Clinical trial NCT04057443: Nutritional and Physical Exercise Intervention in Older Patients With Malignant Hemopathies
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematologic Malignancy
Old Age; Debility
Keywords: older
physical exercise
nutrition support
hematologic malignancies
geriatric assessment
geriatric intervention
Lead sponsor: L'Hospitalet de Llobregat
Sponsor class: OTHER
Collaborators: name: Institut d'Investigació Biomèdica de Bellvitge
name: University of Barcelona
name: Instituto de Salud Carlos III
First posted: 2019-08-15
Enrollment: 80
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel design
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Adherence to oncological treatment
timeFrame: Change from baseline and after finishing treatment or 6 months
Secondary outcomes:
measure: Risk of vulnerability
timeFrame: Baseline versus 6 months (end of intervention) versus 12 months
measure: Geriatric assessment
timeFrame: Baseline versus 6 months (end of intervention) versus 12 months
measure: Nutritional screening
timeFrame: Baseline versus 6 months (end of intervention) versus 12 months
measure: Functional capacity
timeFrame: Baseline versus 6 months (end of intervention) versus 12 months
measure: Physical condition screening
timeFrame: Change from baseline versus 6 months (end of intervention) versus 12 months
measure: Physical condition tests
timeFrame: Baseline versus 6 months (end of intervention) versus 12 months
measure: Body mass index
timeFrame: Baseline versus 6 months (end of intervention) versus 12 months
measure: Anthropometric evaluation
timeFrame: Baseline versus 6 months (end of intervention) versus 12 months
measure: Body composition
timeFrame: Baseline versus 6 months (end of intervention) versus 12 months
measure: Performance of muscular strength
timeFrame: Baseline versus 6 months (end of intervention) versus 12 months
measure: Functional capacity assessment
timeFrame: Change from baseline versus 6 months (end of intervention) versus 12 months
measure: Assessment of lower limbs strengh
timeFrame: Change from baseline versus 6 months (end of intervention) versus 12 months
measure: Average number of exercise sessions completed
timeFrame: Through study completion, an average of 6 months
measure: Incidence of adverse effects
timeFrame: Through study completion, an average of 6 months
measure: Quality of life Assessment
timeFrame: Change from baseline versus 6 months (end of intervention) versus 12 months
measure: Disease progression
timeFrame: Change from baseline and after 2 years
measure: Survival
timeFrame: Change from baseline and after 2 years
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Català d'Oncologia
state: Barcelona
Study officials:
affiliation: Institut Català d'Oncologia
name: Maite Antonio, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: