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
40 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
