Acute myeloid leukemia and myelodysplatic syndrome: parenteral-, enteral- and only oral nutrition during remission induction treatment

Intensive treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) is highly toxic and has considerale gastrintestinal side effects, including anorexia, nausea, vomiting and mucositis often leading to oral pain and severe diarrhea. Hence, most patients experience prolonged periods of minimal inadequate oral intake, diminished nutrient absorption and increased loss of nutrients from the gut, resulting in deterioration of nutritional status. Malnutrition prior to and after hematopoietic stem cell transplantation is associated with hogher complication and lower survival rates. However, due to a lack of studies, especially randomized controlled trials, on nutritional interventions in AML/MDS patients receiving remission induction treatment, there are no evidence-based nutritional guidelines. As a result, there is variability in the use of of parenteral nutrition (PN) and enteral nutrition (EN) among hospitals providing intensive AML/MDS treatment, also in the Netherlands. Whereas some of the hospitals use EN as the first-choice nutritional intervention in AML/MDS patients who cannot achieve adequate oral nutrient intake, others use PN as the preferred route of nutrition administration or have a wait-and-see approach towards both EN and PN, limiting its use to severe and exceptional cases only.
Results from our retrospective study on changes in body weight and serum liver tests associated with PN compared with no PN during remission induction treatment showed better preservation of body weight with frequent versus exceptional use of PN without severe serum liver test abnormalities. However, body weight alone is not a reliable measure for determining nutritional status. In addition, the influence of EN was not investigated, while a few recent studies showed a trend towards fewer complications in enterally versus parenterally fed hematological patients who received intensive treatment. Therefore, in a prospective observational multicentre study, changes in body composition and its influence on muscle strength, functional capacity, quality of life and course of treatment will be investigated in 180 AML/MDS patients who receive EN, PN or only oral nutrition during intensive remission induction chemotherapy treatment. Furthermore, the tolerance of the different nutritional interventions (EN, PN, and only oral nutrition) will be investigated. The primary outcome measure is body composition (fat mass (index), fat free mass (index), muscle mass, fat distribution), which is measured by: height, body weight (changes), bioelectrical impedance analysis, upper arm (muscle) circumference, triceps skin fold thickness, upper arm fat - and upper arm muscle area, waist circumference, calf circumference). Secondary outcome measures are: functional capacity (6-minute walk test, ECOG / WHO Performance Status), muscle strength (handgrip strength, 30-seconds sit-to-stand test, stairclimb test), quality of life (EORTC QLQ-C30) , tolerance of PN, EN and only oral nutrition (reasons for early cessation of PN/EN, serum liver test values ​​(CTCAEv5.0), central line infections / 1000 catheter days, nutrition impact symptoms (Bristol Stool Chart and CTCAEv4.0 for diarrhea / constipation, CTCAEv4.0 for nausea and vomiting, WHO criteria for oral mucositis, Visual Analog Scale for appetite), nutritional intake (24-hour recall method)), nutritional status (PG-SGA) and course of treatment (complications, length of hospitalization, serum liver test abnormalities, chemotherapy-related toxicity, treatment-related mortality, progression-free survival, overall survival). The outcome measures are measured before, during and after treatment with remission induction chemotherapy.

We hypothesize that medical nutrition (PN and EN) compared with no medical nutrition (only oral nutrition) will be associated with better maintenance of nutritional status (fat- and fat free (muscle) mass and body weight), functional capacity, muscle strength, and better course of treatment (shorter duration of hospital admission, reduced chemotherapy-related toxicity, lower complication rates) and quality of life. Furthermore, we expect that EN will be a feasible first-choice nutritional intervention in AML/MDS patients during remission induction chemotherapy, but we expect that PN will be required later on during the treatment process in more than half of the AML/MDS patients treated with remission induction chemotherapy, due to (severe) gastro-intestinal problems.

Before commencement of remission-induction chemotherapy treatment (baseline), weekly during remission-induction chemotherapy treatment and at the end of remission-induction chemotherapy treatment

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