Nutritional and Physical Exercise Intervention in Older Patients With Malignant Hemopathies
ICOSENIORHEM
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
2 other identifiers
interventional
80
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 11, 2019
CompletedFirst Submitted
Initial submission to the registry
June 11, 2019
CompletedFirst Posted
Study publicly available on registry
August 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedAugust 30, 2019
August 1, 2019
2.1 years
June 11, 2019
August 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence to oncological treatment
Percentage between the dose administered and the prescribed.
Change from baseline and after finishing treatment or 6 months
Secondary Outcomes (17)
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
- +12 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALPatients 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
ACTIVE COMPARATORThe patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.
Interventions
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.
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.
The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.
Eligibility Criteria
You may qualify if:
- hematological pathology (myelodysplastic syndromes, lymphoproliferative syndromes, multiple myeloma)
- considered able to practice physical exercise
- signed informed consent
You may not qualify if:
- other hematological pathology
- considered unable to practice physical exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maite Antonio, MD, Phdlead
- Institut d'Investigació Biomèdica de Bellvitgecollaborator
- University of Barcelonacollaborator
- Instituto de Salud Carlos IIIcollaborator
Study Sites (1)
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Related Publications (1)
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.
PMID: 39606939DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maite Antonio, MD,PhD
Institut Català d'Oncologia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Coordinator Oncohematogeriatrics Unit. Institut Català d'Oncologia
Study Record Dates
First Submitted
June 11, 2019
First Posted
August 15, 2019
Study Start
April 11, 2019
Primary Completion
June 1, 2021
Study Completion
June 1, 2023
Last Updated
August 30, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share