Resistance Exercise in Patients With Ocular Melanoma

NCT06970236 | Recruiting DMC

• 1 other identifier: IHOPE-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Melanoma

Outcome Measures

Primary Outcomes (60)

• 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.

• 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.

Secondary Outcomes (6)

• EORTC_C30

  At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.

• EORTC_OPT30

  At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.

• HADS questionnaire

  At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.

• Physical activity levels

  At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.

• TUG test

  At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.

Study Arms (2)

Exercise Intervention Group

EXPERIMENTAL

Participants on this group will follow the exercise intervention mentioned in the protocol.

Other: Exercise

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.

Interventions

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.

Exercise Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Hospital Universitari i Politècnic de La Fe

Valencia, Spain, 46026, Spain

RECRUITING

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Exercise

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: May 14, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)