Nutritional and Physical Exercise Intervention in Older Patients With Malignant Hemopathies

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Impact of a Nutritional and Physical Exercise Intervention Program on Oncological Treatment Completion in Patients ≥70 Years Old With Malignant Hemopathies:ICOSENIORHEM Randomized Clinical Trial

Conditions
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Hematologic Malignancy, Old Age; Debility

Intervention / Treatment
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* Other: Nutritional support
* Other: Physical exercise
* Drug: Hematologic Drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hematological pathology (myelodysplastic syndromes, lymphoproliferative syndromes, multiple myeloma) considered able to practice physical exercise signed informed consent Exclusion Criteria: other hematological pathology considered unable to practice physical exercise

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Patients in the intervention group will follow the standard treatment and follow-uo according to the clinical protocol of the institution and will participate in an intervention program with physical exercise and nutritional support during the period in which they are receiving oncological treatment or for a maximum period of 6 months. | Other: Nutritional support<br>* 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.<br>Other: Physical exercise<br>* 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.<br>Drug: Hematologic Drug<br>* The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.<br>|
| Active Comparator: Control group<br>The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution. | Drug: Hematologic Drug<br>* The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to oncological treatment | Percentage between the dose administered and the prescribed. | Change from baseline and after finishing treatment or 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of vulnerability | Vulnerable Elders Survey (VES-13) (numeric variable) | Baseline versus 6 months (end of intervention) versus 12 months | 
| Geriatric assessment | Geriatric Assessment in Hematology (GAH scale) (numeric variable) | Baseline versus 6 months (end of intervention) versus 12 months | 
| Nutritional screening | Mini-Nutritional Assessment (MNA) (numeric variable) | 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) | Baseline versus 6 months (end of intervention) versus 12 months | 
| Physical condition screening | Short Portable Physical Performance (SPPB) test. Numeric variable. | Change from baseline versus 6 months (end of intervention) versus 12 months | 
| Physical condition tests | Walking test 4 metres, Up-and-go test (seconds) | Baseline versus 6 months (end of intervention) versus 12 months | 
| Body mass index | Weight and height will be combined to report body mass index (BMI) in kg/m2 | Baseline versus 6 months (end of intervention) versus 12 months | 
| Anthropometric evaluation | Anthropometric evaluation of waist, hip, arm, thigh and leg perimeters (cm). | Baseline versus 6 months (end of intervention) versus 12 months | 
| Body composition | Body mass measured with electrical bioimpedance | 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) | Baseline versus 6 months (end of intervention) versus 12 months | 
| Functional capacity assessment | 6-minute walk test to assess functional capacity. | 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 | 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. | Through study completion, an average of 6 months | 
| Incidence of adverse effects | Frequency and severity of adverse effects according to CTCAE v4. | 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. | 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 | Change from baseline and after 2 years | 
| Survival | Disease-free survival, overall survival, and cancer-specific survival. | Change from baseline and after 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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older, physical exercise, nutrition support, hematologic malignancies, geriatric assessment, geriatric intervention