Trial reportCancer prevention research (Philadelphia, Pa.)2011
Randomized phase II trial of sulindac, atorvastatin, and prebiotic dietary fiber for colorectal cancer chemoprevention.
Trial report in Cancer prevention research (Philadelphia, Pa.), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
26 citing papers in PubMed, 3 syntheses or guidelines pooled it, 70 citations in OpenAlex.
- Efficacy and safety profile of statins in patients with cancer: a systematic review of randomised controlled trials.European journal of clinical pharmacology · 2020Pooled it
- Dietary fibre for the prevention of recurrent colorectal adenomas and carcinomas.The Cochrane database of systematic reviews · 2017Pooled it
- The effects of nutritional interventions on recurrence in survivors of colorectal adenomas and cancer: a systematic review of randomised controlled trials.European journal of clinical nutrition · 2016Pooled it
- Randomized Phase II Trial of Polyphenon E versus Placebo in Patients at High Risk of Recurrent Colonic Neoplasia.Cancer prevention research (Philadelphia, Pa.) · 2021Trial
- Multicenter, Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Pravastatin Added to First-Line Standard Chemotherapy in Small-Cell Lung Cancer (LUNGSTAR).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2017Trial
- Was It Worth It? Response Data from >650 US and International Participants in Chemoprevention Trials.Cancer prevention research (Philadelphia, Pa.) · 2026Article
- Anticancer potential of dietary fiber for colorectal carcinoma: a narrative review.Annals of medicine · 2025Review
- Molecular and Immunomodulatory Mechanisms of Statins in Inflammation and Cancer Therapeutics with Emphasis on the NF-κB, NLRP3 Inflammasome, and Cytokine Regulatory Axes.International journal of molecular sciences · 2025Review
- Oxidized Low-Density Lipoprotein as a Potential Target for Enhancing Immune Checkpoint Inhibitor Therapy in Microsatellite-Stable Colorectal Cancer.Antioxidants (Basel, Switzerland) · 2025Review
- Prebiotics and Probiotics for Gastrointestinal Disorders.Nutrients · 2024Review
- Inulin-based formulations as an emerging therapeutic strategy for cancer: A comprehensive review.International journal of biological macromolecules · 2024Review
- Colorectal cancer and inulin supplementation: the good, the bad, and the unhelpful.Gastroenterology report · 2024Review
- Inulin impacts tumorigenesis promotion by colibactin-producingFrontiers in microbiology · 2023Article
- Radiotherapy and the gut microbiome: facts and fiction.Radiation oncology (London, England) · 2021Review
- Modulation of Gut Microbiota to Enhance Effect of Checkpoint Inhibitor Immunotherapy.Frontiers in immunology · 2021Review
- Dysplastic Aberrant Crypt Foci: Biomarkers of Early Colorectal Neoplasia and Response to Preventive Intervention.Cancer prevention research (Philadelphia, Pa.) · 2020Review
- Chemoprevention of Colorectal Cancer by Dietary Compounds.International journal of molecular sciences · 2018Review
- Article
- Intestinal microbiota: a novel perspective in colorectal cancer biotherapeutics.OncoTargets and therapy · 2018Review
- Association between factors associated with colorectal cancer and rectal aberrant crypt foci in humans.Oncology letters · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 5 institutions in 1 country.
Funding
Abstract
Sulindac, atorvastatin, or prebiotic dietary fiber may reduce colorectal cancer (CRC) risk. However, clinical trial data are currently limited. We conducted a randomized, phase II chemoprevention trial involving subjects 40 years or older, with previously resected colon cancer or multiple/advanced colorectal adenomas. Magnification chromoendoscopy (MCE) was performed to identify and characterize rectal aberrant crypt foci (ACF); eligibility criteria required five or more rectal ACFs at baseline. Intervention assignments were as follows: (a) atorvastatin 20 mg qd; (b) sulindac 150 mg bid; (c) oligofructose-enriched inulin (as ORAFTI®Synergy1) 6 gm bid; or (d) control (maltodextrin) 6 gm bid, for 6 months. Percent change in rectal ACF number (%ΔACF) within arm was the primary endpoint. Secondary endpoints included changes in proliferation (Ki67) and apoptosis (caspase-3), as measured from normal mucosa biopsy samples. Among 85 eligible randomized subjects, 76 (86%) completed the trial per protocol. The median (range) of rectal ACF was 9 (5-34) and 8 (0-37) at baseline and postintervention, respectively. The median (SD) for %ΔACF was 5.6 (-69% to 143%), -18.6 (-83% to 160%), -3.6 (-88% to 83%), and -10.0 (-100% to 117%) in the atorvastatin, sulindac, ORAFTI®Synergy1 and control arms, respectively. Neither within-arm (P = 0.12-0.59) nor between-arm (P = 0.30-0.92) comparisons of %ΔACF were statistically significant. The active and control interventions also seemed to have similar effects on mucosal proliferation and apoptosis (P > 0.05 for each comparison). Data from this multicenter, phase II trial do not provide convincing evidence of CRC risk reduction from 6-month interventions with atorvastatin, sulindac, or ORAFTI®Synergy1, although statistical power was limited by the relatively small sample size.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.