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

NCT07112482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-08-11

No results posted yet for this study

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 \[EORTC QLQ-C30\]).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Pakistan Institute of Medical Sciences

    collaborator OTHER_GOV

  • Pakistan Society of Pediatric Oncology

    lead OTHER

Principal Investigators

  • Clinical Research Coordinator, MSPH, DrPH · Pakistan Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2025-06-30
Completion
2025-07-15

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07112482 on ClinicalTrials.gov