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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | Other | Standard Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Exercise and Dietary Intervention (CEDI) | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sónia Velho | Contact | +351914644141 | soniavelho0@gmail.com | |
| Marilia Cravo | Contact | 919439192 | marilia.cravo@sapo.pt |
| Name | Affiliation | Role |
|---|---|---|
| Marilia Cravo | Hospital da Luz | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Beatriz Ângelo | Recruiting | Loures | Lisbon District | 2674-514 | Portugal |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D013274 | Stomach Neoplasms |
| D009043 | Motor Activity |
| D002100 | Cachexia |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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|
| Standard Care | Behavioral | Standard Care |
|
Skeletal muscle using CT scan body composition analysis will be assessed before and after combined exercise and dietary intervention (CEDI)
| 8 weeks |
| Hospital da Luz | Not yet recruiting | Lisbon | Portugal |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D001519 | Behavior |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D006298 |
| Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |