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NCT05237921 Clinical Trial

Adherence to Exercise and Dietary Intervention in Cancer Patients

Gastrointestinal Cancer Clinical Trial

— CEDI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05237921
Other study ID # 178/18
Secondary ID 0261_B
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2018
Est. completion date June 30, 2022

Study information
Verified date March 2024
Source Hospital Beatriz Ângelo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients with esophageal, gastric, pancreatic and rectal cancer - Due to commence neo-adjuvant chemo/ radiotherapy (ChT) Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

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 (Forticare®, Nutricia) is given to meet the European Society of Parenteral and Enteral Nutrition (ESPEN) recommended intake.
• Standard Care
Standard Care

Locations
Country Name City State
Portugal Hospital Beatriz Ângelo Loures Lisboa

Sponsors (1)
Lead Sponsor Collaborator
Hospital Beatriz Ângelo

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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