An interventional study of Physical exercise in Oncology and Solid Tumor, Adult, sponsored by Biogipuzkoa Health Research Institute. Completed at 3 sites in Spain. Open to participants aged 70 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by Biogipuzkoa Health Research Institute · Not applicable, Interventional, and Supportive care
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 186 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Biogipuzkoa Health Research Institute is the lead sponsor of 15 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The control group will receive the usual care and hygiene recommendations of the movement
The interventional group will add an individualized physical exercise program to the usual care.
Other: Physical exercise
Physical exercise
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.
Time frame: 12 weeks
Integral Geriatric Assessment -Socio-familial situation:
Abbreviated Gijón Scale (3-15 pts)
Time frame: 12 weeks
Integral Geriatric Assessment - Basic Activities of Daily Living ( BADL):
Barthel Index (0-100 pts)
Time frame: 12 weeks
Integral Geriatric Assessment -Instrumental Activities of Daily Living (IADL):
Lawton´s test (0-8 pts)
Time frame: 12 weeks
Integral Geriatric Assessment -Cognitive function:
Pfeiffer test (0-10 pts)
Time frame: 12 weeks
Integral Geriatric Assessment - Depression:
Yesavage test-short form (0-15 pts) (Yes/No)
Time frame: 12 weeks
Integral Geriatric Assessment -Nutritional status:
MNA-SF test (0-14)
Time frame: 12 weeks
Integral Geriatric Assessment -Polypharmacy:
Number of chronic drugs consumed by the patient
Time frame: 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)
Time frame: 12 weeks
Integral Geriatric Assessment -Pain:
VAS (0-10 pts)
Time frame: 12 weeks
Integral Geriatric Assessment - Emotional distress:
Stress thermometer (0-10 pts)
Time frame: 12 weeks
Cognitive function
- Montreal Cognitive Assessment (MOCA) test (0-30 pts)
Time frame: 12 weeks
Anthropometry - Weight:
Unit of measure: kg
Time frame: 12 weeks
Anthropometry - Height:
Unit of measure: cm
Time frame: 12 weeks
Anthropometry -Waist, hip and calf circumference:
Unit of measure: cm
Time frame: 12 weeks
Anthropometry -Blood pressure:
- Unit of measure: mmHg
Time frame: 12 weeks
Anthropometry 1: - Bioimpedance (in some centers) 1
· Resistance (Ω)
Time frame: 12 weeks
Anthropometry 2: - Bioimpedance (in some centers) 1
· Phase angle (º)
Time frame: 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).
Time frame: 12 weeks
Biomarkers>> a.2 Inflammation markers (pg/ml or ng/ml):
- Tumor necrosis factor alpha (TNFa)
Time frame: 12 weeks
Biomarkers>> a.3 Inflammation markers (pg/ml or ng/ml):
- Interferon gamma (IFN)
Time frame: 12 weeks
Biomarkers>> a.4 Inflammation markers (pg/ml or ng/ml):
- C-reactive protein (CRP)
Time frame: 12 weeks
Biomarkers>> a.5 Inflammation markers (pg/ml or ng/ml):
- Brain-derived neurotrophic factor (BDNF)
Time frame: 12 weeks
Biomarkers>> a.6 Inflammation markers (pg/ml or ng/ml):
- CMV serology
Time frame: 12 weeks
Biomarkers>> b.1 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):
- Insulin-derived growth factor (IGF-1).
Time frame: 12 weeks
Biomarkers>> b.2 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):
- Dehydroepiandrosterone sulfate (DHEA sulfate)
Time frame: 12 weeks
Biomarkers>> b.3 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):
- Vitamin D
Time frame: 12 weeks
Biomarkers>> b.4 Endocrine-nutritional and muscle wasting markers (pg/ml or ng/ml):
- Albumin
Time frame: 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).
Time frame: 12 weeks
Functional assessment and frailty: - Steep Ramp test (A)
\>Heart rate (bpm)
Time frame: 12 weeks
Functional assessment and frailty: - Steep Ramp test (B)
\>Time spent cycling (min/sec)
Time frame: 12 weeks
Functional assessment and frailty: - Steep Ramp test (C)
\> Maximum W
Time frame: 12 weeks
Functional assessment and frailty: - Frailty
G8 scale ( 0-17); Fried Frailty Phenotype (0-5 pts)
Time frame: 12 weeks
Functional assessment and frailty: - Dynamic balance:
8 Foot Up and Go Test (8FUGT) (sec)
Time frame: 12 weeks
Functional assessment and frailty: - Physical activity: 1.Accelerometry
Sleep efficiency (%)
Time frame: 12 weeks
Functional assessment and frailty: - Physical activity: 2. Accelerometry
Moderate too vigorous physical activity (min/d)
Time frame: 12 weeks
Functional assessment and frailty: - Physical activity: 3. Accelerometry
Sedentary time (h/d)
Time frame: 12 weeks
Functional assessment and frailty: - Physical activity: 4. Accelerometry
Light physical activity (min/d)
Time frame: 12 weeks
Patient-reported outcomes (PRO): -Fatigue:
EORTC QLQ-FA12
Time frame: 12 weeks
Patient-reported outcomes (PRO): - Quality of life:
EORTC QLQ-C30
Time frame: 12 weeks
Patient-reported outcomes (PRO): - Nutrition:
Simplified Nutritional Appetite Questionnire
Time frame: 12 weeks
Patient-reported outcomes (PRO): - Cognition:
Cognitive Failures Questionnaire
Time frame: 12 weeks
Patient-reported outcomes (PRO): - Physical activity:
Godin Physical Activity Questionnaire
Time frame: 12 weeks
Adverse events (CTCAE)
* Treatment discontinuation (Yes/ No) * Dose reduction (Yes/ No) * Percentage of treatment completed (Yes/ No) * Completion of treatment (Yes/ No)
Time frame: 12 weeks
Factors related to physical exercise adherence
Beliefs, barriers, facilitators and self-efficacy in relation to physical exercise ( self-developed questionnaire)
Time frame: 12 weeks
Intervention assessment - Follow-up of the intervention
Self- developed questionnaire
Time frame: 12 weeks
Intervention assessment - Adverse events associated with the intervention
Self- developed questionnaire
Time frame: 12 weeks
Intervention assessment - Satisfaction with the intervention
Self- developed questionnaire
Time frame: 12 weeks
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Biogipuzkoa Health Research Institute