NCT07112482

Effect of Dietary Counseling and Nutritional Monitoring in Reducing Cancer-related Cachexia Among Female Oncology Patients

Assessing Cachexia Status in Pakistani Cancer Patients Using the Mini-CASCO Score

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Pakistan Society of Pediatric Oncology · Academic / Other
• Sex: Female
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

In this parallel, two-arm randomized controlled trial (RCT), 140 female patients with advanced-stage breast cancer and clinical features of cachexia will be randomized using block-stratified allocation into an intervention group (n = 70) and a control group (n = 70). The intervention group will receive standard oncological care along with personalized dietary counseling and monthly nutritional monitoring for six months, whereas the control group will receive standard care alone. The severity of cachexia will be assessed at baseline and follow-up using the Mini-CASCO tool, which will evaluate five domains: body composition, inflammatory-metabolic profile (C-reactive protein, serum albumin, hemoglobin, absolute lymphocyte count), physical performance (Eastern Cooperative Oncology Group \[ECOG\] status), anorexia (Simplified Nutritional Appetite Questionnaire \[SNAQ\]), and quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 \[EORTC QLQ-C30\]).

Detailed description

This randomized controlled trial evaluates the impact of individualized dietary counseling with ongoing nutritional monitoring on cancer cachexia severity in women with advanced breast cancer. Cancer cachexia is a multifactorial syndrome characterized by muscle wasting, anorexia, inflammation, and reduced functional status, significantly impairing quality of life and treatment tolerance. Despite its clinical relevance, targeted interventions for cachexia remain underutilized in routine oncology care. The study is designed as a two-arm, parallel-group trial comparing standard oncological care alone with standard care plus a tailored nutritional intervention. The intervention is structured to address energy and protein intake requirements using individualized plans developed by a clinical dietitian. It incorporates scheduled nutritional counseling sessions, structured adherence monitoring through food logs and checklists, and reinforcement strategies including light physical activity promotion and psychosocial support. To ensure methodological rigor, the study employs block-stratified randomization with concealed allocation using opaque, sealed envelopes. While blinding of participants and care providers is not feasible due to the nature of the intervention, outcome assessors and data analysts will be blinded to minimize bias. The primary outcome-change in cachexia severity over six months-will be evaluated using a validated multidimensional tool that captures clinical, functional, and patient-reported parameters. Data will be entered into a secure, password-protected database with built-in quality control processes, including double data entry and discrepancy checks. Missing data will be handled using multiple imputation under the assumption of missing at random. Statistical analyses will be conducted on an intention-to-treat basis, with appropriate covariate adjustment and effect size reporting. This trial is expected to provide practical evidence on the feasibility and effectiveness of structured, individualized nutritional interventions as part of supportive oncology care in resource-constrained settings.

Conditions

• Breast Cancer
• Cachexia

Interventions

Type	Name	Description
BEHAVIORAL	Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring	Participants in this group will receive: Standard oncological care (e.g., chemotherapy and routine cancer treatments) Individualized dietary counseling: Nutrition plans tailored by a clinical dietitian to meet energy needs (25-30 kcal/kg/day) and protein needs (1.2-1.5 g/kg/day), adapted to clinical status, dietary tolerance, and treatment side effects. Regular nutritional monitoring: Counseling sessions every 15-21 days over a period of six months. Dietary adherence tracking: Through structured food records and goal adherence checklists. Light physical activity guidance: Encouragement to engage in low-intensity activity suited to patient capacity. Psychosocial support: Sessions with a certified clinical psychologist addressing emotional distress, fatigue, and anorexia. Adherence criteria: Defined as attending ≥75% of sessions and meeting ≥80% of dietary goals.

Timeline

• Start date: 2024-08-15
• Primary completion: 2025-06-30
• Completion: 2025-07-15
• First posted: 2025-08-08
• Last updated: 2025-08-11

Locations

1 site across 1 country: Pakistan