Table 2.
Characteristics of the included randomised controlled trials (n = 14) examining the association between dietary interventions and prognosis in cancer survivors.
| Author, Year | Country | Population (Clinical Features, Sample Size, Age, Follow-Up) | Intervention Description | Outcome (Primary, Secondary) | QoL Assessment | Results: Effect Parameter (CI or p-Value) | Observations |
|---|---|---|---|---|---|---|---|
| Several cancers | |||||||
| Yun, 2017 | South Korea | Cancer survivors who had completed primary cancer treatment within the last 18–24 months. 248 participants randomised: 88 allocated to usual care, 166 to intervention. | LEACH program: first 1-h health education workshop (physical activity, dietary habits, and distress management) and a 3-h leadership workshop. Next individual coaching by telephone for a 24-week period; overall 16 sessions of tele-coaching were conducted: 30 min per week for 12 sessions, 30 min per 2 weeks for 2 sessions and 30 min per month for 2 sessions. Total duration: 1 year. | Primary: changes in physical activity, diet and in PTGI. Secondary: quality of life (QoL). | HADS, EORTC QLQ-C30. | Assessment at 12-month, adjusted means intervention group vs. control group (p-value): PTGI: 66.3 vs. 61.2 (p = 0.065). HADS: 5.2 vs. 5.7 (p = 0.23). EORTC (global health): 69.0 vs. 66.0 (p = 0.27). EORTC (fatigue): 34.8 vs. 41.9 (p = 0.01). | Included in situ, localised or regional with a favourable prognosis of cancers of the breast, stomach, colon and lung. The assessment at 12-months was carried out over 72 subjects (control group) and 134 (intervention group). |
| Breast cancer (BC) | |||||||
| Scott, 2013 | UK | 90 women with early stage cancer (stage I–III), treated within the previous 3–18 months; mean age 56 years. 47 intervention, 43 controls; completed assessment at 6-month: 41 and 48. | 6-month lifestyle intervention: exercise + hypocaloric healthy eating program: 3 supervised exercise sessions/week and individualised dietary advice + weekly nutrition seminars. Diet sessions: information on portion sizes from common foods and healthy eating plan. Goal: to reduce 600 kcal of daily calorie intake of their calculated energy requirements. | Primary: body weight, body composition. Secondary: quality of life (QoL). | FACT-B assessed at baseline and at 6-month. | FACT-B QoL: significant improvement in the intervention group: >6 points (p = 0.004) in FACT-B score and >2 points (p = 0.007) in the breast cancer subscale. Moreover, reduction in the intervention group of waist circumference (p < 0.001) and waist-to-hip ratio (p < 0.005). | |
| Goodwin, 2014 | USA and Canada | LISA Study. Multicentre randomised trial in postmenopausal women with tumours stage T1-3N0-3M0, BMI ≥ 24. Lifestyle intervention (up to 24 mo) diet + physical activity counselling, evaluating secondary outcomes. Groups: (n = 167) mail-based intervention and (n = 171) individual lifestyle intervention (LI). | Both arms received information on healthy lifestyle at baseline and at 1-year. Individualised LI: 2-year telephone-based intervention on the diabetes prevention program. Goal: 10% weight loss to a BMI not less than 21; calorie reduction to attain 500–1000 kcal daily deficit, and reduction in fat to 20% of kcal, and increased intake of fruits, vegetables, and grains; gradual increase in moderate-intensity aerobic physical activity to 150–200 min/week. | Primary: disease-free survival. Secondary: overall survival, distant-disease-free survival, weight loss, quality of life (QoL). | QoL: EORTC QLQ-C30 (physical condition and overall QoL score); SF-36 (PCS and MCS); Fatigue Symptom Inventory; Breast Symptom Checklist. | Weight: mean weight loss was significantly (p < 0.001) greater in the LI arm vs. comparison arm: 5.3% vs. 0.7% at 6 months, 3.6% vs. 0.4% at 24 months. QoL: mean change in SFS6-PCS from baseline, LI arm vs. comparison arm: 4.2 vs. 2.3 at 6 months, 4.4 vs. 2.9 at 12 months, 4.1 vs. 4.4 at 24 months; p = 0.005. No significant changes in SF36-MCS. EORTC QLQ-C30 physical condition score (p < 0.001). No significant improvement in EORTC QLQ-C30 Quality of Life Score (p = 0.062). All p-values are adjusted for time period of assessment. | Accrual was terminated at 338 of 2150 planned patients because of loss of funding. Therefore, only intermediate (24-month) secondary outcomes are presented. |
| Swisher, 2015 | USA | Survivors triple-negative BC (stage I–III), BMI > 25, age < 80 years, average time at enrolment in the study after diagnosis 4–5 years. 28 women enrolled: 20 allocated to control group, 18 to the intervention. | Moderate-intensity aerobic exercise (150 min per week, for 12 weeks) and diet counselling, compared to usual care. Dietary counselling based on 2 individual sessions with the study dietitian; goal: to decrease dietary fat intake by 200 kcal per week. | Primary outcome: weight loss. Secondary: physical function, quality of life (QoL). | FACT-B. | Weight: subject in the intervention lost more body fat (2.4% loss vs. 0.4% gain, p < 0.05) than the control group. QoL (FACT-B): improvements in physical well-being (p < 0.05) and BC-specific items (p < 0.05). | Assessment based upon women who completed the trial (12 weeks): 18 in the intervention group and 10 from the control group. |
| Demark-Wahnefried, 2015 | USA | The ENERGY trial: single-blinded randomised phase 3 trial. Participants: women diagnosed within the previous 5 years on cancer stage-I-III, aged > 21 years and BMI 25–45. Intensive intervention (n = 344) or less intensive intervention (control arm) (n = 348). | Intervention: group-based, semi-structured weight loss program + telephone counselling and tailored newsletters, according to ACS guidelines. 4 months, 1 h group session/week + 1 session/week for 2 months and 1 session/week during 6–12 months + personalised guidance in between the sessions. + mailed newsletter on a quarterly basis from 6–24 months (individually tailored). Control group received two contacts: at baseline and at 6 months. | Primary outcome: quality of life (QoL). | SF-36; refined Impact of Cancer Scale (IOCv2); BCPT Symptom Scales; CES-D. | Assessment at 12 and 24-month. Non-significant changes for SF36 vitality subscale score (p-values 0.509 and 0.185). Improvement (p = 0.051) of SF-36 physical function at 12 months and no significant change at 24 months (p = 0.185); Greater positive impact of cancer (p = 0.046) at 12 months. Depressive symptoms (CES-D) increased at 24 moths (p = 0.03). | The SF36 only included specific scales for vitality and physical functioning; the IOCv2 measures impact of cancer on QoL; the BCPT Symptom Scales measures side effects of medical interventions; the CES-D measures depressive symptoms. Unexpected findings related to depressive symptoms. |
| Kwiatkowski, 2017 | France | PACThe trial. Patients enrolled within 9 months after chemotherapy or radiotherapy completion. 251 participants randomised: 117 intervention, 115 control group. | 2-week intervention in hydrothermal centres including APANE (adapted physical activity and nutritional education). Energy intake: 1200 kcal/day. Diet program based on Four-Group Point Method. Control group: individual standard recommendations at home. | Primary outcome: long-term (6-month to 5-years) quality of life. | SF36 (global score). | Effect-sizes (difference between means of the two groups divided by the common standard deviation) for the SF36 score at different time periods: 6 months 0.63 (0.37, 0.89); 1 year 0.29 (0.03, 0.55); 2 years 0.27 (−0.01, 0.56). Effect-size over the whole follow-up period 0.33 (0.23, 0.43), p < 0.01. | Secondary endpoints: anxiety/depression (HAD), sleep (adapted from Leeds sleep evaluation questionnaire), physical/sedentary activity scores. |
| Zick, 2017 | USA | Pilot study, 30 breast cancer patients stage 0-IIIa (15 intervention, 15 control group) | FRD: rich in fruits, vegetables, whole grains, and omega-3 fatty acid-rich foods. 3-months, phone counselling. Control: 8 sessions general health topics excluding diet). | Primary outcome: fatigue. Secondary: sleep quality. | BFI, PSQI | Adjusted means (difference between baseline and 3-months). BFI decreased by 2.4 in the FRD group vs. controls (p = 0.01). PSQI score decreased by 2.5 t in FRD group and increased by 0.9 in the control group (p = 0.03). | Intention-to-treat (ITT) analysis. Dietary assessment: at baseline and 3 months by means of day food records and 24-h recalls. |
| Chlebowski, 2020 | USA | WHI-DM trial. 3374 breast cancer survivors (1299 intervention, 2075 controls) median follow-up 19.6-year. | Low-fat dietary pattern: the goals were to reduce fat intake to 20% of energy and increase vegetable, fruit, and grain intake. Intervention period: 8.5-years. | Overall mortality, breast cancer specific mortality. | - | Mortality: HR 0.85 (0.74–0.96), p = 0.01. Breast cancer mortality: HR 0.79 (0.64–0.97), p = 0.02. | Intention-to-treat, secondary analysis (the primary outcome was recurrence). Lack of breast cancer therapy information. |
| Ruiz-Vozmediano, 2020 | Spain | 72 women stage IIA-IIB with treatment completed within previous 12 months. Randomised to intervention (n = 36) and control group (n = 36), completion of treatment 12 mo earlier. Follow-up: 6 month after intervention. | Intervention (6-month); diet: three 5-h workshops on healthy eating patterns and information on risk factors and prevention; exercise: 7-week period, 60-min class, 3/week, and mindfulness program (4-week, 2/week, 90 min. Control group: usual care. | Primary outcome: quality of life (QoL). Secondary outcome: change in weight. | EORTC QLQ-C30, 5 functional domains: physical, role, cognitive, emotional, and social. | Comparison of means (intervention vs. control at 6-month: significant improvements in physical functioning (p = 0.027), role functioning (p = 0.028), dyspnoea symptoms (p = 0.066). No significant changes in global health and fatigue. | only 15 patients completed at least 75% of program sessions. |
| Colorectal cancer (CRC) | |||||||
| Bourke, 2011 | UK | Pilot trial; 18 colon cancer survivors, mean age 69 years, Dukes stage A-C, recruited months post-surgery; 9 intervention, 9 controls. | Intervention: 12-week program of home-based exercise sessions and dietary advice (n = 9); controls: standard care. | Exercise and dietary behaviours, fatigue and quality of life (QoL). | FACT-F (fatigue) and FACT-C (CRC-specific QoL). | Intervention vs. control: improved fatigue (FACT-F score) p = 0.005 and no change in QoL (FACT-C score) p = 0.80. | |
| Bonelli, 2013 | Italy | Double-blind, phase III, randomised, placebo-controlled trial. 411 post-polypectomy (within 6 months from enrolment). 200 intervention, 211 placebo group. Median follow-up 4 years. | Active compound (200 μg selenium, 30 mg zinc, 2 mg vitamin A, 180 mg vitamin C, 30 mg vitamin E) vs. placebo; daily, 5 years. | Primary: recurrent adenomas or incident colorectal cancer. Secondary: advanced adenoma. | - | Recurrent adenomas (intervention vs. placebo): HR = 0.61 (0.41–0.92); for small tubular adenomas HR = 0.61 (0.37–0.99); advanced adenomas HR = 0.50 (0.24–1.01). | Intention-to-treat analysis in 330 (out of 411) participants with follow-up colonoscopy (164 intervention and 166 placebo group). |
| Ho, 2020 | China | 223 colorectal cancer survivors (82 women), mean age 65 years. 4 groups: Group A (Diet + PA), Group B (Diet only), Group C (PA only), Group D (control group). | Intervention: ‘Moving Bright, Eating Smart’. Reduce red/processed meat to <5 servings/week (<2 servings of processed meat) and to limit refined grains to 2 servings/day. Overall 12-month, with decreasing frequency on contacts along the year. Control: usual care. | Quality of life (QoL); assessment at 6, 12, 18, and 24 months. | SF-12 (health-related QoL), SF-6D utility index, FACT-C (CRC-health related QoL), FACT-G (excluding disease-specific items), HADS (anxiety and depression). | Mean difference between groups, dietary intervention vs. not receiving diet intervention: At 12-mont, SF-6D utility index scores 0.042 (0.003–0.081) and FACT-G total score 3.09 (0.13–6.04). At 24-month, SF-12 PCS scores (2.57 (0.69–4.45) and the FACT-G total scores 3.14 (0.23–6.04). Overall, reduction in HADS-depression 0.71 (1.28–0.14). | Intention-to-treat principle. Results on physical activity intervention available, but no results on combined intervention. |
| Prostate cancer | |||||||
| Parsons, 2020 | US | Men’s Eating and Living (MEAL) study, 478 men, 50–80 years, with biopsy-proven prostate adenocarcinoma early-stage (cT2a or less and PSA < 10 ng/mL). Intervention (n = 237), controls (n = 241). | MEAL intervention: counselling behavioural intervention by telephone promoting consumption of 7 or more vegetable servings daily; duration 24 months. Control group: written information about diet and prostate cancer. | Primary: time to progression (by biopsy and PSA changes). Secondary: health related quality of life (QoL). | Several functional and health prostate cancer- related QoL scores. | No significant difference in time to progression (intervention vs. control: adjusted HR 0.97 (0.76–1.25), p = 0.84. | Results on QoL no reported. |
| Endometrial cancer | |||||||
| Koutoukidis, 2019 | UK | DEUS pilot trial: parallel, randomised, controlled pilot trial; 54 survivors stage I-IVA endometrial cancer; allocation to either intervention (n = 26) or usual care (n = 28). | Intervention: the ‘Shape-Up following cancer treatment’; 8 weeks, group-based weekly 1.5 h sessions on healthy eating and physical activity based on Social Cognitive Theory and Control Theory. Control group: usual care. | Diet, physical activity, body composition, and health-related quality of life (QoL) | EORTC Core 30 and Endometrial Cancer Module (QLQ-EN24) | Change (mean) from baseline to 8 weeks: EORTC QLQ-C30, 5.0 (−3.4–13.3), p = 0.24; at 24 weeks 8.9 (0.9–16.8), p = 0.029. | Intention-to-treat analysis in participants with complete data at 24 weeks (24 intervention, 25 controls) |
Abbreviations: BMI, body mass index, PACThe, programme of Accompanying women after breast Cancer treatment completion in Thermal resorts; WHI-DM, Women’s Health Initiative—Dietary Modification; LEACH, Leadership and Coaching for Health program; LISA, Lifestyle Intervention in Adjuvant Treatment of Early Breast Cancer Study; HADS, Hospital Anxiety and Depression scale; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; SF36, Short Form Health Survey; Physical component scale (PCS) and Mental Component Scale (MCS); FACT-B, Function After Cancer Therapy-Breast; FACT-C, Function After Cancer Therapy-Colorectal; FACT-G, Function After Cancer Therapy- excluding the colorectal cancer-specific items; BCPT, Breast Cancer Prevention Trial; BFI, Brief fatigue inventory; PSQI, Pittsburgh sleep quality index; PTGI, post-traumatic growth inventory; PA, physical activity; mo, months; FRD, fatigue reduction diet; APANE, adapted physical activity and nutritional education.