{"entity":{"id":"whel","kind":"trial","name":"WHEL (Women's Healthy Eating and Living)","aka":[],"tldr":"Three thousand breast cancer survivors were coached for years to eat far more vegetables, fruit and fibre. They did, and it made no difference to recurrence or survival.","summary":"WHEL randomised 3,088 women (1995-2000) and followed them for a mean 7.3 years. The intervention group substantially and durably changed their diet (vegetables +65%, fruit +25%, fibre +30%, fat -13% at four years, confirmed by plasma carotenoids). Invasive breast cancer events (16.7% vs 16.9%) and deaths (10.1% vs 10.3%) did not differ. Secondary analyses generated hypotheses later explored elsewhere: women with both high vegetable-fruit intake and high physical activity had lower mortality; a nightly fast under 13 hours was associated with recurrence. WHEL and WINS (low-fat diet, marginal effect confined to HR-negative disease) are the reason the field moved from diet alone to energy balance, weight loss and exercise, and they are a standing caution against assuming observational diet associations are causal.","status":"negative","asOf":"2026-09-08","links":[{"label":"ClinicalTrials.gov NCT00003787","url":"https://clinicaltrials.gov/study/NCT00003787"},{"label":"Pierce et al. (JAMA 2007)","url":"https://doi.org/10.1001/jama.298.3.289"}],"tags":[],"related":[],"cancers":["breast-hr-positive","tnbc"],"sections":["nutrition-lifestyle"],"technologies":["mediterranean-plant-forward-diet","dietitian-led-weight-loss-breast","time-restricted-eating"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["dietary-pattern-scores","energy-balance"],"trials":[],"people":[],"bottlenecks":["b-negative-results","b-survivorship"],"keyPapers":["paper-whel-jama-2007"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00003787","phase":"3","setting":"Early-stage breast cancer survivors within 4 years of diagnosis: intensive telephone counselling for a diet very high in vegetables, fruit and fibre and low in fat vs printed dietary guidelines","sponsor":"University of California San Diego / NCI","result":"Breast cancer events 16.7% vs 16.9%; no effect on recurrence or mortality despite large dietary change.","started":"1995-03","yearReported":2007,"enrolled":3088,"enrolledBasis":"registry","outcomes":[{"endpoint":"Invasive breast cancer event (recurrence or new primary)","primary":true,"unit":"%","arms":[{"name":"Dietary intervention","n":1537,"value":16.7},{"name":"Comparison","n":1551,"value":16.9}],"hr":0.96,"ci":[0.8,1.14],"source":"https://doi.org/10.1001/jama.298.3.289"}],"replication":"WINS (2,437 women, low-fat diet) showed a marginal reduction in relapse driven by weight loss and HR-negative disease; no diet-only trial has shown a recurrence benefit in breast cancer."},"route":"/trials/whel/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"section":[{"id":"nutrition-lifestyle","kind":"section","name":"Diet, Exercise & Lifestyle","route":"/fronts/nutrition-lifestyle/"}],"technology":[{"id":"dietitian-led-weight-loss-breast","kind":"technology","name":"Dietitian-led weight-loss programmes in HR-positive breast cancer","route":"/technologies/dietitian-led-weight-loss-breast/"},{"id":"mediterranean-plant-forward-diet","kind":"technology","name":"Mediterranean and plant-forward dietary patterns","route":"/technologies/mediterranean-plant-forward-diet/"},{"id":"time-restricted-eating","kind":"technology","name":"Time-restricted eating in cancer prevention and survivorship","route":"/technologies/time-restricted-eating/"}],"term":[{"id":"dietary-pattern-scores","kind":"term","name":"Dietary pattern scores (Mediterranean, HEI, AHEI, DASH, WCRF/AICR)","route":"/terms/dietary-pattern-scores/"},{"id":"energy-balance","kind":"term","name":"Energy balance","route":"/terms/energy-balance/"}],"bottleneck":[{"id":"b-negative-results","kind":"bottleneck","name":"Failures are hidden","route":"/bottlenecks/b-negative-results/"},{"id":"b-survivorship","kind":"bottleneck","name":"Survivorship and late effects are neglected","route":"/bottlenecks/b-survivorship/"}],"paper":[{"id":"paper-whel-jama-2007","kind":"paper","name":"Influence of a diet very high in vegetables, fruit, and fiber and low in fat on prognosis following treatment for breast cancer: the Women's Healthy Eating and Living (WHEL) randomized trial","route":"/key-papers/paper-whel-jama-2007/"}],"roadmap":[{"id":"nutrition-lifestyle-roadmap","kind":"roadmap","name":"Diet, exercise and lifestyle roadmap: causes established → interventions that disappointed → exercise proven as treatment","route":"/roadmaps/nutrition-lifestyle-roadmap/"}]}}