Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059146) titled 'A Study to Test a Combined Program to Prevent Muscle Loss in Patients with Nasopharyngeal Cancer Receiving Chemotherapy and Radiotherapy' on Oct. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - St. Luke's International University

Condition: Condition - Nasopharyngeal carcinoma (NPC) undergoing definitive chemoradiotherapy Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This pilot randomized controlled trial aims to (1) assess the feasibility of implementing a multimodal nonpharmacological intervention model for sarcopenia prevention in nasopharyngeal carcinoma patients undergoing definitive chemoradiotherapy, and (2) estimate the effect size of the intervention on clinical outcomes to inform the design of a future full-scale randomized controlled trial. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Initial Assessment and Planning: The head nurse (PI) leads the MDT to assess each patient fully. A personalized plan with nutrition and exercise is made. The head nurse supervises the intervention.

Personalized Health Education : Four face-to-face sessions are done by nurses with a family member. Topics cover disease info, psychological prep, side effects, immune nutrition, and safe exercise. Patients and family keep weekly 3-day food and exercise logs for feedback.

Weekly Monitoring: Starting from induction chemotherapy, nurses assess diet, body status, symptoms, and adherence weekly. Nurses give advice to help meet goals.

MDT Case Consultations: The head nurse sets MDT meetings for special cases for group review and tailored care.

Key MDT Meetings: Meetings at key points present assessments, discuss issues, and update plans.

Final Review: After intervention ends, MDT reviews the case to assess results and guide future work. Interventions/Control_2 - Participants in the control group will receive the standard care currently practiced at the study hospital. This includes routine nutritional and physical activity education provided by nurses at the time of diagnosis, along with nutritional risk screening conducted by physicians using the Nutritional Risk Screening 2002 (NRS-2002) tool. When clinically indicated, such as in cases of significant weight loss, patients will be referred to a dietitian through an internal system for a one-time assessment and individualized dietary advice. However, ongoing nutritional follow-up is not routinely provided. Exercise guidance is limited to general recommendations during initial education and is not tailored or systematically monitored. Sarcopenia screening and structured tracking of physical activity are not standard components of usual care. Side effects are assessed and managed by physicians and nurses during regular outpatient visits, although this is not supported by a standardized symptom-monitoring protocol.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - The inclusion criteria for eligible patients are: Participants must have a confirmed diagnosis of nasopharyngeal carcinoma by histology and be undergoing initial concurrent chemoradiotherapy. They must be between 18 and 80 years old, have an ECOG performance status from 0 to 2, have intact limb function, and have at least one family member who can attend health education sessions and assessments with them. Key exclusion criteria - The exclusion criteria include patients having: sarcopenia and/or other malignant tumors before treatment, mental illness or cognitive impairment,implanted pacemakers,hearing or visual impairments or aphasia, and physical activity restrictions due to multiple cardiovascular diseases, poorly con-trolled hypertension, or bronchial asthma. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 06 Month 10 Day Date of IRB - 2025 Year 09 Month 01 Day Anticipated trial start date - 2025 Year 09 Month 10 Day Last follow-up date - 2026 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066489

Disclaimer: Curated by HT Syndication.