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
Overview
- Phase
- N/A
- Intervention
- Nutritional support
- Conditions
- Hematologic Malignancy
- Sponsor
- Maite Antonio, MD, Phd
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Adherence to oncological treatment
- Last Updated
- 6 years ago
Overview
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.
Investigators
Maite Antonio, MD, Phd
Coordinator Oncohematogeriatrics Unit. Institut Català d'Oncologia
L'Hospitalet de Llobregat
Eligibility Criteria
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
Arms & Interventions
Intervention group
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: Nutritional support
Intervention group
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: Physical exercise
Intervention group
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: Hematologic Drug
Control group
The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.
Intervention: Hematologic Drug
Outcomes
Primary Outcomes
Adherence to oncological treatment
Time Frame: Change from baseline and after finishing treatment or 6 months
Percentage between the dose administered and the prescribed.
Secondary Outcomes
- Risk of vulnerability(Baseline versus 6 months (end of intervention) versus 12 months)
- Geriatric assessment(Baseline versus 6 months (end of intervention) versus 12 months)
- Nutritional screening(Baseline versus 6 months (end of intervention) versus 12 months)
- Functional capacity(Baseline versus 6 months (end of intervention) versus 12 months)
- Physical condition screening(Change from baseline versus 6 months (end of intervention) versus 12 months)
- Physical condition tests(Baseline versus 6 months (end of intervention) versus 12 months)
- Body mass index(Baseline versus 6 months (end of intervention) versus 12 months)
- Anthropometric evaluation(Baseline versus 6 months (end of intervention) versus 12 months)
- Body composition(Baseline versus 6 months (end of intervention) versus 12 months)
- Performance of muscular strength(Baseline versus 6 months (end of intervention) versus 12 months)
- Functional capacity assessment(Change from baseline versus 6 months (end of intervention) versus 12 months)
- Assessment of lower limbs strengh(Change from baseline versus 6 months (end of intervention) versus 12 months)
- Average number of exercise sessions completed(Through study completion, an average of 6 months)
- Incidence of adverse effects(Through study completion, an average of 6 months)
- Quality of life Assessment(Change from baseline versus 6 months (end of intervention) versus 12 months)
- Disease progression(Change from baseline and after 2 years)
- Survival(Change from baseline and after 2 years)