Table 2.
| Parameter | WINS |
WHEL |
||
|---|---|---|---|---|
| Mean | SD | Mean | SD | |
| Eligibility | ||||
| Stage | I-III A | I-III A | ||
| Time from surgery, months | ≤ 12 | ≤ 48 | ||
| Chemotherapy | AC, CMF, FAC, or AC → paclitaxel | Any (before randomization) | ||
| Hormone therapy | Tamoxifen | Any | ||
| Receptor status | Any | Any | ||
| Age, years | 48-79 | 18-70 | ||
| Weight/body mass index | Any | Any | ||
| Diet at baseline | ≥ 20% calories from fat | Any | ||
| Dietary intervention | ||||
| Intervention phase | Eight individual dietitian visits over 16 weeks | 18 telephone calls over 12 months, four cooking classes (average attended) | ||
| Maintenance phase | Individual dietitian visits every 3 months | Telephone calls every 3 months | ||
| No. of patients | 2,437 | 3,088 | ||
| Random assignment type | 3:2 | 1:1 | ||
| Intervention target | ||||
| Fat | ↓ to 15% calories from fat | ↓ to < 20% calories from fat | ||
| Calories | No target | |||
| Vegetable | ↑ (no target) | ↑ to 5 serving/day and 16 oz vegetable juice/day | ||
| Fruit | ↑ (no target) | Increase to three servings/day | ||
| Body weight | NA | NA | ||
| Physical activity | NA | NA | ||
| Follow-up interval, years | 5 | 7.3 | ||
| End point | Relapse-free survival | Breast cancer event-free survival | ||
| Self monitoring | Daily keeping score book | No | ||
| Dietary assessment | Two 24-hour unannounced telephone calls/year | Four prescheduled 24-hour telephone calls at 1, 4, and 6 years | ||
| End point events, No. | 277 | 518 | ||
| Primary breast cancer outcome | HR, 0.76; 95% CI, 0.60 to 0.98; P = .034 | HR, 0.96; 95% CI, 0.80 to 1.14; P = .63 | ||
| % energy from fat | ||||
| Baseline | 29.6 | 7.1 | 28.5 | 0.18 |
| 1 year | 20.3 | 7.8 | 22.7 | 0.20 |
| 4 year | 22.6 | 8.5 | 27.1 | 0.24 |
| 6 year | 23.0 | 9.2 | 28.9 | 0.25 |
| Body weight, kg | ||||
| Baseline | 72.7 | 15.9 | 73.5 | 0.42 |
| 1 year | 70.6 | 15.2 | 73.0 | 0.45 |
| 4 year | 71.2 | 14.9 | 74.2 | 0.51 |
| 6 year | 69.4 | 13.9 | 74.1 | 0.54 |
| Fiber g/day | ||||
| Baseline | 18.4 | 4.1 | 21.1 | 0.21 |
| 1 year | 19.5 | 4.7 | 29.0 | 0.28 |
| Vegetable servings/day | ||||
| Baseline | Not reported | 3.9 | 0.06 | |
| 1 year | — | 7.8 | 0.09 | |
| Fruit servings/day | ||||
| Baseline | Not reported | 3.5 | 0.05 | |
| 1 year | — | 4.2 | 0.06 | |
Abbreviations: WINS, Women's Intervention Nutrition Study; WHEL, Women's Healthy Eating and Living Study; SD, standard deviation; AC, doxorubicin and cyclophosphamide; CMF, cyclophosphamide, methotrexate, and fluorouracil; FAC, fluorouracil, doxorubicin, and cyclophosphamide; NA, not available; HR, hazard ratio.