Stratification of Patients in Oncogeriatrics and Personalization of Interventions (ONKO-FRAIL)

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.

Study Overview

• Status: Recruiting
• Conditions: Oncology; Solid Tumor, Adult
• Intervention / Treatment: Other: Physical exercise

Detailed Description

It seems useful to have instruments that help to objectively evaluate the fragilty and comorbidity of patients with the intention of adequately indicating the administration of antineoplastic treatment. In addition, nowadays, with the arrival of new less toxic treatments, it is essential to make a good selection of the patients to be treated, since there is a risk of treating patients who are not going to benefit from an active treatment just for having more comfortable medications and with less toxicity.

There are several instruments that can help to better select the patients that the investigators are going to treat and to select the supportive care that can help to better tolerate the proposed treatments while maintaining the best possible quality of life. Some of those instruments are aimed at detecting fragility such as comprehensive geriatric assessment. They identify in more detail the different vulnerabilities that can affect the patient in the benefit vs. toxicity balance of the treatment and in the long-term quality of life

Many authors emphasize the importance of including a physical exercise program during and after cancer treatment. Despite this, older people with cancer usually have low levels of physical activity, and few adhere to the recommendations they receive from health centers. For this reason, involving older people with cancer in a regular physical activity program becomes a challenge for those in charge of health centers.

Some studies have shown that physical exercise can reduce the usual loss of functional capacity and reduce frailty during cancer treatment. On the other hand, physical exercise can help reduce pain, toxicity and improve the completion rate of systemic treatment. Recent studies have found that physical exercise on the days of chemotherapy cycles is safe and may be beneficial in reducing neuropathy and maintaining physical well-being. Additionally, physical exercise can impact one of the most common and strenuous adverse effects of cancer treatment, fatigue.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Research Platform Biogipuzkoa Health Research Institute; Phone Number: + 34 943 006140; Email: OSID.INVESTCLINICA@osakidetza.eus

Study Locations

• Spain
  • Bilbao, Spain, 48013
    • Recruiting
    • Hospital Universitario Basurto
  • Guipuzcoa
    • San Sebastián, Guipuzcoa, Spain, 20014
      • Recruiting
      • Hospital Universitario Donostia
      • Contact: Email: OSID.INVESTCLINICA@osakidetza.eus
  • Álava
    • Vitoria, Álava, Spain, 01009
      • Recruiting
      • Hospital Universitario de Araba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 ...

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: Interventionist group; The interventional group will add an individualized physical exercise program to the usual care.	Other: Physical exercise; Physical exercise
No Intervention: Control group; The control group will receive the usual care and hygiene recommendations of the movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Integral Geriatric Assessment -Socio-familial situation:	Abbreviated Gijón Scale (3-15 pts)	12 weeks
Integral Geriatric Assessment - Basic Activities of Daily Living ( BADL):	Barthel Index (0-100 pts)	12 weeks
Integral Geriatric Assessment -Instrumental Activities of Daily Living (IADL):	Lawton´s test (0-8 pts)	12 weeks
Integral Geriatric Assessment -Cognitive function:	Pfeiffer test (0-10 pts)	12 weeks
Integral Geriatric Assessment - Depression:	Yesavage test-short form (0-15 pts) (Yes/No)	12 weeks
Integral Geriatric Assessment -Nutritional status:	MNA-SF test (0-14)	12 weeks
Integral Geriatric Assessment -Polypharmacy:	Number of chronic drugs consumed by the patient	12 weeks
Integral Geriatric Assessment - Geriatric syndromes:	Immobility and pressure ulcers (Yes/No); instability and falls (Yes/No); urinary and faecal incontinence (Yes/No); dementia and acute confusional syndrome ( Yes//No); malnutrition (Yes/No); alterations in sight and hearing (Yes/No);constipation, faecal impaction (Yes/No);depression/insomnia (Yes/No)	12 weeks
Integral Geriatric Assessment -Pain:	VAS (0-10 pts)	12 weeks
Integral Geriatric Assessment - Emotional distress:	Stress thermometer (0-10 pts)	12 weeks
Cognitive function	- Montreal Cognitive Assessment (MOCA) test (0-30 pts)	12 weeks
Anthropometry - Weight:	Unit of measure: kg	12 weeks
Anthropometry - Height:	Unit of measure: cm	12 weeks
Anthropometry -Waist, hip and calf circumference:	Unit of measure: cm	12 weeks
Anthropometry -Blood pressure:	- Unit of measure: mmHg	12 weeks
Anthropometry 1: - Bioimpedance (in some centers) 1	· Resistance (Ω)	12 weeks
Anthropometry 2: - Bioimpedance (in some centers) 1	· Phase angle (º)	12 weeks
Biomarkers>> a.1 Inflammation markers (pg/ml or ng/ml):	- Interleukins 1beta, 2, 4, 6, and 8 (IL-1 b, IL-2, IL-4, IL-6, and IL-8/CXCL8).	12 weeks
Biomarkers>> a.2 Inflammation markers (pg/ml or ng/ml):	- Tumor necrosis factor alpha (TNFa)	12 weeks
Biomarkers>> a.3 Inflammation markers (pg/ml or ng/ml):	- Interferon gamma (IFN)	12 weeks
Biomarkers>> a.4 Inflammation markers (pg/ml or ng/ml):	- C-reactive protein (CRP)	12 weeks
Biomarkers>> a.5 Inflammation markers (pg/ml or ng/ml):	- Brain-derived neurotrophic factor (BDNF)	12 weeks
Biomarkers>> a.6 Inflammation markers (pg/ml or ng/ml):	- CMV serology	12 weeks
Biomarkers>> b.1 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):	- Insulin-derived growth factor (IGF-1).	12 weeks
Biomarkers>> b.2 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):	- Dehydroepiandrosterone sulfate (DHEA sulfate)	12 weeks
Biomarkers>> b.3 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):	- Vitamin D	12 weeks
Biomarkers>> b.4 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):	- Albumin	12 weeks
Biomarkers>> c. Hematological (AU):	Biomarkers in the cell fraction of blood samples. Panel of 7 genes related to aging and frailty in RNA extracted from blood leukocytes, by quantitative PCR (qPCR): EGR1, Hsa-miR454, DDX11L1, G0S2, GJB6, CXCL8 and NSF. This panel has been developed at Biodonostia as a diagnostic and frailty stratification tool (European Patent Application EP3599286).	12 weeks
Functional assessment and frailty: - Steep Ramp test (A)	>Heart rate (bpm)	12 weeks
Functional assessment and frailty: - Steep Ramp test (B)	>Time spent cycling (min/sec)	12 weeks
Functional assessment and frailty: - Steep Ramp test (C)	> Maximum W	12 weeks
Functional assessment and frailty: - Frailty	G8 scale ( 0-17); Fried Frailty Phenotype (0-5 pts)	12 weeks
Functional assessment and frailty: - Dynamic balance:	8 Foot Up and Go Test (8FUGT) (sec)	12 weeks
Functional assessment and frailty: - Physical activity: 1.Accelerometry	Sleep efficiency (%)	12 weeks
Functional assessment and frailty: - Physical activity: 2. Accelerometry	Moderate too vigorous physical activity (min/d)	12 weeks
Functional assessment and frailty: - Physical activity: 3. Accelerometry	Sedentary time (h/d)	12 weeks
Functional assessment and frailty: - Physical activity: 4. Accelerometry	Light physical activity (min/d)	12 weeks
Patient-reported outcomes (PRO): -Fatigue:	EORTC QLQ-FA12	12 weeks
Patient-reported outcomes (PRO): - Quality of life:	EORTC QLQ-C30	12 weeks
Patient-reported outcomes (PRO): - Nutrition:	Simplified Nutritional Appetite Questionnire	12 weeks
Patient-reported outcomes (PRO): - Cognition:	Cognitive Failures Questionnaire	12 weeks
Patient-reported outcomes (PRO): - Physical activity:	Godin Physical Activity Questionnaire	12 weeks
Adverse events (CTCAE)	Treatment discontinuation (Yes/ No); Dose reduction (Yes/ No); Percentage of treatment completed (Yes/ No); Completion of treatment (Yes/ No)	12 weeks
Factors related to physical exercise adherence	Beliefs, barriers, facilitators and self-efficacy in relation to physical exercise ( self-developed questionnaire)	12 weeks
Intervention assessment - Follow-up of the intervention	Self- developed questionnaire	12 weeks
Intervention assessment - Adverse events associated with the intervention	Self- developed questionnaire	12 weeks
Intervention assessment - Satisfaction with the intervention	Self- developed questionnaire	12 weeks

Collaborators and Investigators

• Sponsor: Asociacion Instituto Biodonostia

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2022
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: biomarkers; physical exercise; fragility; oncogeriatrics
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ONKO-FRAIL

Drug and device information, study documents

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