Impact of a Tailored Nutritional and Physical Exercise Programme on Efficacy and Functional Outcomes in Older Patients with Hematological Malignancies Classified By Frailty Profile
Authors: Antonio Maite , Arnan Sangerman Montserrat , Domingo-Domenech Eva , González-Barca Eva , Javierre Casimiro , Hurtos Laura , Sola Judit , Sureda Anna , Borras Josep Maria 
Published: November 2019

BACKGROUND
As the result of population aging, hematologists increasingly face the challenge of effectively managing older adults with oncological diseases. The heterogeneity of the aging process means that chronological age does not serve as a pivotal variable on which the clinical or treatment decisions are based. To improve outcomes in older population it is critical to select treatment considering patients' frailty profile and patients' needs to ensure they complete the treatment proposedComprehensive geriatric assessment (CGA) is a gold-standard multidimensional tool to characterize older patients according to their biological frailty profile. CGA identifies patient- and condition-related factors that might be potentially reversible through subsequent clinical interventions
Older patient may present some degree of physical decline during the treatment due to variables related to the disease itself and/or to the treatment. This can lead to an accelerated decline from aging, affect their functional independence, their quality of life, and their ability to complete the treatment
There is evidence that nutritional support and physical exercise during and after oncological treatments provides benefits in muscular and aerobic condition, quality of life, fatigue and adherence to treatment. But data on hematological patient, usually treated with more intensive schemes associated with a higher incidence of cytopenia and fatigue is scarce
ENDPOINT
- PRIMARY
To determine the impact of an individualized geriatric intervention program of physical exercise and nutritional support on adherence to planned oncological treatment in patients ≥ 70 years with hematological malignancies
- SECONDARY Analyze the relation between CGA and aging biomarkersEvaluate adherence to the intervention programDetermine the rate of completion and causes for non-completion of treatmentMeasure at the beginning and end of intervention, and 6 months after treatment completion: The program's effect on physical condition parametersChanges in functional capacity: basic and instrumental activities of daily lifeLevels of fatigueQuality of lifeDetermine the incidence and degree of severity of toxicityDetermine treatment response parameters: time to treatment failure and to progression, disease-free, overall and cancer-specific survival
METHODS DESIGN Prospective clinical trial, randomized, parallel and open groupsSETTING Comprehensive cancer centerINCLUSION CRITERIA Histopathological diagnosis of hematological malignancies: multiple myeloma, lymphoproliferative syndromes and myelodisplastic syndromesPatients who meet criteria for medical treatment: chemotherapy, radiotherapy, immunotherapy or targeted therapiesPatients in optimal conditions to perform moderate intensity physical exercise (responsible doctor's judgement)Signature of informed consentEXCLUSION CRITERIA Failure to meet any of the inclusion criteria.INTERVENTION All patients will be assessed through a CGA. The intervention group will received the standard treatment according to the clinical protocol of the institution and will participate in a program of personalized physical exercise and nutritional support. The control group will be treated in a standard manner according to the institution's clinical protocolRANDOMIZATION Subjects will be assigned a 1.1 ratio to one of the groups using a simple randomisation methodMAIN VARIABLE: rate of treatment compliance (relationship between the prescribed dose and the dose administered)SECONDARY VARIABLES: CGA scales, aging biomarkers, nutritional parameters and basal body composition before and after the intervention, quality of life before and after the intervention, toxicity and complications during treatment and response to treatment.STATISTICAL ANALYSIS The comparability of the components of the intervention and control group will be analyzed by Chi square test (qualitative variables) and Student's t test and Wilcoxson test (quantitative variables). The analysis of the intervention will be carried out according to the intention of treatment. The main variable will be analyzed by comparison test of chi-square proportions and confidence intervals will be calculated. The variable will be measured at the end of the intervention, according to the degree of compliance with the nutritional and physical exercise program.

Disclosures
Domingo-Domenech: Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Travel expenses; Seattle Genetics: Research Funding; Bristol-Myers Squibb: Other: Travel expenses; Roche: Other: Travel expenses. González-Barca:Kiowa: Consultancy; Roche: Consultancy, Honoraria; Celgene: Consultancy; Celtrion: Consultancy; AbbVie: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Takeda: Honoraria. Sureda:Roche: Honoraria; BMS: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Gilead: Consultancy; Sanofi: Consultancy, Honoraria; Takeda: Consultancy, Honoraria, Speakers Bureau.