Stratification of Patients in Oncogeriatrics and Personalization of Interventions

NCT05131113 | Completed

• 1 other identifier: ONKO-FRAIL
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 3

Brief Summary

Multicenter randomized controlled trial. Patients will be randomly assigned to the control group or the intervention group in each of the health centers. The control group will receive the usual care, while the intervention group will add an individualized physical exercise program to the usual care. Cancer is a disease of the elderly. More than 65% of all malignancies affect this population. At the same time, the incidence of cancer cases increases and the need to better understand the biological characteristics of the disease, as well as those of the elderly who suffer from it, is highlighted. Oncogeriatrics is the area that addresses the care of the elderly patient with cancer, taking into account that physiological aging causes older people to have their own characteristics that require a differential approach in care. The low inclusion in clinical trials of elderly patients and the few specific trials carried out in this subpopulation together with the progressive aging of the population mean that the development of this area has become a priority in health policies. Therefore, there is a need to focus the research area on supervised physical exercise in older people with cancer in an innovative way, with the aim of generating new hypotheses that overcome existing limitations and facilitate the introduction into the health system of this type of interventions.

Conditions

Oncology; Solid Tumor, Adult

Keywords

fragility; physical exercise; biomarkers; oncogeriatrics

Outcome Measures

Primary Outcomes (1)

• Short Physical Performance Battery

  Short Physical Performance Battery (SPPB) evaluates balance, gait ability, and leg strength using a single tool. The score for each part is given in categorical modality (0-4). The best score will be 12 points. 1 point of change in the total score has demostrated to be of clinical relevance.

  12 weeks

Secondary Outcomes (47)

• Integral Geriatric Assessment -Socio-familial situation:

  12 weeks

• Integral Geriatric Assessment - Basic Activities of Daily Living ( BADL):

  12 weeks

• Integral Geriatric Assessment -Instrumental Activities of Daily Living (IADL):

  12 weeks

• Integral Geriatric Assessment -Cognitive function:

  12 weeks

• Integral Geriatric Assessment - Depression:

  12 weeks

Study Arms (2)

Control group

NO INTERVENTION

The control group will receive the usual care and hygiene recommendations of the movement

Interventionist group

EXPERIMENTAL

The interventional group will add an individualized physical exercise program to the usual care.

Other: Physical exercise

Interventions

Physical exercise OTHER

Physical exercise

Interventionist group

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients aged 70 or over.
• Solid cancer.
• Candidates for systemic treatment (chemotherapy, hormone therapy, biological therapies or immunotherapy) if the time that has elapsed since the last dose of treatment has been at least 1 month (washout period).
• Patients with breast, gynecological, lung, pleural, digestive, urological, ENT area, sarcomas, brain tumors, melanomas and patients with tumors of unknown origin will be included.Regarding tumor type and stage for patients with lymphoma: 1) Diffuse large B-cell NHL: include stages I-II if Bulky (\>7.5 cm) or R-IPI\>1. 2) Hodgkin lymphoma: stages I-II if Bulky (\>10 cm). 3) Follicular NHL and marginal NHL without GELF treatment criteria. 4) 80 years old receiving 6 R-mini CHOP cycles.

You may not qualify if:

• ECOG ≥3
• cases of advanced dementia
• serious psychiatric illnesses
• Lack of basic fluency in the Basque or Spanish language
• those patients unable to get up from the chair and walk independently with or without auxiliary device.
• Neither will those patients who participate in other studies in which they are undertaking a physical exercise program be included.
• Absolute or relative contraindications in which the risk of adverse effects outweighs the possible benefits such as unstable angina, acute symptomatic heart failure ...

Sponsors & Collaborators

• Biogipuzkoa Health Research Institute: lead

Study Sites (3)

Hospital Universitario Donostia

San Sebastián, Guipuzcoa, 20014, Spain

Location

Hospital Universitario Basurto

Bilbao, 48013, Spain

Location

Hospital Universitario de Araba

Vitoria-Gasteiz, Álava, 01009, Spain

Location

Related Publications (1)

• Garcia-Garcia J, Rodriguez-Larrad A, de Rituerto Zeberio MM, Mediavilla JG, Vicente BL, Artola NT, Etxetxipia IZ, Garmendia I, Alberro A, Otaegui D, Rabasco FB, Caffarel MM, Vrotsou K, Irazusta J, Arrieta H, Pelaez M, Belloso J, Basterretxea L. Effects of a 12-week multicomponent exercise programme on physical function in older adults with cancer: Study protocol for the ONKO-FRAIL randomised controlled trial. J Geriatr Oncol. 2025 Dec 5;17(2):102818. doi: 10.1016/j.jgo.2025.102818. Online ahead of print.

  PMID: 41352214 DERIVED

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: November 23, 2021
• Study Start: January 27, 2022
• Primary Completion: January 1, 2024
• Study Completion: May 3, 2024
• Last Updated: August 20, 2024

Record last verified: 2023-06

Locations

ES (3)