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NCT Number: NCT06970236

Resistance Exercise in Patients With Ocular Melanoma

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari i Politècnic de La Fe

Valencia, Spain, 46026

Location status: Recruiting

Location contact

Joaquín Calatayud

CONTACT

[email protected]

+34 625 577 509

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Blood biomarkers: glucose

    Time frame: 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).

  2. Blood biomarkers: urea

    Time frame: 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).

  3. Blood biomarkers: creatinine

    Time frame: 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).

  4. Blood biomarkers: glomerular filtration

    Time frame: 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).

  5. Blood biomarkers: total bilirubin

    Time frame: 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).

  6. Blood biomarkers: aspartate aminotransferase

    Time frame: 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).

  7. Blood biomarkers: alanine aminotransferase

    Time frame: 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).

  8. Blood biomarkers: alkaline phosphatase

    Time frame: 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).

  9. Blood biomarkers: lactate dehydrogenase

    Time frame: 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).

  10. Blood biomarkers: creatine kinase

    Time frame: 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).

  11. Blood biomarkers: total proteins

    Time frame: 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).

  12. Blood biomarkers: albumin

    Time frame: 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).

  13. Blood biomarkers: C-reactive protein

    Time frame: 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).

  14. Blood biomarkers: interleukin 6

    Time frame: 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).

  15. Blood biomarkers: calcium

    Time frame: 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).

  16. Blood biomarkers: albumine-corrected calcium

    Time frame: 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).

  17. Blood biomarkers: chloride

    Time frame: 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).

  18. Blood biomarkers: sodium

    Time frame: 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).

  19. Blood biomarkers: potassium

    Time frame: 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).

  20. Blood biomarkers: total cholesterol

    Time frame: 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).

  21. Blood biomarkers: HDL cholesterol

    Time frame: 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).

  22. Blood biomarkers: LDL cholesterol

    Time frame: 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).

  23. Blood biomarkers: no HDL cholesterol

    Time frame: 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).

  24. Blood biomarkers: triglycerides

    Time frame: 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).

  25. Blood biomarkers: hematies

    Time frame: 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).

  26. Blood biomarkers: hemoglobin

    Time frame: 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).

  27. Blood biomarkers: hematocrit

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

    Blood marker measured in percentage (%).

  28. Blood biomarkers: mean corpuscular volume

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

    Blood marker measured in femtoliters (fL).

  29. Blood biomarkers: mean corpuscular hemoglobine

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

    Blood marker measured in picograms (pg).

  30. Blood biomarkers: mean corpuscular hemoglobin concentration

    Time frame: 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).

  31. Blood biomarkers: red cell distribution width - standard deviation

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

    Blood marker measured in femtoliters (fL).

  32. Blood biomarkers: red cell distribution width - coefficient of variation

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

    Blood marker measured in percentage (%).

  33. Blood biomarkers: erythroblasts

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

    Blood marker measured in percentage (%).

  34. Blood biomarkers: leukocytes

    Time frame: 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).

  35. Blood biomarkers: neutrophils

    Time frame: 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).

  36. Blood biomarkers: lymphocytes

    Time frame: 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).

  37. Blood biomarkers: monocytes

    Time frame: 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).

  38. Blood biomarkers: eosinophils

    Time frame: 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).

  39. Blood biomarkers: basophils

    Time frame: 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).

  40. Blood biomarkers: neutrophils %

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

    Blood marker measured in percentage (%).

  41. Blood biomarkers: lymphocytes %

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

    Blood marker measured in percentage (%).

  42. Blood biomarkers: monocytes %

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

    Blood marker measured in percentage (%).

  43. Blood biomarkers: eosinophils %

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

    Blood marker measured in percentage (%).

  44. Blood biomarkers: basophils %

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

    Blood marker measured in percentage (%).

  45. Blood biomarkers: immature granulocytes %

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

    Blood marker measured in percentage (%).

  46. Blood biomarkers: platelets

    Time frame: 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).

  47. Blood biomarkers: mean platelet volume

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

    Blood marker measured in femtoliters (fL).

  48. Blood biomarkers: platelet distribution width

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

    Blood marker measured in femtoliters (fL).

  49. Blood biomarkers: platelet large cell ratio

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

    Blood marker measured in percentage (%).

  50. Blood biomarkers: prothrombin time

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

    Blood marker measured in seconds (sec).

  51. Blood biomarkers: prothrombin time ratio

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

    Blood marker.

  52. Blood biomarkers: Quick index

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

    Blood marker measured in percentage (%).

  53. Blood biomarkers: activated partial thromboplastin time

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

    Blood marker measured in seconds (sec).

  54. Blood biomarkers: activated partial thromboplastin time ratio

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

    Blood marker.

  55. Blood biomarkers: derived fibrinogen

    Time frame: 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).

  56. Blood biomarkers: procalcitonin

    Time frame: 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).

  57. Blood biomarkers: glycated hemoblobin A1c

    Time frame: 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 (%).

  58. Blood biomarkers: estimated average glucose

    Time frame: 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).

  59. Blood biomarkers: carcinoembryonic antigen

    Time frame: 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).

  60. Blood biomarkers: S-100

    Time frame: 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).

Secondary outcomes

  1. EORTC_C30

    Time frame: 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.

  2. EORTC_OPT30

    Time frame: 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.

  3. HADS questionnaire

    Time frame: 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).

  4. Physical activity levels

    Time frame: 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).

  5. TUG test

    Time frame: 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.

  6. 30s StS Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Impact of an In-hospital Exercise Program on the Health of Patients With Ocular Melanoma Undergoing Plaque Brachytherapy: A Randomized Controlled Trial

Acronym: IHOPE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 14, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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