Resistance Exercise in Patients With Ocular Melanoma

Not Applicable

Recruiting

• Conditions: Ocular Melanoma

• Registration Number: NCT06970236
• Lead Sponsor: University of Valencia

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2025-02-01
• Study First Submitted: 2025-03-27
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-08
• Study First Posted: 2025-05-14
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-28
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adults with Choroidal Melanoma diagnose and treated with plaque brachytherapy undergoing in "Hospital Universitari i Politècnic La Fe" (Valencia).

Exclusion Criteria

• Present a health status that forbids high intensity resistance training.
• Have any unsteady cardiac illness.
• Have serious metabolic disorder.
• Have any important orthopaedic disorder impeding exercise.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood biomarkers: mean corpuscular hemoglobine	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in picograms (pg).
Blood biomarkers: platelet large cell ratio	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in percentage (%).
Blood biomarkers: creatinine	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: alanine aminotransferase	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in units/liter (U/L).
Blood biomarkers: glomerular filtration	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in milliliters/minutes/1,73 (ml/min/1,73).
Blood biomarkers: total bilirubin	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: total proteins	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in grams/deciliter (g/dl).
Blood biomarkers: aspartate aminotransferase	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in units/liter (U/L).
Blood biomarkers: alkaline phosphatase	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in units/liter (U/L).
Blood biomarkers: lactate dehydrogenase	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in units/liter (U/L).
Blood biomarkers: creatine kinase	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in units/liter (U/L).
Blood biomarkers: albumin	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in grams/deciliter (g/dl).
Blood biomarkers: C-reactive protein	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Inflammatory response marker measured in milligrams/liter (mg/L).
Blood biomarkers: interleukin 6	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Inflammatory response marker measured in picograms/milliliter (pg/ml).
Blood biomarkers: LDL cholesterol	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: no HDL cholesterol	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: triglycerides	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: hematies	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in x10\^6/microliter (x10\^6/µL).
Blood biomarkers: hemoglobin	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in grams/deciliter (g/dl).
Blood biomarkers: hematocrit	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in percentage (%).
Blood biomarkers: mean corpuscular volume	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in femtoliters (fL).
Blood biomarkers: mean corpuscular hemoglobin concentration	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in grams/deciliter (g/dl).
Blood biomarkers: red cell distribution width - standard deviation	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in femtoliters (fL).
Blood biomarkers: red cell distribution width - coefficient of variation	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in percentage (%).
Blood biomarkers: erythroblasts	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in percentage (%).
Blood biomarkers: leukocytes	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in x10\^3/microliter (x10\^3/µL).
Blood biomarkers: neutrophils	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in x10\^3/microliter (x10\^3/µL).
Blood biomarkers: lymphocytes	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in x10\^3/microliter (x10\^3/µL).
Blood biomarkers: monocytes	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in x10\^3/microliter (x10\^3/µL).
Blood biomarkers: eosinophils	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in x10\^3/microliter (x10\^3/µL).
Blood biomarkers: basophils	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in x10\^3/microliter (x10\^3/µL).
Blood biomarkers: neutrophils %	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in percentage (%).
Blood biomarkers: lymphocytes %	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in percentage (%).
Blood biomarkers: monocytes %	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in percentage (%).
Blood biomarkers: eosinophils %	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in percentage (%).
Blood biomarkers: basophils %	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in percentage (%).
Blood biomarkers: immature granulocytes %	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in percentage (%).
Blood biomarkers: platelets	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in x10\^3/microliter (x10\^3/µL).
Blood biomarkers: mean platelet volume	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in femtoliters (fL).
Blood biomarkers: platelet distribution width	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in femtoliters (fL).
Blood biomarkers: prothrombin time	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in seconds (sec).
Blood biomarkers: prothrombin time ratio	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker.
Blood biomarkers: Quick index	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in percentage (%).
Blood biomarkers: activated partial thromboplastin time	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in seconds (sec).
Blood biomarkers: activated partial thromboplastin time ratio	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker.
Blood biomarkers: derived fibrinogen	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Blood marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: procalcitonin	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Inflammatory response markers measured in nanograms/milliliter (ng/ml).
Blood biomarkers: glycated hemoblobin A1c	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in percentage (%).
Blood biomarkers: estimated average glucose	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: carcinoembryonic antigen	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Tumor marker measured in nanograms per milliliter (ng/ml).
Blood biomarkers: S-100	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Tumor markers measured in micrograms per liter (µg/L).
Blood biomarkers: glucose	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: urea	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: calcium	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: albumine-corrected calcium	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: chloride	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in milliequivalents/liter (mEq/L).
Blood biomarkers: sodium	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in milliequivalents/liter (mEq/L).
Blood biomarkers: potassium	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in milliequivalents/liter (mEq/L).
Blood biomarkers: total cholesterol	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: HDL cholesterol	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).

Secondary Outcome Measures

Name	Time	Method
TUG test	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	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.
EORTC_C30	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	The patient self-reported outcomes comprised the EORTC_ C30 questionnaire. This survey assesses various dimensions of quality of life.
EORTC_OPT30	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.
HADS questionnaire	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	The Hospital Anxiety and Depression Scale (HADS) will be used to measure symptoms of anxiety (HADS Anxiety) and depression (HADS Depression).
Physical activity levels	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	The patients will be also asked about their levels of physical activity prior to hospitalization (minutes/week during the last month).
30s StS Test	At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.	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.

Trial Locations

Locations (1)

Hospital Universitari i Politècnic de La Fe; 🇪🇸 Valencia, Spain