Introduction
Material and methods
Patients
No | Age | Sex | Primary tumor | Measurement of disease | Metastases | Therapy between primary surgery and start of diet |
---|---|---|---|---|---|---|
1 | 47 | f | Ovarian cancer | CT, CA 125 | LI, LN, PC | 10 × Taxol/Carboplatin; 10 × Hycamptin |
2 | 46 | f | Breast Cancer | PET | MPE, AS | Radiatio, 6 × [CMF]; 12 × [Epirubicin/Cyclophosphamid[, 14 × [Taxotere[, 2 × [Gemcetabine] |
3 | 48 | f | Granulosa cell tumor | CT, PET, Inhibin | LI, MI | 6 × [Carboplatin/Epirubicin/Cyclophosphamid], 3 × Hemihepatectomy |
4 | 30 | f | Parotis carcinoma | CT | LO | Multiple surgery; Radiation; 6 × [Paclitaxel/Cisplatin] |
5 | 62 | f | Ovarian Cancer | US, CA 125 | PC, FIGO IV | ? × [Taxol/Carboplatin] |
6 | 38 | f | Osteosarcoma (jaw) | CT | LO | Multiple surgery |
7 | 51 | m | Oesophagus carcinoma | CT | LI, LN, MPE | 2 × [Radiotherapy+Cisplatin/5-FU]; 2 × [Cisplatin/5-FU]; 7 × [Doxotaxel] |
8 | 65 | f | Pancreas carcinoma | MRI | LI | 6 × [Gemcetabine], Immunotherapy (Survivin) |
9 | 33 | m | Thyroid carcinoma | US, CT, Calcitonin | LI, BO | Sanostatin, Interferon |
10 | 50 | m | Pancreas carcinoma | PET | LI | CapRI-Study branch A (Radiotherapy, Cisplatin/5-FU, IFN-alpha) |
11 | 64 | f | Thyroid carcinoma | CT, TG | LU, LN | Radio-Jod Therapy, Sanostatin |
12 | 42 | f | Colon carcinoma | PET | LI, LU | 6 × Radiotherapie (38,6 GBq I-131); Avastin; ? × [Cisplatin/Carboplatin] |
13 | 54 | f | Endometrial cancer | CT | LI, PC, AS | 8 × [Cisplatin/Adriamycin]; 2 × [Adriamycin/Doxorubicin]; 6 × [Navelbine/Carboplatin] |
14 | 60 | f | Lung cancer | PET | LI | 6 × [Carboplatin/Cisplatin/Etoposid] |
15 | 62 | m | Stomach cancer | PET | LI, PE, AS | 1 × [Irinothekan/5-FU/Folinacid]; 5 × [Etoposid/5-FU/Folinacid] |
16 | 54 | f | Ovarian cancer | CA 125 | PC, AS, Figo IIIC | ? × [Taxol/Carboplatin] |
Study design
Nutrition
Rule | Description |
---|---|
1 | Avoid all types of bread, cake, processed snacks, sweets, potatoes, pasta, rice, polenta, vegetables rich in starch (corn, beans, peas) and cereals. |
2 | Be aware of hidden sources of CHO in sugar sweetened drinks, candy, chewing gum with sugar, milk and milk products, lunch meat and some cheeses as well as in most "low fat" products. |
3 | Fruits are rich in CHO, therefore always calculate the amount and select those which are low in CHO. |
4 | Vegetables are often rich in CHO - but mainly in dietary fiber, therefore calculate the usable CHO only. |
5 | If possible, prefer cold-water fish and meat from grazing cattle as protein sources, because of their preferable fatty acid pattern |
6 | Vegetables and the few fruits allowed should be grown organic |
7 | As nibbles, select oil-rich nuts (walnuts, brazil nuts, macadamia nuts) and seeds (sunflower), and only occasionally chocolate with very high cacao content (min. 85%). |
Highly fermented yoghurt-drink | Vegetable oil mixture | Protein preparation | |
---|---|---|---|
Ingredients | skimmed milk | line seed oil | milk-protein |
plant oil mixture | canola oil | ||
pectin | walnut oil | ||
MCT | |||
grape seed oil | |||
argan-oil | |||
pumpkin seed oil, | |||
Energy per 100 g | 245 kJ/59 kcal | 3730 kJ/891 kcal | 1550 kJ/370 kcal |
Protein | 1,5 g | 0 | 88-90,3 g |
Fat | 5,1 g | 99,9 g | 1 g |
Saturated FA | 1,3 g | 36,5 g | n.a. |
Unsaturated FA | 3,8 g | 63,4 | n.a. |
Omega-3 FA | 0,3 g | 19,6 g | n.a. |
CHO | 1,7 g | 0 | 0,2 g |
Evaluation
Scoring and Statistics
Results
Trial profile
Recruitment of patients
Course of the diet
No | Duration of diet (weeks) | Ketosis > 0.5 mmol/l (% of days) | Diet rating | EORTC > 2 months | Laboratory parameters evaluated for statistics | Result | Reason for drop out |
---|---|---|---|---|---|---|---|
1 | < 1 | - | - | - | ? | Drop out after 3 days because of vomiting, fatigue | |
2 | < 2 | - | + | - | ? | Drop out after 10 days because of family problems | |
3 |
12
|
61%
| +++ | yes | yes |
SD
| |
4 | 8 | - | + | yes | yes | progress | Impaired food intake |
5 |
12
| 25% | ++ | yes | yes |
SD
| |
6 | 6 |
97%
| ++ | - | yes | progress | Impaired food intake |
7 | 2 | - | o | - | - | death | |
8 | 5 | - | - | - | - | death | |
9 |
12
|
78%
| ++ | yes | yes |
SD
| |
10 | 6 | 22% | + | - | yes | progress | Very advanced stage with fatigue and eating problems |
11 |
12
| 25% | ++ | yes | yes |
SD
| |
12 | 7 | 44% | ++ | - | yes | progress | Resumption of chemotherapy |
13 | 8 |
88%
| ++ | yes | yes | progress | Massive ascites, impaired food intake |
14 | 4 | - | o | - | - | ? | Felt unable to continue the diet |
15 | 7 |
60%
| ++ | - | yes | progress | Impaired food intake |
16 |
12
|
100%
| +++ | yes | yes |
SD
|
Quality of life
Blood parameters and leukocyte count
Param.: | CRP | Glucose | HBA1c | Chol. | LDL | HDL | Triglyc. | Crea. | Urea | ALT | Alb | Leuc. | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Units | mg/dl | mg/dl | % | mg/dl | mg/dl | mg/dl | mg/dl | mg/dl | mg/dl | U/l | d/dl | N*1000/µl | ||||||||||||
Norm-range | 0-0, 5 | <120 | 130-220 | 0-150 | > = 35 | 74-172 | 0 - 0,95 | 10 - 50 | < = 35 | 3,5-5,5 | 5 - 10 | |||||||||||||
No | wk | S | S | E | S | E | S | E | S | E | S | E | S | E | S | E | S | E | S | E | S | E | S | E |
1 | < 1 | 0,77 | 109 | - | - | - | - | - | - | - | - | - | - | - | 0,6 | - | 28,6 | - | 50,4 | - | 4,3 | - | 7,0 | - |
2 | < 2 | 0,6 | 86 | - | - | - | 231 | - | 130 | - | 88 | - | 63 | - | 0,7 | - | 32,1 | - | 16,2 | - | 4,2 | - | 3,6 | - |
3 |
12
| 0,6 | 91 | 90 | 5,8 | 5,3 | 104 | 119 | 32 | 38 | 65 | 65 | 34 | 78 | 0,8 | 0,7 | 36,4 | 42,6 | 23,1 | 25,3 | 4,4 | 4,1 | 4,5 | 4,2 |
4 | 8 | 8,1 | 117 | 103 | - | 5,7 | - | 201 | - | 129 | 47 | 49 | 88 | 80 | 0,4 | 0,5 | 23,0 | 19,0 | 24,0 | 29,0 | - | - | 5,4 | 6,3 |
5 |
12
| 0,4 | 91 | 87 | 5,6 | 5,4 | 197 | 204 | 115 | 104 | 46 | 52 | 178 | - | 0,7 | 0,6 | 27,3 | 23,0 | 29,0 | 19,0 | 4,4 | 4,8 | 7,5 | 6,2 |
6 | 6 | - | 72 | - | 5,4 | - | 139 | - | 58 | - | 74 | - | 34 | - | 0,6 | 0,6 | 20,3 | 29,1 | 15,5 | 17,8 | 5,0 | 4,8 | 5,5 | 7,6 |
7 | 2 | 1,91 | 84 | - | 5,7 | - | - | - | - | - | - | - | - | 0,7 | - | 12,1 | - | 10,3 | - | 3,4 | - | 4,2 | - | |
8 | 5 | 4,0 | 101 | 89 | - | - | - | - | - | - | - | - | - | - | 0,7 | 0,7 | 26,9 | 49 | 12,4 | 16,0 | 4,0 | 3,6 | 7,3 | 11 |
9 |
12
| 1,9 | 87 | 78 | 4,7 | 4,9 | - | 79 | - | 16 | - | 26 | - | 185 | 0,7 | 0,8 | 27,0 | 31,2 | 58,0 | 56,6 | 4,8 | 4,0 | 2,9 | 3,1 |
10 | 6 | - | 168 | 79 | 5,3 | - | 190 | 193 | 124 | 117 | 52 | 40 | 71 | 179 | 0,8 | 1 | 40,9 | 35,4 | 90,2 | - | 4,2 | - | 7,4 | 8,5 |
11 |
12
| 0,18 | 112 | 94 | 5,4 | - | 221 | 178 | 117 | 81 | 85 | 80 | 97 | 84 | 0,8 | 0,6 | 30 | 26 | 15,7 | 15,7 | 4,3 | 4,4 | 5,2 | 5,8 |
12 | 7 | - | 94 | 95 | 4,7 | - | - | - | 146 | 152 | - | - | - | - | 0,6 | 0,6 | - | - | 46 | 29 | - | 3,0 | 4,1 | 3,1 |
13 | 8 | 0,89 | 159 | 84 | 5,5 | - | 193 | 165 | 117 | - | 40 | - | 179 | 159 | 1,6 | 0,9 | 35,4 | 35,0 | 11,2 | 19,3 | 3,2 | 3,2 | 7,4 | 8,5 |
14 | 4 | - | 106 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
15 | 7 | 0,1 | 85 | 134 | 5,2 | - | 155 | 127 | 107 | 65 | 35 | 39 | 65 | 114 | 1,4 | 1,4 | 67,4 | 90,3 | 23,8 | 35,2 | 4,1 | 3,6 | 5,3 | 6,0 |
16 |
12
| 2 | 79 | 85 | 5,5 | - | 231 | 223 | 138 | 125 | 77 | 65 | 82 | 167 | 0,7 | 0,6 | 35,7 | 35,0 | 22,8 | 22,4 | 4,8 | 4,1 | 5,1 | 6,5 |
n
|
12
|
16
|
11
|
11
|
4
|
9
|
9
|
10
|
9
|
10
|
8
|
10
|
8
|
15
|
12
|
14
|
11
|
15
|
11
|
13
|
10
|
15
|
12
| |
ME
|
1,8
|
103
|
93
|
5,3
|
5,3
|
185
|
165
|
108
|
92
|
61
|
52
|
89
|
131
|
0,8
|
0,8
|
31,7
|
37,8
|
29,9
|
25,9
|
4,2
|
4,0
|
5,5
|
6,4
| |
SD
|
2,3
|
27
|
16
|
0,4
|
0,3
|
44
|
48
|
36
|
45
|
19
|
17
|
51
|
47
|
0,3
|
0,3
|
12,6
|
19,4
|
22,2
|
11,9
|
0,5
|
0,6
|
1,5
|
1,2
|