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Completed

NCT Number: NCT05237921

Adherence to Exercise and Dietary Intervention in Cancer Patients

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.

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Key information

Conditions

Adherence Body Weight Body Weight Changes Cachexia Digestive System Diseases Digestive System Neoplasms Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Beatriz Ângelo

Loures, Lisbon District, 2674-514, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Combined Exercise and Dietary Intervention (CEDI)

Behavioral

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

Behavioral

Standard Care

Primary outcomes

  1. Number of participants that adhere to a Combined Exercise and Dietary Intervention (CEDI)

    Time frame: 8 weeks

    The aim of this study was to assess intervention adherence defined as the number of participants willing to engage in CEDI.

Secondary outcomes

  1. Number of participants that meet estimated dietary intake and exercise goals

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Hospital Beatriz Ângelo

Other

Registry information

Official study title

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

Acronym: CEDI

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 14, 2022
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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