Gastroesophageal Junction Cancer Clinical Trials

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A Comprehensive Preoperative and Postoperative Program Consisting Of Active Physical Therapy, A Comprehensive Nutritional Plan, And Psychological Support For Patients With Locally Advanced, Resectable Cancer Of The Esophagus, Gastroesophageal Junction, and Stomach

Status: Recruiting
Intervention Type: Diagnostic test, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Perioperative chemotherapy (CHT) or CHT/RT combined with surgery is the standard therapeutic approach for the treatment of locally advanced cancer of the esophagus, gastroesophageal junction (GEJ), and stomach. Comprehensive cancer treatment is associated with high perioperative morbidity and mortality. Serious postoperative complications occur in up to 20-80% of patients undergoing esophagectomy. The impact of nutritional status and overall physical condition on surgical outcomes and overall treatment has been demonstrated many times. The concept of pre-rehabilitation/pre-optimization, which involves establishing an individualized nutritional plan, monitoring and managing physical activity, and providing comprehensive supportive oncological and psychological care as early as during neoadjuvant CHT or CHT/RT, is a prerequisite for improving perioperative and 30-day postoperative morbidity and mortality.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Consent to participate in the study

• Age ≥ 18 years

• Patients with locally advanced esophageal or gastric cancer indicated for comprehensive perioperative treatment

• Resectable disease

• ECOG performance status 0-2

• Ability to participate in a fitness program

• Willingness to follow a nutritional plan and recommendations

Contact Information
Primary
Martina Lojová, PhD
martina.lojova@mou.cz
+420543136232
Backup
Tereza Štěpánková, PhD
tereza.stepankova@mou.cz
+420543136223
Time Frame
Start Date: 2023-05-02
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Interventional
Participants undergo a multimodal prehabilitation and perioperative optimization program. Intervention includes supervised home-based exercise training prescribed according to the ACSM FITT principles for 8 weeks, incorporating inspiratory muscle training initiated at 60% of baseline maximal inspiratory pressure and progressively adjusted based on perceived exertion, together with aerobic exercise at 60-80% heart rate reserve. Training is delivered via telemedicine with regular remote supervision. Cardiorespiratory fitness is assessed at baseline, after completion of neoadjuvant therapy, and 6 months postoperatively. Participants will receive comprehensive nutritional assessment and individualized nutritional support, structured psychological counseling at predefined study time points, and perioperative care according to ERAS principles. Quality of life is evaluated using validated questionnaires. Cellular and humoral immunity and endocrine function are monitored longitudinally using
Sponsors
Leads: Masaryk Memorial Cancer Institute

This content was sourced from clinicaltrials.gov

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