Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cachexia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring
- description
- 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.
- interventionNames
- Behavioral: Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring
- type
- ACTIVE_COMPARATOR
- label
- Standard Oncological Care
- description
- Participants in this group will receive standard oncological care only, including chemotherapy and other routine cancer treatments, without additional dietary or psychosocial interventions.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available