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Physical Activity and Exercise During Early Treatment Phases for Childhood Acute Lymphoblastic Leukaemia to Protect Against Muscle Loss and Improve Frailty Outcomes

Study acronym: PROTECT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria revised Secondary endpoints: details revised at 1 of 32 entriesv5 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 32 entries

    See this version in full on ClinicalTrials.gov ↗

  2. Study description shortened, about 2 wordsv4 See this version in full on ClinicalTrials.gov ↗
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 2026 to Feb 24, 2026 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Mar 2026 to Feb 24, 2026
    • Site details revised
  4. Start date: Jan 17, 2026 to Mar 2026 Primary endpoints revised (11) · Secondary endpoints: 27 to 32 · Study description expanded, about 34 wordsv2 Show 3 more changesShow less
    • Primary endpoints revised (11)
    • Secondary endpoints: 27 to 32
    • Study description expanded, about 34 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a small trial testing out a new approach before doing a bigger study. Researchers are observing a group of children/adolescents (ages 5-17) with acute lymphoblastic leukemia (ALL) and testing a physical activity and exercise program on a group of them who after 5 weeks of treatment show signs of weakness or frailty. Kids who are NOT losing muscle aren't part of the exercise trial - they're just monitored over time to see how they do. The goal: To see if an exercise program helps kids who are getting weaker from acute lymphoblastic leukemia treatment build back/maintain their strength, compared to kids who don't do the extra intervention. The study will also look at if this way of measuring muscle weakness works well for kids with cancer.
Trial Details
NCT Number NCT07325305
Lead Sponsor Murdoch Childrens Research Institute
Conditions Sarcopenia, Acute Lymphoblastic Leukemia
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov