Nutritional and Physical Exercise Intervention in Older Patients With Malignant Hemopathies
- Conditions
- Old Age; DebilityHematologic Malignancy
- Interventions
- Other: Nutritional supportOther: Physical exerciseDrug: Hematologic Drug
- Registration Number
- NCT04057443
- Lead Sponsor
- Maite Antonio, MD, Phd
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- hematological pathology (myelodysplastic syndromes, lymphoproliferative syndromes, multiple myeloma)
- considered able to practice physical exercise
- signed informed consent
- other hematological pathology
- considered unable to practice physical exercise
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Hematologic Drug 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. Control group Hematologic Drug The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution. Intervention group Nutritional support 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. Intervention group Physical exercise 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.
- Primary Outcome Measures
Name Time Method Adherence to oncological treatment Change from baseline and after finishing treatment or 6 months Percentage between the dose administered and the prescribed.
- Secondary Outcome Measures
Name Time Method Risk of vulnerability Baseline versus 6 months (end of intervention) versus 12 months Vulnerable Elders Survey (VES-13) (numeric variable)
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
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)
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.
Trial Locations
- Locations (1)
Institut Català d'Oncologia
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain