Adherence to Exercise and Dietary Intervention in Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Adherence to a Combined Exercise and Dietary Intervention in Patients With Gastrointestinal Cancer Undergoing Neo-adjuvant Therapy.

Conditions
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Adherence, Gastrointestinal Cancer

Intervention / Treatment
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* Behavioral: Combined Exercise and Dietary Intervention (CEDI)
* Behavioral: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with esophageal, gastric, pancreatic and rectal cancer Due to commence neo-adjuvant chemo/ radiotherapy (ChT) Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined Exercise and Dietary Intervention<br>Behavioral Intervention | Behavioral: Combined Exercise and Dietary Intervention (CEDI)<br>* 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.<br>|
| Other: Control<br>Standard Care | Behavioral: Standard Care<br>* Standard Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body composition, Wasting, Malnutrition