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

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

Study Overview

• Status: Recruiting
• Conditions: Hematologic Malignancy; Old Age; Debility
• Intervention / Treatment: Other: Nutritional support; Other: Physical exercise; Drug: Hematologic Drug

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maite Antonio, MD, PhD; Phone Number: +34692083987; Email: marebollo@iconcologia.net
• Study Contact Backup: Name: Josep Maria Borras, MD,PhD,Prof; Phone Number: +34932607417; Email: jmborras@iconcologia.net

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
      • Recruiting
      • Institut Catala d'Oncologia
      • Contact: Maite Antonio, MD,PhD; Phone Number: +34692083987; Email: marebollo@iconcologia.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other: 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.
Active Comparator: Control group; The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to oncological treatment	Percentage between the dose administered and the prescribed.	Change from baseline and after finishing treatment or 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of vulnerability	Vulnerable Elders Survey (VES-13) (numeric variable)	Baseline versus 6 months (end of intervention) versus 12 months
Geriatric assessment	Geriatric Assessment in Hematology (GAH scale) (numeric variable)	Baseline versus 6 months (end of intervention) versus 12 months
Nutritional screening	Mini-Nutritional Assessment (MNA) (numeric variable)	Baseline versus 6 months (end of intervention) versus 12 months
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
Physical condition screening	Short Portable Physical Performance (SPPB) test. Numeric variable.	Change from baseline versus 6 months (end of intervention) versus 12 months
Physical condition tests	Walking test 4 metres, Up-and-go test (seconds)	Baseline versus 6 months (end of intervention) versus 12 months
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
Anthropometric evaluation	Anthropometric evaluation of waist, hip, arm, thigh and leg perimeters (cm).	Baseline versus 6 months (end of intervention) versus 12 months
Body composition	Body mass measured with electrical bioimpedance	Baseline versus 6 months (end of intervention) versus 12 months
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
Functional capacity assessment	6-minute walk test to assess functional capacity.	Change from baseline versus 6 months (end of intervention) versus 12 months
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
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
Incidence of adverse effects	Frequency and severity of adverse effects according to CTCAE v4.	Through study completion, an average of 6 months
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
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
Survival	Disease-free survival, overall survival, and cancer-specific survival.	Change from baseline and after 2 years

Collaborators and Investigators

• Sponsor: Maite Antonio, MD, Phd
• Collaborators: Institut d'Investigació Biomèdica de Bellvitge; Instituto de Salud Carlos III; University of Barcelona
• Investigators: Principal Investigator: Maite Antonio, MD,PhD, Institut Catala d'Oncologia

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 28, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: physical exercise; hematologic malignancies; older; geriatric assessment; nutrition support; geriatric intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms; Frailty
• Other Study ID Numbers: ICOSENIORHEM; PR157/18 (Other Identifier: Independent review board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No