OncologyONKO-FRAILNCT05131113
Stratification of Patients in Oncogeriatrics and Personalization of Interventions
A study testing Physical exercise in people with Oncology and Solid Tumor, Adult, run by Biogipuzkoa Health Research Institute at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Oncology, Solid Tumor, Adult
- What is being tested?
- Physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 3 sitesSpain
- Study dates
- 27 Jan 2022to 3 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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 ...
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitario Basurto
Bilbao, 48013
Hospital Universitario Donostia
San Sebastián, Guipuzcoa, 20014
Hospital Universitario de Araba
Vitoria-Gasteiz, Álava, 01009
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Oncology, Solid Tumor, Adult
- Being tested
- Physical exercise
- Keywords
- fragility, physical exercise, biomarkers, oncogeriatrics
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
Physical exercise
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (47)
Integral Geriatric Assessment -Socio-familial situation:
Abbreviated Gijón Scale (3-15 pts)
Measured: 12 weeks
Integral Geriatric Assessment - Basic Activities of Daily Living ( BADL):
Barthel Index (0-100 pts)
Measured: 12 weeks
Integral Geriatric Assessment -Instrumental Activities of Daily Living (IADL):
Lawton´s test (0-8 pts)
Measured: 12 weeks
Integral Geriatric Assessment -Cognitive function:
Pfeiffer test (0-10 pts)
Measured: 12 weeks
Integral Geriatric Assessment - Depression:
Yesavage test-short form (0-15 pts) (Yes/No)
Measured: 12 weeks
Integral Geriatric Assessment -Nutritional status:
MNA-SF test (0-14)
Measured: 12 weeks
Integral Geriatric Assessment -Polypharmacy:
Number of chronic drugs consumed by the patient
Measured: 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)
Measured: 12 weeks
Integral Geriatric Assessment -Pain:
VAS (0-10 pts)
Measured: 12 weeks
Integral Geriatric Assessment - Emotional distress:
Stress thermometer (0-10 pts)
Measured: 12 weeks
Cognitive function
- Montreal Cognitive Assessment (MOCA) test (0-30 pts)
Measured: 12 weeks
Anthropometry - Weight:
Unit of measure: kg
Measured: 12 weeks
Anthropometry - Height:
Unit of measure: cm
Measured: 12 weeks
Anthropometry -Waist, hip and calf circumference:
Unit of measure: cm
Measured: 12 weeks
Anthropometry -Blood pressure:
- Unit of measure: mmHg
Measured: 12 weeks
Anthropometry 1: - Bioimpedance (in some centers) 1
- Resistance (Ω)
Measured: 12 weeks
Anthropometry 2: - Bioimpedance (in some centers) 1
- Phase angle (º)
Measured: 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).
Measured: 12 weeks
Biomarkers>> a.2 Inflammation markers (pg/ml or ng/ml):
- Tumor necrosis factor alpha (TNFa)
Measured: 12 weeks
Biomarkers>> a.3 Inflammation markers (pg/ml or ng/ml):
- Interferon gamma (IFN)
Measured: 12 weeks
Biomarkers>> a.4 Inflammation markers (pg/ml or ng/ml):
- C-reactive protein (CRP)
Measured: 12 weeks
Biomarkers>> a.5 Inflammation markers (pg/ml or ng/ml):
- Brain-derived neurotrophic factor (BDNF)
Measured: 12 weeks
Biomarkers>> a.6 Inflammation markers (pg/ml or ng/ml):
- CMV serology
Measured: 12 weeks
Biomarkers>> b.1 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):
- Insulin-derived growth factor (IGF-1).
Measured: 12 weeks
Biomarkers>> b.2 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):
- Dehydroepiandrosterone sulfate (DHEA sulfate)
Measured: 12 weeks
Biomarkers>> b.3 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):
- Vitamin D
Measured: 12 weeks
Biomarkers>> b.4 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):
- Albumin
Measured: 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).
Measured: 12 weeks
Functional assessment and frailty: - Steep Ramp test (A)
>Heart rate (bpm)
Measured: 12 weeks
Functional assessment and frailty: - Steep Ramp test (B)
>Time spent cycling (min/sec)
Measured: 12 weeks
Functional assessment and frailty: - Steep Ramp test (C)
> Maximum W
Measured: 12 weeks
Functional assessment and frailty: - Frailty
G8 scale ( 0-17); Fried Frailty Phenotype (0-5 pts)
Measured: 12 weeks
Functional assessment and frailty: - Dynamic balance:
8 Foot Up and Go Test (8FUGT) (sec)
Measured: 12 weeks
Functional assessment and frailty: - Physical activity: 1.Accelerometry
Sleep efficiency (%)
Measured: 12 weeks
Functional assessment and frailty: - Physical activity: 2. Accelerometry
Moderate too vigorous physical activity (min/d)
Measured: 12 weeks
Functional assessment and frailty: - Physical activity: 3. Accelerometry
Sedentary time (h/d)
Measured: 12 weeks
Functional assessment and frailty: - Physical activity: 4. Accelerometry
Light physical activity (min/d)
Measured: 12 weeks
Patient-reported outcomes (PRO): -Fatigue:
EORTC QLQ-FA12
Measured: 12 weeks
Patient-reported outcomes (PRO): - Quality of life:
EORTC QLQ-C30
Measured: 12 weeks
Patient-reported outcomes (PRO): - Nutrition:
Simplified Nutritional Appetite Questionnire
Measured: 12 weeks
Patient-reported outcomes (PRO): - Cognition:
Cognitive Failures Questionnaire
Measured: 12 weeks
Patient-reported outcomes (PRO): - Physical activity:
Godin Physical Activity Questionnaire
Measured: 12 weeks
Adverse events (CTCAE)
- Treatment discontinuation (Yes/ No)
- Dose reduction (Yes/ No)
- Percentage of treatment completed (Yes/ No)
- Completion of treatment (Yes/ No)
Measured: 12 weeks
Factors related to physical exercise adherence
Beliefs, barriers, facilitators and self-efficacy in relation to physical exercise ( self-developed questionnaire)
Measured: 12 weeks
Intervention assessment - Follow-up of the intervention
Self- developed questionnaire
Measured: 12 weeks
Intervention assessment - Adverse events associated with the intervention
Self- developed questionnaire
Measured: 12 weeks
Intervention assessment - Satisfaction with the intervention
Self- developed questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start27 Jan 2022
- Primary completion1 Jan 2024
- Study completion3 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogipuzkoa Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131113
- Sponsor's protocol ID
- ONKO-FRAIL
- Acronym
- ONKO-FRAIL
- Status last verified
- Jun 2023
- First submitted
- 29 Jul 2021
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garcia-Garcia J, Rodriguez-Larrad A, de Rituerto Zeberio MM, Mediavilla JG, Vicente BL, Artola NT, Etxetxipia IZ, Garmendia I, Alberro A, Otaegui D, Borrego F, 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. 2026 Mar;17(2):102818. doi: 10.1016/j.jgo.2025.102818. Epub 2025 Dec 5.
PubMed 41352214
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratification of Patients in Oncogeriatrics and Personalization of Interventions
- ClinicalTrials.gov ID
- NCT05131113
- Acronym / sponsor ID
- ONKO-FRAIL / ONKO-FRAIL
- Conditions
- Oncology, Solid Tumor, Adult
- Keywords
- fragility, physical exercise, biomarkers, oncogeriatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Biogipuzkoa Health Research InstituteUniversity, hospital or other
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will receive the usual care and hygiene recommendations of the movement |
| Interventionist group | Experimental | Other: Physical exerciseThe interventional group will add an individualized physical exercise program to the usual care. |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exercisePhysical exercise | Other | Interventionist group |
Primary outcome
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.
47 secondary outcomes
Integral Geriatric Assessment -Socio-familial situation:
Time frame: 12 weeks
Integral Geriatric Assessment - Basic Activities of Daily Living ( BADL):
Time frame: 12 weeks
Integral Geriatric Assessment -Instrumental Activities of Daily Living (IADL):
Time frame: 12 weeks
Integral Geriatric Assessment -Cognitive function:
Time frame: 12 weeks
Integral Geriatric Assessment - Depression:
Time frame: 12 weeks
Integral Geriatric Assessment -Nutritional status:
Time frame: 12 weeks
Integral Geriatric Assessment -Polypharmacy:
Time frame: 12 weeks
Integral Geriatric Assessment - Geriatric syndromes:
Time frame: 12 weeks
Integral Geriatric Assessment -Pain:
Time frame: 12 weeks
Integral Geriatric Assessment - Emotional distress:
Time frame: 12 weeks
Cognitive function
Time frame: 12 weeks
Anthropometry - Weight:
Time frame: 12 weeks
Anthropometry - Height:
Time frame: 12 weeks
Anthropometry -Waist, hip and calf circumference:
Time frame: 12 weeks
Anthropometry -Blood pressure:
Time frame: 12 weeks
Anthropometry 1: - Bioimpedance (in some centers) 1
Time frame: 12 weeks
Anthropometry 2: - Bioimpedance (in some centers) 1
Time frame: 12 weeks
Biomarkers>> a.1 Inflammation markers (pg/ml or ng/ml):
Time frame: 12 weeks
Biomarkers>> a.2 Inflammation markers (pg/ml or ng/ml):
Time frame: 12 weeks
Biomarkers>> a.3 Inflammation markers (pg/ml or ng/ml):
Time frame: 12 weeks
Biomarkers>> a.4 Inflammation markers (pg/ml or ng/ml):
Time frame: 12 weeks
Biomarkers>> a.5 Inflammation markers (pg/ml or ng/ml):
Time frame: 12 weeks
Biomarkers>> a.6 Inflammation markers (pg/ml or ng/ml):
Time frame: 12 weeks
Biomarkers>> b.1 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):
Time frame: 12 weeks
Biomarkers>> b.2 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):
Time frame: 12 weeks
Biomarkers>> b.3 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):
Time frame: 12 weeks
Biomarkers>> b.4 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):
Time frame: 12 weeks
Biomarkers>> c. Hematological (AU):
Time frame: 12 weeks
Functional assessment and frailty: - Steep Ramp test (A)
Time frame: 12 weeks
Functional assessment and frailty: - Steep Ramp test (B)
Time frame: 12 weeks
Functional assessment and frailty: - Steep Ramp test (C)
Time frame: 12 weeks
Functional assessment and frailty: - Frailty
Time frame: 12 weeks
Functional assessment and frailty: - Dynamic balance:
Time frame: 12 weeks
Functional assessment and frailty: - Physical activity: 1.Accelerometry
Time frame: 12 weeks
Functional assessment and frailty: - Physical activity: 2. Accelerometry
Time frame: 12 weeks
Functional assessment and frailty: - Physical activity: 3. Accelerometry
Time frame: 12 weeks
Functional assessment and frailty: - Physical activity: 4. Accelerometry
Time frame: 12 weeks
Patient-reported outcomes (PRO): -Fatigue:
Time frame: 12 weeks
Patient-reported outcomes (PRO): - Quality of life:
Time frame: 12 weeks
Patient-reported outcomes (PRO): - Nutrition:
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Derived from this study: PubMed 41352214Garcia-Garcia J, Rodriguez-Larrad A, de Rituerto Zeberio MM, Mediavilla JG, Vicente BL, Artola NT, Etxetxipia IZ, Garmendia I, Alberro A, Otaegui D, Borrego F, 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. 2026 Mar;17(2):102818. doi: 10.1016/j.jgo.2025.102818. Epub 2025 Dec 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise in people with Oncology and Solid Tumor, Adult, run by Biogipuzkoa Health Research Institute at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05131113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.