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

NCT07112482 | Completed DMC

• 1 other identifier: 794/RC/FFH/RWP
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer; Cachexia

Keywords

Cancer-associated cachexia; Randomize Controlled Trail; Dietary Counselling; Nutritional Monitoring; Breast cancer

Outcome Measures

Primary Outcomes (1)

• Change in cachexia severity measured by the Mini-CASCO composite score

  The primary outcome will be the change in cachexia severity from baseline to six months, measured using Mini-CASCO, which includes: Body Composition (40%): Body weight and lean body mass assessed by digital scale and BIA. Inflammatory/Metabolic/Immune Status (20%): CRP, albumin, hemoglobin, and lymphocyte count. Physical Performance (15%): ECOG scale, handgrip strength, stair climbing, and fatigue assessments. Anorexia (15%): SNAQ scores, 24-hour recall, and food frequency questionnaires. The Mini-Cancer Cachexia Score (Mini-CASCO) is a validated multidimensional scoring system that assesses cancer cachexia severity using five domains: body composition, inflammation/metabolism, physical performance, anorexia, and quality of life. The total score ranges from 0 to 100, with higher scores indicating more severe cachexia.

  From baseline to 6 months

Secondary Outcomes (6)

• Change in Body Weight

  From baseline to 6 months

• Change in Lean Body Mass

  From baseline to 6 months

• Change in C-Reactive Protein (CRP)

  From baseline to 6 months

• Change in ECOG Performance Status

  From baseline to 6 months

• Change in SNAQ Score (Simplified Nutritional Appetite Questionnaire)

  From baseline to 6 months

Study Arms (2)

Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring

EXPERIMENTAL

Participants in the intervention group will receive: Standard oncological care (including chemotherapy and other routine cancer treatments) plus Individualized dietary counseling: Tailored nutrition plans developed by a clinical dietitian based on energy (25-30 kcal/kg/day) and protein (1.2-1.5 g/kg/day) needs, adjusted for 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: Using structured food records and goal adherence checklists. Light physical activity guidance: Encouragement to engage in low-intensity activity appropriate to patient capacity. Psychosocial support: Sessions with a certified clinical psychologist to address emotional distress, fatigue, and anorexia. Adherence criteria: Defined as attending ≥75% of sessions and meeting ≥80% of dietary goals.

Behavioral: Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring

Standard Oncological Care

ACTIVE COMPARATOR

Participants in this group will receive standard oncological care only, including chemotherapy and other routine cancer treatments, without additional dietary or psychosocial interventions.

Behavioral: Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring

Interventions

Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring BEHAVIORAL

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.

Standard Oncological Care; Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients aged 20 to 60 years
• Histologically confirmed advanced breast cancer
• Documented unintentional weight loss of ≥5% over the past 6 months
• Hemoglobin level \<12 g/dL or average daily energy intake \<1500 kcal/day
• Ability to provide written and verbal informed consent

You may not qualify if:

• Malnutrition due to non-cancer causes (e.g., chronic starvation, eating disorders)
• Presence of chronic gastrointestinal or endocrine disorders affecting nutritional status (e.g., Crohn's disease, Cushing's syndrome)
• Current pregnancy or lactation
• Concurrent diagnosis of another malignancy
• Any condition that, in the opinion of the investigator, may interfere with study participation or outcomes (e.g., severe psychiatric illness, cognitive impairment)

Sponsors & Collaborators

• Pakistan Society of Pediatric Oncology: lead
• Pakistan Institute of Medical Sciences: collaborator

Study Sites (1)

Fauji Foundation Hospital

Rawalpindi, 44000, Pakistan

Location

MeSH Terms

Conditions

Breast Neoplasms; Cachexia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Clinical Research Coordinator, MSPH, DrPH

  Pakistan Institute of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Coordinator

Model Details: The intervention group will receive standard oncological care along with tailored dietary counseling and monthly nutritional monitoring for six months. Plans will target 25-30 kcal/kg/day and 1.2-1.5 g/kg/day protein intake, adapted to clinical condition, treatment tolerance, and preferences. Counseling sessions (every 15-21 days) will last 25-30 minutes and address dietary challenges, food tolerance, and symptom-related barriers. Dietary adherence will be tracked using structured food logs and checklists. Light physical activity and psychosocial support will be encouraged. Adherence will be defined as ≥75% session attendance and ≥80% dietary goal achievement.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 8, 2025
• Study Start: August 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 15, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be available starting 6 months after publication of the primary results and will remain accessible for 3 years.
• Access Criteria: IPD will be available to researchers with a methodologically sound proposal. Requests must be submitted in writing to the principal investigator and must include a study protocol and ethical approval. Data will be provided through a secure data access system upon signing a data-sharing agreement.

Locations

PA (1)