Cancer Survivors
Conditions
Keywords
cancer survivors, childhood cancer, exercise, bone health, physical fitness, sarcopenia, physiological frailty, mental health, health-related quality of life, pQCT
Brief summary
Childhood cancer is a rare disease but a significant cause of death in children and adolescents. The incidence of childhood cancer is 1case per 300 cases of adult cancer, but surviving to it has important sequels. Endocrine dysfunction represents one of the most common issues in paediatric cancer survivors and impairs bone mineral density later in life. Some forms of exercise have been recommended to preserve bone health in healthy adults; however, its effect has not been properly studied yet in adult survivors of paediatric cancer using cutting-edge technologies, such as peripheral quantitative computed tomography (pQCT). As general aim, the 3D-BONE study will assess for the first time the effect of a live and online exercise programme on bone parameters and bone metabolism in adult survivors of paediatric cancer. This multicenter randomized controlled trial will be performed in three Andalusian provinces (Granada, Cordoba and Almeria). A minimum of 116 adult survivors of paediatric cancer aged 18 to 55 years will be recruited following the inclusion and exclusion criteria. They will be randomized (based on sex and age) into an INTERVENTION (n=58) or CONTROL group (n=58). The intervention group will receive a 6-month live and online exercise program based on progressive resistance and impact loading training that will be delivered by qualified professionals using a telehealth mobile app (3D-BONE app). Moreover, behaviour change techniques will be implemented in order to increase motivation and adherence to the program. This group will also receive diet counselling on calcium and vitamin so the difference between the groups is the exercise programme. Participants will be assessed before and after the intervention at the facilities of the Sport and Health University Research Institute (iMUDS) of the University of Granada. An in-depth analysis of bone parameters will be carried out using cutting-edge technologies, such as the pQCT (to analyse cortical and trabecular bone in 3 dimensions), dual-energy X-ray absorptiometry (DXA), hip and lumbar spine geometry outcomes. Moreover, a complete blood count will be obtained and markers of bone metabolism will be measured (B-CTX, PINP), including novel markers such as sclerostin and irisin which have recently been linked to human bone. Data will also be collected in anthropometry and body composition to obtain cardiovascular risk factors, sarcopenia and physiologic frailty risk factors, mental health, health-related quality of life and objective measures of physical activity and fitness. This will ensure obtaining novel, precise and strong data in this population.
Interventions
BEHAVIORALProgressive resistance training plus impact loading
The intervention will be performed 3 days a week (Monday, Tuesday and Thursday \[group 1\] and Monday, Wednesday and Thursday \[group 2\]), following previous studies. Each section will last 45 minutes, comprising 10 minutes of warm-up, 20 minutes of resistance training, 10 minutes of impact exercises, and 5 minutes of cool down. There will always be a minimum of 24-hour interval between exercise sessions, and an extra training day (Friday) will be available if participants miss a training day in the respective week. The exercise periodisation will be composed by 3 phases (phase 1, phase 2 and phase 3). Across phases, training volume will vary and a progressively increase in exercise intensity will be applied in each phase. The three phases of the study will consist of 8 weeks, and within each phase the participants will perform six different training sessions.
Sponsors
Universidad de Granada
Loyola University
University of Thessaly
Hospital Materno-Infantil Torrecárdenas de Almería
Hospital Universitario Reina Sofia de Cordoba
University Hospital Virgen de las Nieves
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Prior diagnosis of pediatric cancer and history of receiving treatment (radiation therapy and/or chemotherapy). * 18-55 years of age at recruitment
Exclusion criteria
* Participation in another research study simultaneously. * Not currently receiving cancer treatment. * Previous diagnosed anorexia/bulimia, known pregnancy, known alcohol or drug abuse. * Requiring chronic oral glucocorticoid therapy. * Having an injury that may affect daily life activities and can be aggravated by exercise.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cortical and Trabecular Volumetric Bone Mineral Density (pQCT) | Baseline and 6 months | Cortical and trabecular BMD will be measured at tibia and radius using pQCT (mg/cm³). |
| Change in Cortical Bone Thickness (pQCT) | Baseline and 6 months | Cortical bone thickness at tibia and radius (mm) will be derived from pQCT images. |
| Change in Periosteal and Endocortical Circumference (pQCT) | Baseline and 6 months | Periosteal and endocortical circumference at tibia and radius will be measured via pQCT (mm) |
| Change in Cross-Sectional Moment of Inertia-CSMI (pQCT) | Baseline and 6 months | CSMI at tibia and radius will be calculated to assess structural bone strength (mm⁴). |
| Change in Bone strehgth indices (pQCT) | Baseline and 6 months | Bone strehgth indices at tibia and radius will be obtained from pQCT images |
| Change in Bone Mineral Content (DXA) | Baseline and 6 months | BMC will be assessed using DXA at whole-body and regional sites (g) |
| Change in Areal Bone Mineral Density (DXA) | Baseline and 6 months | Areal BMD will be measured with DXA at whole-body and regional sites (g/cm²) |
| Change in Cross-Sectional Area (DXA-HSA) | Baseline and 6 months | Derived from hip structural analysis (mm²). |
| Change in Section Modulus (DXA-HSA) | Baseline and 6 months | Indicates bone strength; calculated from HSA (mm³). |
| Change in Cross-Sectional Moment of Inertia (DXA-HSA) | Baseline and 6 months | Assesses resistance to bending forces (mm⁴). |
| Change in Trabecular Bone Score (TBS) | Baseline and 6 months | Lumbar spine texture will be assessed using TBS (TBS index). |
| Change in Serum Lipid Profile | Baseline and 6 months | Cholesterol, triglycerides, HDL, LDL levels (mg/dL). |
| Change in Total bilirubin | Baseline and 6 months | mg/dL |
| Change in Calcium | Baseline and 6 months | mg/dL |
| Change in Creatinine | Baseline and 6 months | mg/dL |
| Change in Phosphorus | Baseline and 6 months | mg/dL |
| Change in Glucose | Baseline and 6 months | mg/dL |
| Change in Magnesium | Baseline and 6 months | mg/dL |
| Change in Uric acid | Baseline and 6 months | mg/dL |
| Change in ALT/GPT | Baseline and 6 months | U/L |
| Change in Na/K/Cl | Baseline and 6 months | mEq/L |
| Change in Albumin | Baseline and 6 months | g/dL |
| Change in Total protein | Baseline and 6 months | g/dL |
| Change in Serum 25(OH) Vitamin D | Baseline and 6 months | ng/mL |
| Change in Alkaline phosphatase | Baseline and 6 months | U/L |
| Change in Bone specific alkaline phosphatase | Baseline and 6 months | ng/mL |
| Change in Glycosylated hemoglobin | Baseline and 6 months | mmol/mol |
| Change in Parathyrin | Baseline and 6 months | pg/mL |
| Change in Thyrotropin | Baseline and 6 months | µUI/mL |
| Change in Gamma-glutamyl transferase | Baseline and 6 months | U/L |
| Change in β-CTX (Serum) | Baseline and 6 months | Marker of bone resorption (ng/mL) |
| Change in PINP (Serum) | Baseline and 6 months | Marker of bone formation (ng/mL) |
| Change in Irisin (Serum) | Baseline and 6 months | ng/mL |
| Change in Sclerostin (Serum) | Baseline and 6 months | ng/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass | Baseline and 6 months | Measured with electronic scale (kg). |
| Change in Height | Baseline and 6 months | Measured with stadiometer (cm). |
| Change in Body Mass Index (BMI) | Baseline and 6 months | Calculated as kg/m². |
| Change in Blood Pressure | Baseline and 6 months | Systolic and diastolic pressure measured in mmHg. |
| Change in body circumferences | Baseline and 6 months | Waist, hip and neck circumferences measured in cm. |
| Change in Lean Soft Tissue Mass (DXA) | Baseline and 6 months | Assessed at whole-body using DXA (g). |
| Change in Fat Mass (DXA) | Baseline and 6 months | Assessed at whole-body using DXA (kg). |
| Change in Body Fat Percentage (DXA) | Baseline and 6 months | Assessed at whole-body using DXA (%). |
| Change in 6-Minute Walk Test | Baseline and 6 months | Distance walked in 6 minutes (meters). |
| Change in Squat Jump Test | Baseline and 6 months | Height achieved in the test (cm). |
| Change in Handgrip Strength Test | Baseline and 6 months | Maximal grip force (kg). |
| Change in Standing Long Jump Test | Baseline and 6 months | Distance achieved in the test (cm). |
| Change in 5 Times Sit-to-Stand Test | Baseline and 6 months | Time to complete 5 repetitions (seconds) |
| Change in 4-m Gait Speed Test | Baseline and 6 months | Time to walk 4 meters (seconds) |
| Change in Self-Reported Fitness (IFIS) | Baseline and 6 months | Perceived fitness using IFIS questionnaire. |
| Change in Sarcopenia Classification (EWGSOP2) | Baseline and 6 months | Sarcopenia will be classified as no, probable, or confirmed based on grip strength, sit-to-stand time, and appendicular lean mass by DXA. Categorical (no/probable/confirmed). |
| Change in Frailty Status | Baseline and 6 months | Frailty will be assessed using five criteria: low muscle mass, fatigue, low physical activity, slowness, and weakness. Categorical (frail/non-frail). |
| Change in Physical Activity and Sedentarism (Accelerometer) | Baseline and 6 months | Measured over 7 consecutive days using ActiGraph (counts per minute). |
| Change in Self-Reported Physical Activity (IPAQ) | Baseline and 6 months | Activity levels using the IPAQ (MET-min/week) |
| Change in Bone-Specific Physical Activity (BPAQ) | Baseline and 6 months | Scored from the BPAQ questionnaire (BPAQ score) |
| Change in Calcium Intake | Baseline and 6 months | Estimated using validated short calcium questionnaire (mg/day). |
| Change in Vitamin D Intake | Baseline and 6 months | Estimated from dietary questionnaire (IU/day). |
| Change in Mediterranean Diet Adherence | Baseline and 6 months | Calculated from validated adherence questionnaire (Score 0-14) |
| Change in Quality of Life | Baseline and 6 months | HRQoL from the SF-36 questionnaire (0-100 scale). |
| Change in Anxiety and Depression (HADS) | Baseline and 6 months | Anxiety and depression score from HADS (Score 0-21) |
| Change in Self-Esteem (Rosenberg Scale) | Baseline and 6 months | Assessed using Rosenberg Self-Esteem Scale (Score 0-30) |
| Change in Perceived Stress (PSS) | Baseline and 6 months | Assessed via Perceived Stress Scale (Score 0-40). |
Countries
Spain
Contacts
CONTACTEsther Ubago Guisado, Ramón y Cajal researcher
CONTACTLuis Gracia Marco, Senior Lecturer
Outcome results
None listed