Is fasting (and fasting -like diets) safe and effective for patients who undergo active oncological treatment?

reference

Valdemarin f, Caffa I, Persia a, et al. Security and feasibility of fasting-like nutrition and effects on nutritional status and circulating metabolic and inflammatory factors in Cancer patients that undergo active treatment. cancer (Basel) . 2021; 13 (16): 4013.

study goal

evaluation of the feasibility, safety and effect of a fasting -like diet (FMD) during the treatment of cancer with a variety of different cancer medication

Key to take

The MKS is safe and relatively well tolerated in patients who undergo active treatment against different types of cancer when monitored and adapted to the specific needs of the individual patient.

draft

one-armed, consistently clinical phase I/II study in Italy

participant

There were 90 original participants (86 % female), with 81 completing at least 1 FMD cycle and completing 65 participants 2 to 21 FMD cycles.

The majority of the participants had breast cancer (n = 62), with 36 hormone receptor (HR) positive tumors and 26 HR negative tumors. The remaining 14 % of the participants had a total of 18 different types of tumor.

At the time of the enrollment, the average age was 50.4 years (area 19–72) and the average body mass index (BMI) 25.9 (19–44) kg/m 2 . All participants were actively treated against cancer.

intervention

The intervention consisted of a “five-day, low-calorie and protein diet, which provides about 4,600 kJ (1,099 kcal) on day 1 (11 % protein, 46 % fat and 43 % carbohydrates), approx. 3,000 kJ (717 kcal) (9 % protein, 44 % fat and 47 % carbohydrates) on the days 2–5 There is ingredients that, according to the FDA, are all generally recognized as safe (grass). " (L-Nutra, proprietary product).

In the meantime, the participants were instructed between the MKS cycles, specific calories (20–30 kcal/kg weight/day) and protein (1.2–1.5 g protein/kg weight/day, mainly from fish, legumes, eggs, and milk products). They also received specific instructions for muscle training, which included detailed exercises (every exercise demonstrated, with repetitions and rest periods given) to promote a light to moderate participation of different muscle groups for 20 to 30 minutes or 500 to 600 kJ/day.

In patients who received chemotherapy, the 5-day FMD 4 days before chemotherapy and chemotherapy was carried out. For participants who received other treatments (e.g. hormone modulators, targeted active ingredients), the FMD was carried out either monthly or every 3 weeks.

Note: There was a change in the protocol if the phase angle showed a muscle mass loss without relaxation. With a low phase angle (5.0–5.2 degrees), the FMD was reduced to 3 to 4 days. At less than 5.0, the corresponding FMD was not administered, amino acids (aminotrofic ® : 5.5 g 2 times a day), and the patient was examined again after 4 weeks.

study parameters evaluated

body composition: The measurements included fat -free mass, fat mass, phase angle, ratio of extracellular mass to body cell mass (ECM/BCM), total body water and intracellular water. The parameters were fasted after at least 3 hours of fasting with a single frequency bioimpedance analyzer (BIA 101 ® , Akern, Florence, Italy). These measurements were then processed with the Bodygram Plus ® software (Akern, Florence, Italy).

The handle thickness was rated using a dynamometer (TKK 5001 Grip a Hand Grip Analogue Dynamometer, Takei, Japan).

CT scans, which were ordered as part of the ongoing monitoring of selected patients, were used to estimate the muscle mass at the level of the cross-processes of the third lumbar vertebra (L3) (bony orientation point; n = 6 participants).

Blood parameters: Blood values ​​including "Leptin, obonectin, resist, C-peptide (as a representative for insulin production), IGF1, insulin-like growth factor-binding protein 1 (IGFBP1), IGFBP3, Matrix metaloproteinase 8 (MMP8), MMP9, myeloperoxidase (MPO), fabric inhibitor of the metaloproteinase 1 (TIMP1), TIMP2, MMP9/TIMP1 complex (m/t c), osteopontin (opn), intercellular adhesion molecule 1 (icam1), vascular celladhesion molecule 1 (VCAM1), sclerostine, interleukin-6 (IL-6) and C-reactive protein (HS-CRP) ”was carried out after fasting overnight in the enrollment and before each FMD cycle.

Patients who were able to return to the hospital immediately before the start of the new diet was also taken from their serum at this time, so that the researchers could measure the mirrors of the same factors at the end of the MKS period.

primary result measurements

Acute MKS changes (measured directly according to MKS): C-peptide (a proxy for insulin production), IGF1, leptin and IGFBP3 levels were reduced. There was no impact of the diet on IGFBP1, resist, oboneectin or any of the tested cyto/chemokines and adhesion molecules.

Changes after a complete cycle (shortly before MKS, then 2 to 3 weeks after a cycle and healthy diet plus movement): The leptin, IGF1 and IGFBP3 levels remained lower compared to the starting values, while the oboneectine and IGFBP1 levels were higher. The researchers again found that no significant effect of the FMD was found on one of the tested cyto/chemocines.

important knowledge

While the muscle mass was finally preserved, weight loss was usually 2 to 2.5 kg during the MKS. A total of 27 patients (30 %) showed a significant decrease in the phase angle and the fat-free mass after 1 of their FMD cycles. (In these cases, the following FMD cycles were shortened to 3 or 4 days.) Ten patients (11 %) suffered a drop in their phase angle value below 5 degrees. These results suggest that careful monitoring is required for the safe use of MKS.

transparency

Two of the authors are shown as the inventor of patents for medical applications of fasting and the FMD in Oncology, and 1 author holds a capital participation in L-Nutra Inc., the company whose product was used in the study.

practice implications

If we approach fasting in integrative oncology, we must first keep an eye on security. One of the hard fights that are calorie restriction and fasting is that we, as a society, want to feed the sick. In addition, there is the fact that cancer is usually an illness of the waste of food, whereby Kachexia is a real risk for patients with advanced cancer. It is not surprising that many doctors are resisting the idea of ​​fasting their patients due to their concerns about their concerns.

preclinical data have shown many mechanisms and advantages of fasting/calorie restriction in animals, and we must certainly advance this for humans. MKS tries to imitate total fasting state through targeted lack of macronutrients, which allows a person to eat and to alleviate the concerns of treating doctors and hesitation of patients. As a practitioner who uses FMD and Fastet myself, I know that there is a good security and useful level, and this study shows that if you monitor carefully, it is both safe and feasible for those who undergo cancer treatment. The blood test confirms that FMDS actually reach some of the end points that are assumed that they benefit from the fasting, such as: B. the reduction of IGF-1.

clinically I suspected that it makes sense to fast patients due to some of the advantages against cancer that could have, even outside of a chemo scenario. A frequent scenario would be breast cancer patients who undergo endocrine therapy. In this study it says: “These results are particularly relevant in view of the fact that it was previously shown that reduced blood levels by insulin, IGF1 and Leptin strengthen the activity of chemotherapy, endocrine therapies and inhibitors of the PI3K-MTOR signal path. The end of the MKS period remained lower than at the beginning, while adiponeectin and IGFBP1 remained higher. We have long observed the advantages of fasting in our patients, especially with regard to inflammation and healthy cell sales. Now the direct connections to the anti -cancer mechanism are made.

We have long observed the advantages of fasting in our patients, especially with regard to inflammation and healthy cell sales. ”

In order to put this study in the context of the state of fasting, we still try to get better human data in order to confirm the large amount of preclinical data we have. There were some very promising small pilot studies early on, that of Longo et al. were carried out and published in 2009. In a newer review of the data, we have clarified more mechanisms and our understanding, but the authors come to the conclusion that even more human data is needed. ^{3 It makes sense that the costs for the implementation of large -scale human studies for fasting without an economic driver such as an economic driver are unaffected.}

This study was sponsored by a company, L-Nutra, which produces and sells the MKS product used. It would be ideal to have future studies carried out by independent third parties to confirm the favorable changes and the clinical challenges that have occurred.

This paper is strengthened and builds on the developing justification for the use of fasting as a tool in various oncological applications, at least for nutritional patients. It is difficult to make too many direct claims from this type of study because it was designed to show basic security and feasibility. In practice, I saw the advantages of fasting in several scenarios and felt good for many years of experience. The results of this study should further encourage other doctors that MKS can be used safely, even in patients who undergo various cancer treatments.