Nutritional and Physical Exercise Intervention in Older Patients With Malignant Hemopathies
NCT ID: NCT04057443
Last Updated: 2019-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2019-04-11
2023-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Nutritional 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.
Physical 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.
Hematologic Drug
The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.
Control group
The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.
Hematologic Drug
The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.
Interventions
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Nutritional 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.
Physical 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.
Hematologic Drug
The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.
Eligibility Criteria
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Inclusion Criteria
* considered able to practice physical exercise
* signed informed consent
Exclusion Criteria
* considered unable to practice physical exercise
70 Years
ALL
No
Sponsors
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Institut d'Investigació Biomèdica de Bellvitge
OTHER
University of Barcelona
OTHER
Instituto de Salud Carlos III
OTHER_GOV
Maite Antonio, MD, Phd
OTHER
Responsible Party
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Maite Antonio, MD, Phd
Coordinator Oncohematogeriatrics Unit. Institut Català d'Oncologia
Principal Investigators
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Maite Antonio, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Institut Català d'Oncologia
Locations
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Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Maite Antonio, MD,PhD
Role: primary
References
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Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
Other Identifiers
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PR157/18
Identifier Type: OTHER
Identifier Source: secondary_id
ICOSENIORHEM
Identifier Type: -
Identifier Source: org_study_id