Clinical trial to analyze the impact of nutrition and physical exercise intervention program on the completion of treatment in older patients 70 years or older with malignant hemopathology
OBJECTIVE: This study aims to determine wether a geriatric intervention based on an individualized program of physical exercise and nutritional support improves the ability to complete oncological treatment at the doses and time initially planned in patients ≥ 70 years affected by hematological malignancies. DESIGN: Prospective, clinical trial, randomized, parallel and open groups. SETTING: Patients ≥ 70 years recently diagnosed of malignant hematological pathology in a comprehensive cancer center INTERVENTION: All those patients who meet the inclusion criteria and agree to participate, will sign the corresponding informed consent and will be assessed through a CGA (comprehensive geriatric assessment), that includes the performance of a physical condition test (SPPB), and randomized to the study group or control group. Patients in the study group will participate in an intervention program with nutritional support and physical exercise during the period in which they are receiving oncological treatment or for a maximum period of 6 months. The patients of the control group will pass to follow up. All patients, regardless of the branch of study to which they are assigned, will receive the oncological treatment indicated by their doctor and a standard follow-up according to the current care protocols in the center. DETERMINATIONS: Main variable: proportion of adherence to treatment calculated as the percentage between the dose administered and the prescribed. Adherence over 80% will be considered acceptable. Secondary variables: geriatric, nutritional and physical-condition parameters before and after the intervention, quality of life before and after the intervention, toxicity and complications during treatment and response to treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
Nutritional support will be given to all patients according with their nutritional body composition parameters (Nutritional assessment and sarcopenia evaluation). It could be diet counselling, oral supplemented nutrition, enteral nutrition o parenteral nutrition.
The exercise program, designed, applied and monitored by research staff of the Physiology Unit, will have duration of 24 weeks (6 months). The program will have a mixed structure, the participants in an individual way fulfill their training and attend group sessions (8 subjects). In addition, 3 days a week should conduct sessions that will focus on the work of balance and general strength.
The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITINGAdherence to oncological treatment
Percentage between the dose administered and the prescribed.
Time frame: Change from baseline and after finishing treatment or 6 months
Risk of vulnerability
Vulnerable Elders Survey (VES-13) (numeric variable)
Time frame: Baseline versus 6 months (end of intervention) versus 12 months
Geriatric assessment
Geriatric Assessment in Hematology (GAH scale) (numeric variable)
Time frame: Baseline versus 6 months (end of intervention) versus 12 months
Nutritional screening
Mini-Nutritional Assessment (MNA) (numeric variable)
Time frame: Baseline versus 6 months (end of intervention) versus 12 months
Functional capacity
Basic activities of daily life (ABVD) - (Barthel scale) and instrumental activities of daily life (IADL) (Lawton-Body scale), fatigue (Borg scale) (numeric variable)
Time frame: Baseline versus 6 months (end of intervention) versus 12 months
Physical condition screening
Short Portable Physical Performance (SPPB) test. Numeric variable.
Time frame: Change from baseline versus 6 months (end of intervention) versus 12 months
Physical condition tests
Walking test 4 metres, Up-and-go test (seconds)
Time frame: Baseline versus 6 months (end of intervention) versus 12 months
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Body mass index
Weight and height will be combined to report body mass index (BMI) in kg/m2
Time frame: Baseline versus 6 months (end of intervention) versus 12 months
Anthropometric evaluation
Anthropometric evaluation of waist, hip, arm, thigh and leg perimeters (cm).
Time frame: Baseline versus 6 months (end of intervention) versus 12 months
Body composition
Body mass measured with electrical bioimpedance
Time frame: Baseline versus 6 months (end of intervention) versus 12 months
Performance of muscular strength
Strength measured by Isometric dynamometry of hands (hand grip) and legs (flex-extension) (KgF)
Time frame: Baseline versus 6 months (end of intervention) versus 12 months
Functional capacity assessment
6-minute walk test to assess functional capacity.
Time frame: Change from baseline versus 6 months (end of intervention) versus 12 months
Assessment of lower limbs strengh
Test to sit and get up in 30 seconds
Time frame: Change from baseline versus 6 months (end of intervention) versus 12 months
Average number of exercise sessions completed
Number of exercise sessions completed by each participant in the intervention group.
Time frame: Through study completion, an average of 6 months
Incidence of adverse effects
Frequency and severity of adverse effects according to CTCAE v4.
Time frame: Through study completion, an average of 6 months
Quality of life Assessment
Quality of Life Assessment: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ)for old patients with cancer. (EORTC QLQ-ELD14): numeric variable.
Time frame: Change from baseline versus 6 months (end of intervention) versus 12 months
Disease progression
Time to treatment failure, time to disease progression or death from any cause, and time to disease progression
Time frame: Change from baseline and after 2 years
Survival
Disease-free survival, overall survival, and cancer-specific survival.
Time frame: Change from baseline and after 2 years