Clinical trial NCT06970236: Resistance Exercise in Patients With Ocular Melanoma
Official title: Impact of an In-hospital Exercise Program on the Health of Patients With Ocular Melanoma Undergoing Plaque Brachytherapy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ocular Melanoma
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood biomarkers: glucose
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: urea
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: creatinine
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: glomerular filtration
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: total bilirubin
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: aspartate aminotransferase
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: alanine aminotransferase
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: alkaline phosphatase
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: lactate dehydrogenase
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: creatine kinase
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: total proteins
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: albumin
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: C-reactive protein
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: interleukin 6
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: calcium
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: albumine-corrected calcium
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: chloride
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: sodium
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: potassium
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: total cholesterol
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: HDL cholesterol
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: LDL cholesterol
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: no HDL cholesterol
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: triglycerides
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: hematies
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: hemoglobin
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: hematocrit
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: mean corpuscular volume
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: mean corpuscular hemoglobine
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: mean corpuscular hemoglobin concentration
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: red cell distribution width - standard deviation
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: red cell distribution width - coefficient of variation
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: erythroblasts
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: leukocytes
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: neutrophils
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: lymphocytes
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: monocytes
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: eosinophils
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: basophils
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: neutrophils %
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: lymphocytes %
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: monocytes %
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: eosinophils %
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: basophils %
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: immature granulocytes %
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: platelets
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: mean platelet volume
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: platelet distribution width
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: platelet large cell ratio
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: prothrombin time
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: prothrombin time ratio
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: Quick index
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: activated partial thromboplastin time
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: activated partial thromboplastin time ratio
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: derived fibrinogen
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: procalcitonin
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: glycated hemoblobin A1c
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: estimated average glucose
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: carcinoembryonic antigen
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Blood biomarkers: S-100
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Secondary outcomes:
measure: EORTC_C30
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: EORTC_OPT30
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: HADS questionnaire
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: Physical activity levels
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: TUG test
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
measure: 30s StS Test
timeFrame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic de La Fe
Study officials:
References: