Online Exercise Program During Perioperative Treatment in Adults With Gastric Cancer

NCT ID: NCT06254300

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-23

Study Completion Date

2025-12-31

Brief Summary

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Perioperative chemotherapy with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT4) is the standard perioperative treatment for resectable and advanced gastric adenocarcinoma. Although the FLOT4 regimen have shown increases in the overall survival, response rate, and progression-free survival, it is also associated with substantial toxicities. Prehabilitation is an effective strategy to improve physical fitness in cancer patients and reverse functional limitations and inadequate levels of physical activity that are associated with worse postoperative outcomes and treatment response. Therefore, the main objective of this study is to evaluate the effects of an online, supervised exercise-based prehabilitation program on the cardiorespiratory fitness level, functional fitness and quality of life among adults with gastric cancer undergoing neoadjuvant chemotherapy.

Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention Group

The intervention group will participate in a supervised online exercise prehabilitation program that will extend throughout the chemotherapy until one week before the scheduled surgery. The exercise program will consist of three sessions per week, each lasting 60 minutes. The design of the prehabilitation program is based on exercise prescription recommendations for cancer survivors and will be tailored to each patient's initial functional capacity. The exercise sessions will be conducted at home through an online platform, enabling real-time interaction among groups of patients.

Group Type EXPERIMENTAL

Exercise Training

Intervention Type BEHAVIORAL

The exercise program will consist of three sessions per week, each lasting 60 minutes. The aerobic exercise will gradually increase the duration throughout the program to 40 minutes and exercise intensity from 30% to 59% of heart rate reserve. The resistance training will include bodyweight functional exercises and resistance exercises using elastic bands. The intensity of resistance exercise will progressively increase according to levels of progressive length and resistance of the elastic bands. The volume of resistance training will start with one set of 8 repetions. It will then gradually increase alongside the program to 2 sets of 12 repetitions. Participants will also be guided to assess their subjective effort using the Borg scale (RPE 12-15).

Control Group

Participants from the control group will be offered optimal medical care, which includes general advice about healthy lifestyle including regular physical activity participation according to the current guidelines.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise Training

The exercise program will consist of three sessions per week, each lasting 60 minutes. The aerobic exercise will gradually increase the duration throughout the program to 40 minutes and exercise intensity from 30% to 59% of heart rate reserve. The resistance training will include bodyweight functional exercises and resistance exercises using elastic bands. The intensity of resistance exercise will progressively increase according to levels of progressive length and resistance of the elastic bands. The volume of resistance training will start with one set of 8 repetions. It will then gradually increase alongside the program to 2 sets of 12 repetitions. Participants will also be guided to assess their subjective effort using the Borg scale (RPE 12-15).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years.
* Willingness to participate in the study.
* Referral for surgical treatment for gastric cancer.
* Diagnosis of gastric cancer for curative intent - stage II/III
* Referall to the perioperative FLOT4 chemotherapy regimen
* ECOG PS 0-1.
* Receptiveness and availability to use the proposed technology for exercise sessions

Exclusion Criteria

* Inability to provide informed consent
* Inability to engage in physical training or perform the baseline walking test
* Presence of distant metastatic disease
* History of previous or concurrent malignancy
* Diagnosis of heart failure, ischemic heart disease, or sinus node valvular disease
* Pregnancy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maia

OTHER

Sponsor Role lead

Responsible Party

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Lia Bahut

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centro Hospitalar de Vila Nova de Gaia/Espinho

Vila Nova de Gaia, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Lia F Bahut, MSc

Role: CONTACT

+351 22 986 6000

Alberto Alves, PhD

Role: CONTACT

+351 22 986 6000

Facility Contacts

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Sandra Custódio, MD

Role: primary

Andreia Capela, MD

Role: backup

Other Identifiers

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On4Cancer

Identifier Type: -

Identifier Source: org_study_id

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