Colorectal Cancer
Conditions
Keywords
Anthocyanins, colorectal cancer, systemic inflammation, inflammatory biomarkers, C-reactive protein, supportive care, functional food
Brief summary
This prospective, open-label interventional study evaluated the effects of short-term supplementation with an anthocyanin-rich freeze-dried black raspberry and strawberry preparation in patients undergoing treatment for colorectal cancer. The study assessed the tolerability of the intervention and longitudinal changes in nutritional status and selected inflammatory and biochemical biomarkers. Participants received the anthocyanin-rich supplement for 21 consecutive days in addition to standard oncological treatment and were assessed at baseline and during follow-up.
Detailed description
This prospective, open-label interventional study was conducted in patients with histologically confirmed colorectal adenocarcinoma undergoing standard oncological treatment. The study aimed to evaluate the effects of short-term oral supplementation with an anthocyanin-rich preparation derived from freeze-dried black raspberry and strawberry on inflammatory response and nutritional status, as well as to assess the feasibility and tolerability of the intervention. Participants in the intervention group received a standardized anthocyanin-rich preparation providing approximately 600-700 mg of anthocyanins per day for 21 consecutive days, in addition to standard oncological treatment. The preparation was chemically characterized prior to its clinical use. Clinical and laboratory assessments were performed at baseline before initiation of the intervention and subsequently at approximately 4 and 12 weeks. Assessments included clinical evaluation, anthropometric measurements, nutritional assessment using the Mini Nutritional Assessment (MNA/MNA-SF), and collection of peripheral blood samples. Laboratory analyses included selected inflammatory and biochemical biomarkers, including C-reactive protein (CRP), interleukins and tumor necrosis factor alpha (TNF-α), as well as selected growth factors and routine biochemical parameters. The study included patients treated in a real-world oncology setting and receiving different standard treatment modalities according to clinical indications, including surgery, chemoradiotherapy, and systemic therapy. Standard oncological treatment was not modified as part of the study intervention. A concurrent group of individuals without colorectal cancer undergoing colonoscopy was included to provide baseline comparative data. This group did not receive the study supplementation and was not followed longitudinally. Longitudinal analyses therefore focused on changes over time among participants receiving the anthocyanin-rich preparation. The study was designed to characterize longitudinal changes in inflammatory and nutritional parameters during colorectal cancer treatment and to evaluate the feasibility and tolerability of short-term anthocyanin-rich berry supplementation in this clinical setting.
Interventions
DIETARY_SUPPLEMENTAnthocyanin-Rich Freeze-Dried Berry Supplement
Participants received a standardized oral anthocyanin-rich supplement derived from freeze-dried black raspberry and strawberry for 21 consecutive days. The supplement was administered at a dose of five tablets three times daily (15 tablets/day), providing approximately 600-700 mg of anthocyanins per day. Standard oncological treatment was continued according to clinical indications.The baseline comparator group consisted of individuals without colorectal cancer undergoing colonoscopy who did not receive anthocyanin supplementation. This group was included solely for comparison of baseline demographic, clinical, and laboratory parameters and did not participate in the longitudinal intervention phase
Sponsors
Jagiellonian University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* (1) histologically confirmed primary colorectal adenocarcinoma; (2) qualification for surgical treatment, neoadjuvant chemoradiotherapy, or systemic chemotherapy; (3) ability to receive oral supplementation; and (4) Eastern Cooperative Oncology Group (ECOG) performance status ≤2. (5)Age ≥65 years
Exclusion criteria
* (1) gastrointestinal obstruction; (2) advanced cardiac or respiratory failure; (3) severe renal or hepatic insufficiency; and (4) food allergies or hypersensitivity that could interfere with administration of the study supplement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Inflammatory Biomarkers | Baseline, Week 4, and Week 12 | Change in circulating inflammatory biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1 alpha (IL-1α), and tumor necrosis factor alpha (TNF-α), compared with baseline. |
Countries
Poland
Outcome results
None listed