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Choroidal melanoma (CM) is one of the most common intraocular cancers worldwide. During treatment with episcleral brachytherapy, patients require a week of hospitalization in isolation. The primary aim of this study will be to investigate the effects of resistance training during hospitalization on health-related blood biomarkers in CM patients. Our secondary aim will be to assess changes in physical function tests, quality of life and anxiety and depression. Candidates for this study will be patients undergoing CM treatment at the "Hospital Universitari i Politècnic La Fe" of Valencia.
Candidates of the present study will be adults with CM diagnose and treated with plaque brachytherapy undergoing in "Hospital Universitari i Politècnic La Fe" (Valencia). All the participants will be informed about the objectives and content of the investigation and written informed consent will be obtained. Participants will be excluded if they (1) present a health status that forbids high intensity resistance training, (2) have any unsteady cardiac illness, (3) have serious metabolic disorder or if (4) they have any important orthopaedic disorder impeding exercise. The study will conform to the Declaration of Helsinki and will be approved by the Ethical Committee of "Hospital Universitari i Politècnic de La Fe".
A randomized controlled trial with two parallel groups is planned: a control group following the hospital's standard protocol (usual care) and an intervention group in which patients will complete a daily resistance training session during hospitalization. During the 5-7 days of treatment, where participants are going to be isolated in a room without human contact, are going to perform a daily session of exercise during about 30 minutes. The exercises will be supervised by a trained physician. To carry out the training session, elastic resistance bands will be used. On each day, each exercise will start with 3 sets of two repetitions as a warm-up and to calculate the appropriate intensity. The intensity will be that at which the patient reports a perceived exertion of 5-6 of 10 at the Borg CR10 scale after two repetitions. For each exercise, one set will be completed until task failure is achieved.If in any of the exercises the patient perceives this intensity only with the weight of his own limb or body weight, the exercise will be performed without elastic bands.
To observe the effects of the intervention, various blood tests, functional, quality-of-life and anxiety and depression assessments will be conducted before and after the program, as well as one-month post-hospital discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention Group | Experimental | Participants on this group will follow the exercise intervention mentioned in the protocol. |
|
| Control Group | No Intervention | Patients in the control group will follow the hospital's conventional protocol during the hospitalization days, which consists in isolated bed rest. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | Daily session during hospitalization. To carry out the training session, elastic bands (TheraBand CLX Consecutive Loops; TheraBand, Akron, OH) with resistance graded from very low to very high (i.e, yellow, red, green, blue, black, silver and gold) will be used. On each day, each exercise will start with 3 sets of two repetitions as a warm-up and to calculate the appropriate intensity. The intensity will be that at which the patient reports a perceived exertion of 5-6 of 10 at the Borg CR10 scale after two repetitions. For each exercise, one set will be completed until task failure is achieved.If in any of the exercises the patient perceives this intensity only with the weight of his own limb or body weight, the exercise will be performed without elastic bands. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood biomarkers: glucose | Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: urea | Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: creatinine | Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: glomerular filtration | Metabolic and lipidic response marker measured in milliliters/minutes/1,73 (ml/min/1,73). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: total bilirubin | Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: aspartate aminotransferase | Metabolic and lipidic response marker measured in units/liter (U/L). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| EORTC_C30 | The patient self-reported outcomes comprised the EORTC_ C30 questionnaire. This survey assesses various dimensions of quality of life. | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| EORTC_OPT30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari i Politècnic de La Fe | Recruiting | Valencia | Spain | 46026 | Spain |
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| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Blood biomarkers: alanine aminotransferase | Metabolic and lipidic response marker measured in units/liter (U/L). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: alkaline phosphatase | Metabolic and lipidic response marker measured in units/liter (U/L). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: lactate dehydrogenase | Metabolic and lipidic response marker measured in units/liter (U/L). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: creatine kinase | Metabolic and lipidic response marker measured in units/liter (U/L). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: total proteins | Metabolic and lipidic response marker measured in grams/deciliter (g/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: albumin | Metabolic and lipidic response marker measured in grams/deciliter (g/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: C-reactive protein | Inflammatory response marker measured in milligrams/liter (mg/L). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: interleukin 6 | Inflammatory response marker measured in picograms/milliliter (pg/ml). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: calcium | Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: albumine-corrected calcium | Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: chloride | Metabolic and lipidic response marker measured in milliequivalents/liter (mEq/L). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: sodium | Metabolic and lipidic response marker measured in milliequivalents/liter (mEq/L). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: potassium | Metabolic and lipidic response marker measured in milliequivalents/liter (mEq/L). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: total cholesterol | Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: HDL cholesterol | Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: LDL cholesterol | Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: no HDL cholesterol | Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: triglycerides | Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: hematies | Blood marker measured in x10^6/microliter (x10^6/µL). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: hemoglobin | Blood marker measured in grams/deciliter (g/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: hematocrit | Blood marker measured in percentage (%). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: mean corpuscular volume | Blood marker measured in femtoliters (fL). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: mean corpuscular hemoglobine | Blood marker measured in picograms (pg). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: mean corpuscular hemoglobin concentration | Blood marker measured in grams/deciliter (g/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: red cell distribution width - standard deviation | Blood marker measured in femtoliters (fL). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: red cell distribution width - coefficient of variation | Blood marker measured in percentage (%). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: erythroblasts | Blood marker measured in percentage (%). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: leukocytes | Blood marker measured in x10^3/microliter (x10^3/µL). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: neutrophils | Blood marker measured in x10^3/microliter (x10^3/µL). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: lymphocytes | Blood marker measured in x10^3/microliter (x10^3/µL). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: monocytes | Blood marker measured in x10^3/microliter (x10^3/µL). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: eosinophils | Blood marker measured in x10^3/microliter (x10^3/µL). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: basophils | Blood marker measured in x10^3/microliter (x10^3/µL). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: neutrophils % | Blood marker measured in percentage (%). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: lymphocytes % | Blood marker measured in percentage (%). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: monocytes % | Blood marker measured in percentage (%). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: eosinophils % | Blood marker measured in percentage (%). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: basophils % | Blood marker measured in percentage (%). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: immature granulocytes % | Blood marker measured in percentage (%). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: platelets | Blood marker measured in x10^3/microliter (x10^3/µL). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: mean platelet volume | Blood marker measured in femtoliters (fL). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: platelet distribution width | Blood marker measured in femtoliters (fL). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: platelet large cell ratio | Blood marker measured in percentage (%). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: prothrombin time | Blood marker measured in seconds (sec). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: prothrombin time ratio | Blood marker. | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: Quick index | Blood marker measured in percentage (%). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: activated partial thromboplastin time | Blood marker measured in seconds (sec). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: activated partial thromboplastin time ratio | Blood marker. | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: derived fibrinogen | Blood marker measured in milligrams/deciliter (mg/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: procalcitonin | Inflammatory response markers measured in nanograms/milliliter (ng/ml). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: glycated hemoblobin A1c | Metabolic and lipidic response marker measured in percentage (%). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: estimated average glucose | Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: carcinoembryonic antigen | Tumor marker measured in nanograms per milliliter (ng/ml). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Blood biomarkers: S-100 | Tumor markers measured in micrograms per liter (µg/L). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
The patient self-reported outcomes comprised also the complementary EORTC_ OPT30 module specifically designed for patients with eye cancer. This survey assesses various dimensions of quality of life, and the OPT30 module has a particular focus on evaluating visual functioning limitations. |
| At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| HADS questionnaire | The Hospital Anxiety and Depression Scale (HADS) will be used to measure symptoms of anxiety (HADS Anxiety) and depression (HADS Depression). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| Physical activity levels | The patients will be also asked about their levels of physical activity prior to hospitalization (minutes/week during the last month). | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| TUG test | To evaluate agility/coordination, the timed-up-and-go-test (TUG) will be used to, which consists of rising from a chair on command, walking a distance of 3 m, turning around, and walking back to the chair as fast as possible. | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| 30s StS Test | To assess muscle strength of lower limbs (endurance strength), the patient will be performed the 30-s sit-to-stand test (30 s StS), which is to stand up and sit down as many times as possible in 30 s. | At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge. |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |