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Adherence to Exercise and Dietary Intervention in Cancer Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05237921
Acronym
CEDI
Enrollment
50
Registered
2022-02-14
Start date
2018-06-15
Completion date
2022-06-30
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence, Gastrointestinal Cancer

Keywords

Body composition, Wasting, Malnutrition

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.

Interventions

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.

BEHAVIORALStandard Care

Standard Care

Sponsors

Hospital Beatriz Ângelo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients with esophageal, gastric, pancreatic and rectal cancer * Due to commence neo-adjuvant chemo/ radiotherapy (ChT)

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Number of participants that adhere to a Combined Exercise and Dietary Intervention (CEDI)8 weeksThe aim of this study was to assess intervention adherence defined as the number of participants willing to engage in CEDI.

Secondary

MeasureTime frameDescription
Number of participants that meet estimated dietary intake and exercise goals8 weeksWe 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.

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026