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NCT05023785Toboroz

The HIMALAYAS Trial and Lifestyle Changes in Pediatric, Adolescent and Young Adult Cancer Survivors Study: A Multicentre Randomized Controlled Trial

The Harmonized Interventions to Maintain Health Via Appropriate Risk Factor Modification and Lifestyle Changes in Pediatric, Adolescent and Young Adult Cancer Survivors Study: A Multicentre Randomized Controlled Trial

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. nov. 26.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

Pediatric, adolescent and young adult cancer survivors (PAYA-CS) are at higher risk of cardiovascular (CV) morbidity and mortality. This is a consequence of prior cancer-related therapies that have the potential of producing cardiac dysfunction, reducing cardiorespiratory fitness (reduced VO2peak) and psychosocial morbidities (i.e., anxiety and depression). A reduction of physical activity levels can evoke functional limitations resulting in a vicious cycle of reduced exercise tolerance and physical deterioration. To date, there is limited evidence on the use of non-pharmacological strategies such as Cardio-Oncology Rehabilitation (CORE) including structured exercise, behavioural support and risk factor management to improve the outcomes of this underserved population. The HIMALAYAS study is a randomized controlled trial designed to evaluate the impact of a CORE intervention (consisting of six-months home and onsite-based structured moderate to high-intensity aerobic exercise training and CVD risk factor management) on CV and psychosocial health, and the cardiovascular disease risk in PAYA-CS with mild heart dysfunction (stage B heart failure) compared to standard of care (i.e. providing guidance on the current exercise recommendations for cancer survivors). The primary objective of the HIMALAYAS study is to determine whether a six-month supervised CORE intervention, consisting of individualized moderate to high-intensity aerobic exercise training, CVD risk factor modification and enhanced online behavioral support, improves cardiorespiratory fitness (VO2peak; primary outcome), cardiac function, CVD risk factors and biomarkers, and patient-reported outcomes (PROs) at six- months follow-up compared to standard of care (CON) in PAYA-CS with stage B heart failure. The secondary objective is to assess the same outcomes at 12- and 24-months follow-up. We will recruit 336 patients across 5 sites in Canada and upto 134 patients at UHN in 3 years and conclude in 6 years.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
336 (tervezett)
Első benyújtás
2021. ápr. 29.
Kezdés
2024. jan. 1.
Elsődleges befejezés
2026. szept.
Fő szponzor
University Health Network, Toronto
NCT-szám
NCT05023785

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 336
  • 2024. jan. 1. és az elsődleges befejezés (2026. szept.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Laborértékek

  • Have established CVD (excluding mildly reduced LVEF as described above);

Egyéb

  • Have an absolute or unresolved relative contraindication to exercise according to the American College of Sports Medicine guidelines;
  • Have an untreated physical or mental health concern that precludes safe and effective exercise participation;
  • Be pregnant at time of recruitment;
  • Be currently engaging in frequent high-intensity exercise (>1 high-intensity exercise session per week);
  • Have substantial barriers to participating, including (1) living too far from study centre or (2) being unable or willing to comply with the study protocol.

Kiket keres a vizsgálat

  • Be a PAYA-CS, defined as ≤39 years of age at the time of cancer diagnosis;
  • Be 18-45 years of age at the time of enrolment;
  • Received cancer treatment(s) with known cardiovascular risks (e.g., anthracyclines, trastuzumab, radiotherapy, platinum-based agents, vascular endothelial growth factor inhibitors, tyrosine kinase inhibitors);
  • Be cancer-free at the time of enrollment;
  • Stage B Heart Failure (SBHF)
    • In patients with availability of pre-treatment imaging:
    • ≥10% decrease in LVEF at post-treatment compared to pre-treatment
    • ≥15% decrease in GLS at post-treatment compared to pre-treatment
    • No pre-treatment imaging:
    • LVEF ≤53% in women/51% in men
    • GLS >-18%
    • Left ventricular hypertrophy (LV mass/body surface area: >95 g/m2 for women or >115 g/m2 for men)
    • Concentric remodelling (>0.42 relative wall thickness)
    • Diastolic dysfunction (≥ grade 1)
    • BNP ≥35pg/ml or NT-proBNP ≥125pg/ml

Életkor a regiszterben: 18 év – 45 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
University Health NetworkTorontoKanadaToboroz

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