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Completed

NCT Number: NCT05131113

Stratification of Patients in Oncogeriatrics and Personalization of Interventions

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.

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Key information

Age range

70 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Donostia, San Sebastián, Guipuzcoa, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ...

Treatment and study plan

Physical exercise

Other

Physical exercise

Primary outcomes

  1. Short Physical Performance Battery

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Integral Geriatric Assessment -Socio-familial situation:

    Time frame: 12 weeks

    Abbreviated Gijón Scale (3-15 pts)

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

    Time frame: 12 weeks

    Barthel Index (0-100 pts)

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

    Time frame: 12 weeks

    Lawton´s test (0-8 pts)

  4. Integral Geriatric Assessment -Cognitive function:

    Time frame: 12 weeks

    Pfeiffer test (0-10 pts)

  5. Integral Geriatric Assessment - Depression:

    Time frame: 12 weeks

    Yesavage test-short form (0-15 pts) (Yes/No)

  6. Integral Geriatric Assessment -Nutritional status:

    Time frame: 12 weeks

    MNA-SF test (0-14)

  7. Integral Geriatric Assessment -Polypharmacy:

    Time frame: 12 weeks

    Number of chronic drugs consumed by the patient

  8. Integral Geriatric Assessment - Geriatric syndromes:

    Time frame: 12 weeks

    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)

  9. Integral Geriatric Assessment -Pain:

    Time frame: 12 weeks

    VAS (0-10 pts)

  10. Integral Geriatric Assessment - Emotional distress:

    Time frame: 12 weeks

    Stress thermometer (0-10 pts)

  11. Cognitive function

    Time frame: 12 weeks

    • Montreal Cognitive Assessment (MOCA) test (0-30 pts)
  12. Anthropometry - Weight:

    Time frame: 12 weeks

    Unit of measure: kg

  13. Anthropometry - Height:

    Time frame: 12 weeks

    Unit of measure: cm

  14. Anthropometry -Waist, hip and calf circumference:

    Time frame: 12 weeks

    Unit of measure: cm

  15. Anthropometry -Blood pressure:

    Time frame: 12 weeks

    • Unit of measure: mmHg
  16. Anthropometry 1: - Bioimpedance (in some centers) 1

    Time frame: 12 weeks

    · Resistance (Ω)

  17. Anthropometry 2: - Bioimpedance (in some centers) 1

    Time frame: 12 weeks

    · Phase angle (º)

  18. Biomarkers>> a.1 Inflammation markers (pg/ml or ng/ml):

    Time frame: 12 weeks

    • Interleukins 1beta, 2, 4, 6, and 8 (IL-1 b, IL-2, IL-4, IL-6, and IL-8/CXCL8).
  19. Biomarkers>> a.2 Inflammation markers (pg/ml or ng/ml):

    Time frame: 12 weeks

    • Tumor necrosis factor alpha (TNFa)
  20. Biomarkers>> a.3 Inflammation markers (pg/ml or ng/ml):

    Time frame: 12 weeks

    • Interferon gamma (IFN)
  21. Biomarkers>> a.4 Inflammation markers (pg/ml or ng/ml):

    Time frame: 12 weeks

    • C-reactive protein (CRP)
  22. Biomarkers>> a.5 Inflammation markers (pg/ml or ng/ml):

    Time frame: 12 weeks

    • Brain-derived neurotrophic factor (BDNF)
  23. Biomarkers>> a.6 Inflammation markers (pg/ml or ng/ml):

    Time frame: 12 weeks

    • CMV serology
  24. Biomarkers>> b.1 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):

    Time frame: 12 weeks

    • Insulin-derived growth factor (IGF-1).
  25. Biomarkers>> b.2 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):

    Time frame: 12 weeks

    • Dehydroepiandrosterone sulfate (DHEA sulfate)
  26. Biomarkers>> b.3 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):

    Time frame: 12 weeks

    • Vitamin D
  27. Biomarkers>> b.4 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):

    Time frame: 12 weeks

    • Albumin
  28. Biomarkers>> c. Hematological (AU):

    Time frame: 12 weeks

    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).

  29. Functional assessment and frailty: - Steep Ramp test (A)

    Time frame: 12 weeks

    >Heart rate (bpm)

  30. Functional assessment and frailty: - Steep Ramp test (B)

    Time frame: 12 weeks

    >Time spent cycling (min/sec)

  31. Functional assessment and frailty: - Steep Ramp test (C)

    Time frame: 12 weeks

    > Maximum W

  32. Functional assessment and frailty: - Frailty

    Time frame: 12 weeks

    G8 scale ( 0-17); Fried Frailty Phenotype (0-5 pts)

  33. Functional assessment and frailty: - Dynamic balance:

    Time frame: 12 weeks

    8 Foot Up and Go Test (8FUGT) (sec)

  34. Functional assessment and frailty: - Physical activity: 1.Accelerometry

    Time frame: 12 weeks

    Sleep efficiency (%)

  35. Functional assessment and frailty: - Physical activity: 2. Accelerometry

    Time frame: 12 weeks

    Moderate too vigorous physical activity (min/d)

  36. Functional assessment and frailty: - Physical activity: 3. Accelerometry

    Time frame: 12 weeks

    Sedentary time (h/d)

  37. Functional assessment and frailty: - Physical activity: 4. Accelerometry

    Time frame: 12 weeks

    Light physical activity (min/d)

  38. Patient-reported outcomes (PRO): -Fatigue:

    Time frame: 12 weeks

    EORTC QLQ-FA12

  39. Patient-reported outcomes (PRO): - Quality of life:

    Time frame: 12 weeks

    EORTC QLQ-C30

  40. Patient-reported outcomes (PRO): - Nutrition:

    Time frame: 12 weeks

    Simplified Nutritional Appetite Questionnire

  41. Patient-reported outcomes (PRO): - Cognition:

    Time frame: 12 weeks

    Cognitive Failures Questionnaire

  42. Patient-reported outcomes (PRO): - Physical activity:

    Time frame: 12 weeks

    Godin Physical Activity Questionnaire

  43. Adverse events (CTCAE)

    Time frame: 12 weeks

    • Treatment discontinuation (Yes/ No)
    • Dose reduction (Yes/ No)
    • Percentage of treatment completed (Yes/ No)
    • Completion of treatment (Yes/ No)
  44. Factors related to physical exercise adherence

    Time frame: 12 weeks

    Beliefs, barriers, facilitators and self-efficacy in relation to physical exercise ( self-developed questionnaire)

  45. Intervention assessment - Follow-up of the intervention

    Time frame: 12 weeks

    Self- developed questionnaire

  46. Intervention assessment - Adverse events associated with the intervention

    Time frame: 12 weeks

    Self- developed questionnaire

  47. Intervention assessment - Satisfaction with the intervention

    Time frame: 12 weeks

    Self- developed questionnaire

Sponsors and collaborators

Lead sponsor

Biogipuzkoa Health Research Institute

Other

Registry information

Acronym: ONKO-FRAIL

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 23, 2021
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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