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

NCT ID: NCT07112482

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2025-07-15

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]).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring

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.

Group Type: EXPERIMENTAL

Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Female patients aged 20 to 60 years

2. Histologically confirmed advanced breast cancer

3. Documented unintentional weight loss of ≥5% over the past 6 months

4. Hemoglobin level <12 g/dL or average daily energy intake <1500 kcal/day

5. Ability to provide written and verbal informed consent

Exclusion Criteria

1. Malnutrition due to non-cancer causes (e.g., chronic starvation, eating disorders)

2. Presence of chronic gastrointestinal or endocrine disorders affecting nutritional status (e.g., Crohn's disease, Cushing's syndrome)

3. Current pregnancy or lactation

4. Concurrent diagnosis of another malignancy

5. Any condition that, in the opinion of the investigator, may interfere with study participation or outcomes (e.g., severe psychiatric illness, cognitive impairment)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pakistan Institute of Medical Sciences

OTHER_GOV

Sponsor Role: collaborator

Pakistan Society of Pediatric Oncology

OTHER

Sponsor Role: lead

Responsible Party

Junaid Jamshed

Clinical Research Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clinical Research Coordinator, MSPH, DrPH

Role: STUDY_CHAIR

Pakistan Institute of Medical Sciences

Locations

Fauji Foundation Hospital

Rawalpindi, , Pakistan

Countries

Pakistan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

794/RC/FFH/RWP

Identifier Type: -

Identifier Source: org_study_id