CRS SUCCESS Palliative Care Nutritional Supplementation Targeted Evaluation Final Report

1. Introduction

The CRS SUCCESS (Comprehensive Restorative Support Systematic Evaluation of Care Outcomes) project was launched to assess the impact of a targeted nutritional supplementation program for patients receiving palliative care. The primary goal was to determine whether a specially formulated supplement could improve nutritional status, functional ability, and qualityoflife indicators in a population that often experiences rapid weight loss, anorexia, and fatigue.

This final report summarises the methodology, key findings, and recommendations arising from a 12month multisite evaluation conducted across eight hospice and palliative care facilities in the United States.

2. Background and Rationale

Malnutrition is a common, yet underaddressed, problem in palliative care. Studies show that up to 70% of patients develop clinically significant weight loss during the disease trajectory, which is associated with poorer symptom control, reduced tolerance to treatment, and lower overall survival. While oral nutritional supplements (ONS) are widely used, most formulations are not tailored to the metabolic and symptom profile of palliative patients.

The CRS SUCCESS supplement was developed with the following design principles:

• Highquality protein: 20g wheyprotein isolate per 250ml serving.
• Energy dense: 250kcal per serving, with a balanced carbohydratefat ratio to minimise gastrointestinal upset.
• Micronutrient enrichment: Targeted levels of vitamin D, Bcomplex, zinc, and selenium, all of which play roles in immune and wound healing pathways.
• Symptomfocused ingredients: Added smoothmuscle relaxants (e.g., ginger extract) and antinausea agents (e.g., gingerols) to improve tolerability.
• Palatability: Flavours selected based on patient preference data (vanillacream, strawberrybanana).

The evaluation aimed to answer the question: Does the CRS SUCCESS supplement deliver measurable benefits in nutritional and functional outcomes for palliative care patients compared with standard care?

3. Study Design

3.1 Participants

In total, 462 adult patients (age18years) receiving palliative care were screened. Inclusion criteria required a Mini Nutritional Assessment (MNA) score17 (indicating risk of malnutrition) and an expected survival of at least 8weeks. Exclusion criteria were severely compromised swallowing reflexes, known allergy to supplement ingredients, and participation in another nutrition trial.

After enrolment, 401 participants were randomised 1:1 to the Intervention (CRS SUCCESS) or Control (standard ONS) arm. Baseline characteristics were balanced across groups (mean age=68years, 52% female, most common diagnoses: advanced lung, colorectal, and pancreatic cancers).

3.2 Intervention

Patients in the Intervention arm received two 250ml servings of CRS SUCCESS per day (total 500kcal, 40g protein) for the 12week study period, with continuation possible for an additional 12weeks if clinical benefit was observed. The Control arm received the facilitys usual ONS (typically a standard 200kcal, 10g protein formula) with the same frequency.

3.3 Outcomes

Primary outcome:

• Change in lean body mass (LBM) measured by bioelectrical impedance analysis (BIA) from baseline to week12.

Secondary outcomes:

• Weight change (kg).
• Patientreported appetite (visual analogue scale, 0100mm).
• Handgrip strength (kg).
• Quality of life (EORTC QLQC15PAL).
• Adverse events related to supplementation.

3.4 Data Collection & Analysis

Assessments were performed at baseline, week4, week8, week12, and at a 24week followup. Intentiontotreat (ITT) analysis was applied. Mixedeffects models accounted for repeated measures and site clustering. A pvalue<0.05 was considered statistically significant.

4. Key Findings

4.1 Primary Outcome Lean Body Mass

At week12, the Intervention group showed a mean increase of **+1.2kg** in LBM, whereas the Control group experienced a mean decrease of **0.4kg** (difference=1.6kg; 95% CI1.02.2kg; p<0.001). This effect persisted at the 24week followup, with an average betweengroup difference of **+1.4kg**.

4.2 Secondary Outcomes

• Weight: Intervention participants gained an average of **+2.0kg** (SD=1.4) versus a loss of **0.7kg** in controls (p<0.001).
• Appetite: Visual analogue scores improved by **+23mm** in the supplement arm compared with **+5mm** in controls (p=0.004).
• Handgrip strength: Mean increase of **+3.3kg** vs **+0.8kg** (p=0.012).
• Quality of life: Overall QLQC15PAL scores rose by **+9.5 points** (intervention) while declining by **2.3 points** (control) (p=0.018).
• Adverse events: Minor gastrointestinal discomfort was reported in 8% of the intervention group versus 12% in controls; no serious supplementrelated events occurred.

4.3 Subgroup Analyses

Patients with baseline serum albumin<3.2g/dL demonstrated the greatest LBM gain (+1.9kg). Conversely, those receiving concurrent chemotherapy showed a slightly attenuated response, though still statistically significant.

4.4 Economic Considerations

Costeffectiveness modelling indicated that the additional expense of CRS SUCCESS ($3.50 per 250ml serving) was offset by reduced hospital readmissions (average reduction of 0.4 admissions per patient) and lower use of parenteral nutrition, yielding an incremental costeffectiveness ratio of **$2,400 per qualityadjusted life year (QALY) gained**, comfortably below the commonly accepted $50,000 threshold.

5. Discussion

The CRS SUCCESS targeted supplementation program produced clinically meaningful improvements across all measured domains. The most striking result was the preservation and modest increase of lean body mass, which is vital for maintaining functional independence in palliative populations.

Several mechanisms likely contributed to these outcomes:

• Highquality protein: Wheyprotein isolates provide rapidly digestible essential amino acids, stimulating muscle protein synthesis even in catabolic states.
• Energy density: The caloric load helped bridge the gap between reduced intake and metabolic demands.
• Micronutrient fortification: Vitamin D and zinc support immune function, potentially reducing infectionrelated catabolism.
• Symptomfocused formulation: The inclusion of antinausea botanicals improved tolerability, leading to higher adherence (average 92% of prescribed doses).

Importantly, the supplement was welltolerated, with a safety profile comparable to standard ONS. The modest rise in minor GI complaints suggests that future formulations could further optimise fibre content to minimise this effect.

Limitations of the study include the relatively short primary evaluation period (12weeks) and the reliance on BIA for body composition, which can be influenced by fluid shifts common in advanced disease. Nevertheless, the consistency of findings across multiple objective and subjective measures strengthens confidence in the results.

6. Recommendations

1. Adopt CRS SUCCESS as standard of care for malnourished palliative patients where oral intake is compromised but safe to administer.
2. Integrate routine screening (MNA or equivalent) at admission to identify candidates early.
3. Maintain individualized dosing based on weight, disease stage, and renal/hepatic function.
4. Conduct longerterm followup studies (612months) to evaluate sustainability of benefits and impact on survival.
5. Explore combination therapy with appetite stimulants (e.g., megestrol acetate) for patients with refractory anorexia.

Implementation of these recommendations is expected to improve patient outcomes, reduce healthcare utilisation, and align with patientcentred goals of comfort and dignity.

7. Conclusion

The CRS SUCCESS palliative care nutritional supplementation programme demonstrates that a purposebuilt, energydense, proteinrich supplement can significantly reverse or attenuate malnutrition in patients facing lifelimiting illness. By improving lean body mass, functional strength, appetite, and quality of life, the supplement addresses a critical gap in supportive oncology and hospice care. The evidence supports widespread adoption and further research to refine dosing strategies and extend benefits to broader patient populations.