Back to resultsAdherence to Exercise and Dietary Intervention in Cancer Patients (CEDI)
Primary Purpose
Adherence, Gastrointestinal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Combined Exercise and Dietary Intervention (CEDI)
Standard Care
Sponsored by
About this trial
This is an interventional other trial for Adherence focused on measuring Body composition, Wasting, Malnutrition
Eligibility Criteria
Inclusion Criteria:
- Patients with esophageal, gastric, pancreatic and rectal cancer
- Due to commence neo-adjuvant chemo/ radiotherapy (ChT)
Exclusion Criteria:
-
Sites / Locations
- Hospital Beatriz ÂngeloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Combined Exercise and Dietary Intervention
Control
Arm Description
Behavioral Intervention
Standard Care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05237921
First Posted
January 31, 2022
Last Updated
February 9, 2022
Sponsor
Hospital Beatriz Ângelo
1. Study Identification
Unique Protocol Identification Number
NCT05237921
Brief Title
Adherence to Exercise and Dietary Intervention in Cancer Patients
Acronym
CEDI
Official Title
Adherence to a Combined Exercise and Dietary Intervention in Patients With Gastrointestinal Cancer Undergoing Neo-adjuvant Therapy.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Beatriz Ângelo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adherence, Gastrointestinal Cancer
Keywords
Body composition, Wasting, Malnutrition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combined Exercise and Dietary Intervention
Arm Type
Experimental
Arm Description
Behavioral Intervention
Arm Title
Control
Arm Type
Other
Arm Description
Standard Care
Intervention Type
Behavioral
Intervention Name(s)
Combined Exercise and Dietary Intervention (CEDI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Standard Care
Primary Outcome Measure Information:
Title
Number of participants that adhere to a Combined Exercise and Dietary Intervention (CEDI)
Description
The aim of this study was to assess intervention adherence defined as the number of participants willing to engage in CEDI.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of participants that meet estimated dietary intake and exercise goals
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with esophageal, gastric, pancreatic and rectal cancer
Due to commence neo-adjuvant chemo/ radiotherapy (ChT)
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Velho
Phone
+351914644141
Email
soniavelho0@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cravo
Phone
919439192
Email
marilia.cravo@sapo.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cravo
Organizational Affiliation
Hospital da Luz
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Beatriz Ângelo
City
Loures
State/Province
Lisboa
ZIP/Postal Code
2674-514
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Velho
Phone
+351914644141
Email
soniavelho0@gmail.com
First Name & Middle Initial & Last Name & Degree
Sónia Velho
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol with statistical analysis plan will be uploaded to trials.gov.
Learn more about this trial
Adherence to Exercise and Dietary Intervention in Cancer Patients
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