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
• 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
• 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:

-

Related Conditions & MeSH terms

• Adherence
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

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