Table 4.
Randomized Controlled Trials | |||||
Study | Intervention Type | Description of Intervention | Length of Intervention | Intervention Adherence |
Completion
Rate |
Samuel, 2019 [22] | Exercise | Intervention: Brisk walking for 15–20 min and resistance training for major muscles of upper and lower limb, 2 sets and 8−15 repetitions. Exercise sessions monitored at the hospital, five days a week followed by a monitored home-based program. Control: Physical exercise recommendation, 10 min walks during the day five days a week. |
Seven weeks during RT at the hospital followed by four weeks at home | NA | 120/148 Lost: Intervention 16 Control 12 |
Samuel, 2013 [30] | Exercise | Intervention: Brisk walking for 15−20 min at perceived exertion rate between 3−5/10, five days a week. Individually tailored program for major muscle groups of upper and lower limbs 2−3 sets and 8−10 repetitions. Exercise sessions five days a week. Control: No scheduled exercise sessions but advised to remain as physically active as possible. | Intervention during RT, 6 weeks | NA | 43/48 Lost: Intervention 4 Control 1 |
Cereda, 2018 [23] | Nutrition | Intervention: Nutritional counseling based on estimated protein−calorie requirement (1.2 g/kg of actual body weight), personal eating patterns and preferences, chewing and swallowing abilities. Addition of 1−2 bottles/day of n−3 polyunsaturated fatty acids−enriched ONS. Follow−up during RT: once a week for 6 weeks. After RT: one month and three months Control: Nutritional counseling as described above. No n−3 ONS but for ethical reasons ONS were prescribed when food intake was too low (< 60% of estimated requirements for two consecutive weeks). EN or PN was started if intake was too low for two consecutive weeks despite the use of ONS. |
During RT and 3 months follow−up | NA, but protein intake (g protein/kg/day) described: End of RT: Intervention 1.0 vs. control 0.87 1 month after RT: Intervention 1.16 vs. control 0.97 3 months after RT: Intervention 1.12 vs. control 0.96 |
112/159 Lost: Intervention 22 Control 25 |
Jiang, 2018 [26] | Nutrition | Intervention: ONS 100g/day (402 kcal, 18 g protein) Control: No ONS General dietary advices in both groups every week PN with glucose if intake was severely compromised |
During CRT | Consumed 52.1 g (29.4g)/day | 91/100 Lost: Intervention 5 Control 4 |
Roussel, 2017 [29] | Nutrition | Intervention: Six individualized counselling meetings with a dietitian at home (two during RT and four at the end of RT). One meeting 2 months after end of RT. Energy and protein requirements individually evaluated and nutritional adjustments obtained with regular foods, ONS or EN if necessary. Education for self−monitoring weight, adapting intake and modifying food textures. Control: As described above but only two outpatient consultations with a dietitian during RT. Recalls if needed. |
During RT, 3 months follow−up |
NA but energy intake (kcal/kg/day) described: 1 month after RT: Intervention 34 vs. control 33 3 months after RT: Intervention 35 vs. control 31 |
87/117 Lost: Intervention 16 Control 14 |
Ravasco, 2005 [27] | Nutrition | Group 1 (n = 25): individualized counselling with regular foods Group 2 (n = 25): usual diet plus ONS (2 × 200 mL containing 20 g protein and 200 kcal per day) Group 3 (n = 25): intake ad libitum Nutritional goal for group 1 and 2 was achievement of individually calculated energy and protein requirements |
Intervention during RT, 3 months follow−up | NA, but nutritional intake was primary endpoint and reported Baseline: intake similar in all groups End of RT: group 1 increase of 521 kcal/day, p = 0.002 ONS increase of 322 kcal/day, p = 0.05 Ad lib decrease of 400 kcal/day, p ≤ 0.01 Between−group finding, p = 0.005 3 months: group 1 maintained energy intake, other groups decreased, p = 0.001 |
All completed |
Isenring, 2003 [25] | Nutrition | Intervention: Individualized counselling by using a standard protocol (American Dietetic Association Medical Nutrition Therapy Head and Neck). ONS were provided when appropriate Control: Regular care, general advice by the nursing staff with samples of ONS if felt necessary. |
Intervention during RT, 3 months follow−up | NA | 32/36 Lost: Intervention 1 Control 3 |
Hearne, 1985 [24] |
Nutrition | Intervention: Intensive nasogastric feeding during RT Control: Oral intake and dietary counselling Goal for intervention in both groups: 40 kcal/kg per day and 1g protein/kg per day |
Intervention during RT, 1 month follow−up | Intervention: Two of 14 (14%) refused tube feeding and converted to control Control: Two of 12 (16%) converted to intervention due to weight loss Energy intake during RT (kcal/kg): Intervention 35−42 vs. control 15−34 No p−values given. |
26/31 Lost: Intervention 4 Control 1 |
Daly, 1984 [21] | Nutrition | Intervention: EN Control: Oral intake and dietary counselling Goal in both groups: 40 kcal/kg per day and 1−1.5 g protein/kg per day. If weight gain did not occur after each week +5 kcal/kg per day. Both groups received enteral support throughout RT (approximately 8 weeks) and for several additional weeks until reaction to radiation subsided |
Intervention during and up to 6 months follow−up | Intervention: Two of 22 (9%) converted to control due to non−compliance during the first week of RT Control: Two of 15 (11%) converted to tube feeding due to weight loss during the two first weeks of RT Energy intake (kcal/kg): Tube fed 39 vs. orally 30, p < 0.00 |
35/38 Lost: NA |
Pilot and Feasibility Studies | |||||
Study | Intervention Type | Description of Intervention | Length of Intervention | Intervention Adherence |
Completion
Rate |
Sandmæl, 2017 [9] | Exercise and nutrition | Group 1: During treatment: Resistance exercises: 2 lower body− and 2 upper body, 3−4 sets, 6 to 12 repetitions, monitored by a physiotherapist at the hospital twice a week á 30 min (total 12 sessions). Recommended 150 min of moderate intensity exercise per week in addition. After the training sessions one bottle ONS. Recommended to take 1−2 ONS each day. Group 2: During treatment: Recommended to follow physical exercise guidelines for cancer patients. 2−4 weeks after end of RT: 3 weeks stay at rehabilitation centre. Resistance exercises: 3 sessions of 45 min of involving 3 upper body and 3 lower body exercises. 3−4 sets and 6 to 12 repetitions plus two voluntary sessions each week involving a combination of strength, aerobic and balance exercises with low intensity. Dietary counselling once a week in small groups and use of ONS. |
Intervention during RT for group 1 and intervention after RT for group 2 Intervention initiated during the first week of radiotherapy lasting 6 weeks. | Adherence rates (%): Interv during RT, exercise 81 and ONS 57 After RT, exercise 94 and ONS 76 |
29/41 Lost: Intervention 2 Control 10 |
Zhao, 2016 [31] | Exercise and nutrition | Group 1: Intervention based on guidelines for patients with cancer (American College of Sports Medicine); strengthening, cardiovascular fitness and physical exercise. Exercise during the 7 weeks CRT at a clinical research center supervised by a trainer. Up to 3 sessions per week, lasting up to 1 h including warmup, cool down, and rest periods. Resistance exercises included chest press, wall push up, military press, side arm raises, biceps curl, shoulder shrugs, and calf raises. Duration and intensity were customized to the individual, goal three 8 to 12 repetition sets. Aerobic exercise was defined as walking with a pedometer and a goal to maintain step count based on the mean step count of the previous training week. Post CRT (weeks 8 to 14), integration of exercise activities into own lifestyle. Weekly telephone calls from the trainer. Before CRT counselling by a dietician, repeated in case of decrease in BMI greater than a 5% to 10%. Group 2: Standard treatment, dietary counselling and active nutritional surveillance during RT, neither encouraged nor discouraged to exercise. |
Intervention for 7 weeks 7 weeks follow up |
Exercise adherence rate 72%, Completed 15.2 of 21 sessions. |
17/20 Lost: Intervention 1 Control 2 |
Rogers, 2013 [28] | Exercise and nutrition | Group 1: Nutritional counseling and 12 weeks resistance exercise. Exercise during treatment; one hour supervised sessions twice weekly at a training facility at the hospital. Six weeks of twice weekly home−based sessions supported with telephone counseling, written materials, and DVD. Up to 10 repetitions of 9 different exercises using a resistance band for major muscle groups (chest press, leg extension, lateral row, reverse curl, triceps using wall push−up/triceps kickback, heel raise, 2−arm front raise, hamstring curl, and arm curl). Intensity: light, moderate and heavy resistance bands were used. Group 2: Nutritional counseling provided by registered dietitian according to standard counseling appropriate for head and neck cancer during radiotherapy |
12 weeks intervention | Exercise adherence: 6 weeks: 83% 6−12 weeks: 62% Both groups Face to face nutritional counselling (6 weeks): 96% completed Telephone counselling (6−12 weeks): 77% completed |
13/15 Lost: Intervention 2 Control 0 |
Capozzi, 2016 [10] | Lifestyle interventions including exercise and nutrition |
Group 1: 12 weeks lifestyle intervention during RT and Group 2: same intervention immediately after completion of RT. Components of intervention: physician referral and clinical support; health education; behavioral change support; individual exercise program (home exercises twice a week); group−based exercise (2 exercise sessions weekly) Exercise program: progressive resistance training with 2 sets of 8 repetitions at 8 to 10 repetitions maximum for 10 exercises targeting major muscle groups. In addition to exercise sessions participants were required to attend 6 education sessions biweekly |
Immediate intervention during RT for group 1 and delayed intervention after RT for group 2 Total 24 weeks |
NA | 36/60 Lost: Group1: 15 Group 2: 9 |
Abbreviations: NA: not available; RT: radiotherapy; ONS; oral nutritional supplements; EN: enteral nutrition; PN: parenteral nutrition; CRT: chemo/radiotherapy; RCT: randomized clinical trial.