Nutritional and Physical Exercise Intervention in Older Patients With Malignant Hemopathies (ICOSENIORHEM)

Maite Antonio, MD, Phd

Status: Unknown

Conditions: Hematologic Malignancy; Old Age; Debility

Treatments: Other: Nutritional support; Drug: Hematologic Drug; Other: Physical exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04057443

ICOSENIORHEM

PR157/18 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Physical exercise

Other: Nutritional support

Drug: Hematologic Drug

Control group

Active Comparator group

Description:

The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.

Treatment:

Drug: Hematologic Drug