Nutritional and Physical Exercise Intervention in Older Patients With Malignant Hemopathies

Hematologic Malignancy Clinical Trial

— ICOSENIORHEM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04057443
• Other study ID #: ICOSENIORHEM
• Secondary ID: PR157/18
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: August 2019
• Source: L'Hospitalet de Llobregat
• Contact: Maite Antonio, MD, PhD
• Phone: +34692083987
• Email: marebollo[@]iconcologia.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancy
• Neoplasms
• Old Age; Debility

Intervention

Other:
• 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.

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

Locations

Country	Name	City	State
Spain	Institut Català d'Oncologia	L'Hospitalet de Llobregat	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Maite Antonio, MD, Phd	Institut d'Investigació Biomèdica de Bellvitge, Instituto de Salud Carlos III, University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to oncological treatment	Percentage between the dose administered and the prescribed.	Change from baseline and after finishing treatment or 6 months
Secondary	Risk of vulnerability	Vulnerable Elders Survey (VES-13) (numeric variable)	Baseline versus 6 months (end of intervention) versus 12 months
Secondary	Geriatric assessment	Geriatric Assessment in Hematology (GAH scale) (numeric variable)	Baseline versus 6 months (end of intervention) versus 12 months
Secondary	Nutritional screening	Mini-Nutritional Assessment (MNA) (numeric variable)	Baseline versus 6 months (end of intervention) versus 12 months
Secondary	Functional capacity	Basic activities of daily life (ABVD) - (Barthel scale) and instrumental activities of daily life (IADL) (Lawton-Body scale), fatigue (Borg scale) (numeric variable)	Baseline versus 6 months (end of intervention) versus 12 months
Secondary	Physical condition screening	Short Portable Physical Performance (SPPB) test. Numeric variable.	Change from baseline versus 6 months (end of intervention) versus 12 months
Secondary	Physical condition tests	Walking test 4 metres, Up-and-go test (seconds)	Baseline versus 6 months (end of intervention) versus 12 months
Secondary	Body mass index	Weight and height will be combined to report body mass index (BMI) in kg/m2	Baseline versus 6 months (end of intervention) versus 12 months
Secondary	Anthropometric evaluation	Anthropometric evaluation of waist, hip, arm, thigh and leg perimeters (cm).	Baseline versus 6 months (end of intervention) versus 12 months
Secondary	Body composition	Body mass measured with electrical bioimpedance	Baseline versus 6 months (end of intervention) versus 12 months
Secondary	Performance of muscular strength	Strength measured by Isometric dynamometry of hands (hand grip) and legs (flex-extension) (KgF)	Baseline versus 6 months (end of intervention) versus 12 months
Secondary	Functional capacity assessment	6-minute walk test to assess functional capacity.	Change from baseline versus 6 months (end of intervention) versus 12 months
Secondary	Assessment of lower limbs strengh	Test to sit and get up in 30 seconds	Change from baseline versus 6 months (end of intervention) versus 12 months
Secondary	Average number of exercise sessions completed	Number of exercise sessions completed by each participant in the intervention group.	Through study completion, an average of 6 months
Secondary	Incidence of adverse effects	Frequency and severity of adverse effects according to CTCAE v4.	Through study completion, an average of 6 months
Secondary	Quality of life Assessment	Quality of Life Assessment: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ)for old patients with cancer. (EORTC QLQ-ELD14): numeric variable.	Change from baseline versus 6 months (end of intervention) versus 12 months
Secondary	Disease progression	Time to treatment failure, time to disease progression or death from any cause, and time to disease progression	Change from baseline and after 2 years
Secondary	Survival	Disease-free survival, overall survival, and cancer-specific survival.	Change from baseline and after 2 years