Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Hematologic Malignancy
  • Old Age; Debility
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Parallel designMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 70 years and 125 years
Gender
Both males and females

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 mali...

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.

Tracking Information

NCT #
NCT04057443
Collaborators
  • Institut d'Investigació Biomèdica de Bellvitge
  • University of Barcelona
  • Instituto de Salud Carlos III
Investigators
Principal Investigator: Maite Antonio, MD,PhD Institut Català d'Oncologia