Hematologic Malignancy, Old Age; Debility
Conditions
Keywords
older, physical exercise, nutrition support, hematologic malignancies, geriatric assessment, geriatric intervention
Brief summary
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
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.
Interventions
OTHERNutritional support
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.
OTHERPhysical exercise
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.
DRUGHematologic Drug
The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.
Sponsors
Institut d'Investigació Biomèdica de Bellvitge
University of Barcelona
Instituto de Salud Carlos III
Maite Antonio, MD, Phd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Parallel design
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to oncological treatment | Change from baseline and after finishing treatment or 6 months | Percentage between the dose administered and the prescribed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geriatric assessment | Baseline versus 6 months (end of intervention) versus 12 months | Geriatric Assessment in Hematology (GAH scale) (numeric variable) |
| Nutritional screening | Baseline versus 6 months (end of intervention) versus 12 months | Mini-Nutritional Assessment (MNA) (numeric variable) |
| Functional capacity | Baseline versus 6 months (end of intervention) versus 12 months | Basic activities of daily life (ABVD) - (Barthel scale) and instrumental activities of daily life (IADL) (Lawton-Body scale), fatigue (Borg scale) (numeric variable) |
| Physical condition screening | Change from baseline versus 6 months (end of intervention) versus 12 months | Short Portable Physical Performance (SPPB) test. Numeric variable. |
| Physical condition tests | Baseline versus 6 months (end of intervention) versus 12 months | Walking test 4 metres, Up-and-go test (seconds) |
| Body mass index | Baseline versus 6 months (end of intervention) versus 12 months | Weight and height will be combined to report body mass index (BMI) in kg/m2 |
| Anthropometric evaluation | Baseline versus 6 months (end of intervention) versus 12 months | Anthropometric evaluation of waist, hip, arm, thigh and leg perimeters (cm). |
| Body composition | Baseline versus 6 months (end of intervention) versus 12 months | Body mass measured with electrical bioimpedance |
| Risk of vulnerability | Baseline versus 6 months (end of intervention) versus 12 months | Vulnerable Elders Survey (VES-13) (numeric variable) |
| Functional capacity assessment | Change from baseline versus 6 months (end of intervention) versus 12 months | 6-minute walk test to assess functional capacity. |
| Assessment of lower limbs strengh | Change from baseline versus 6 months (end of intervention) versus 12 months | Test to sit and get up in 30 seconds |
| Average number of exercise sessions completed | Through study completion, an average of 6 months | Number of exercise sessions completed by each participant in the intervention group. |
| Incidence of adverse effects | Through study completion, an average of 6 months | Frequency and severity of adverse effects according to CTCAE v4. |
| Quality of life Assessment | Change from baseline versus 6 months (end of intervention) versus 12 months | 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. |
| Disease progression | Change from baseline and after 2 years | Time to treatment failure, time to disease progression or death from any cause, and time to disease progression |
| Survival | Change from baseline and after 2 years | Disease-free survival, overall survival, and cancer-specific survival. |
| Performance of muscular strength | Baseline versus 6 months (end of intervention) versus 12 months | Strength measured by Isometric dynamometry of hands (hand grip) and legs (flex-extension) (KgF) |
Countries
Spain
Contacts
Primary ContactMaite Antonio, MD, PhD
Backup ContactJosep Maria Borras, MD,PhD,Prof
Outcome results
None listed