Adherence to Exercise and Dietary Intervention in Cancer Patients

NCT05237921 | Completed

• 2 other identifiers: 178/180261_B
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Adherence; Gastrointestinal Cancer

Keywords

Body composition; Wasting; Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants that meet estimated dietary intake and exercise goals

  8 weeks

Study Arms (2)

Combined Exercise and Dietary Intervention

EXPERIMENTAL

Behavioral Intervention

Behavioral: Combined Exercise and Dietary Intervention (CEDI)

Control

OTHER

Standard Care

Behavioral: Standard Care

Interventions

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.

Combined Exercise and Dietary Intervention

Standard Care BEHAVIORAL

Standard Care

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Hospital Beatriz Ângelo: lead

Study Sites (1)

Hospital Beatriz Ângelo

Loures, Lisbon District, 2674-514, Portugal

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Cachexia; Malnutrition

Interventions

Diet Therapy; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Cravo

  Hospital da Luz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutricionist

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 14, 2022
• Study Start: June 15, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

PT (1)