Clinical Trial: A trial for feasibility and effectiveness of preHABilitation during NEOadjuvant chemotherapy in older patients with locally advanced Esophageal cancer (Japan)

Tokyo, Sept. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059115) titled 'A trial for feasibility and effectiveness of preHABilitation during NEOadjuvant chemotherapy in older patients with locally advanced Esophageal cancer' on Sept. 18.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - National Cancer Center

Condition: Condition - Esophageal cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To investigate the feasibility, safety, and effects of prehabilitation during neoadjuvant chemotherapy in older patients with locally advanced esophageal cancer. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - The intervention domains of prehabilitation during neoadjuvant chemotherapy consist of exercise and nutritional interventions, delivered through alternating inpatient (education phase) and outpatient (self-management phase: home-based intervention) settings. Patients are instructed to use a prehabilitation notebook/diary to support self-management of exercise and nutrition. The intervention period is defined as the duration from the day following the initiation of neoadjuvant chemotherapy until the T2 assessment after completion of the final chemotherapy cycle. The number of intervention sessions corresponds to the number of chemotherapy cycles administered (minimum of 1 and maximum of 3 interventions).

Eligibility: Age-lower limit - 65 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients pathologically diagnosed with thoracic esophageal cancer (squamous cell carcinoma). Patients scheduled to undergo curative resection following neoadjuvant therapy with the DCF regimen. Patients aged 65 or more years at the time of enrollment. Patients with an ECOG Performance Status of 0 to 2. Patients capable of oral intake at the time of enrollment (Dysphagia score 2 or lower). Patients able to provide written informed consent. Patients able to understand the procedures for using an activity monitor and rehabilitation notebook. Patients prior to the initiation of neoadjuvant therapy. Key exclusion criteria - Presence of systemic infection requiring treatment. Presence of fever 38 or more degrees Celsius. Presence of psychiatric disorders or psychiatric symptoms that are judged to make participation in the trial difficult. Receiving continuous systemic administration of corticosteroids (oral or intravenous). Presence of uncontrolled hypertension. Presence of unstable angina (new onset or worsening angina within the past 3 weeks) or history of myocardial infarction within the past 6 months. Presence of severe interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema, or acute heart failure. History of cerebrovascular disease (such as cerebral infarction, intracerebral hemorrhage, or transient ischemic attack) within the past 6 months. Presence of active double cancer (*1). Any other condition judged by the principal investigator to make the patient unsuitable for enrollment in this clinical trial. Target Size - 36

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 09 Day Date of IRB - 2025 Year 09 Month 09 Day Anticipated trial start date - 2025 Year 10 Month 01 Day Last follow-up date - 2027 Year 10 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067627

Disclaimer: Curated by HT Syndication.