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Recruiting NCT07341698

Prehabilitation for Patients Diagnosed With Blood Cancer and Treated With Al-logeneic Hematopoietic Stem Cell Transplantation

No phase Interventional Allogeneic Hematopoietic Stem Cell Transplantation Recipient

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Resistance training, Nutritional Support, Usual care.
Who it may be relevant to
Registry conditions: Allogeneic Hematopoietic Stem Cell Transplantation Recipient. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prehabilitation for Patients Diagnosed With Blood Cancer and Treated With Alloge-neic Hematopoietic Stem Cell Transplantation - a National Randomized Controlled Trial

Overview

Seventy-five percent of patients treated with hematopoietic stem cell transplants survive one-year post-transplantation. However, this intensive treatment is associated with prolonged hospitalizations and significant deconditioning. Pathophysiological changes in skeletal muscle mass and function have notable implications for disease progression and long-term prognosis. Patients frequently report substantial rehabilitation needs, though these needs are highly individualized and fluctuate over time, with musculoskeletal dysfunction and fa-tigue being the most common barriers to prehabilitation. Furthermore, at least 35% of cancer patients are found to have inadequate daily protein intake, which may hinder improve-ments in physical performance through prehabilitation. Several recent studies have demonstrated the safety and feasibility of exercise-based prehabilitation interventions during the pre-transplant period. However, no full-scale randomized controlled trial (RCT) has been conducted to date.

Detailed description

Evaluate the effectiveness of an individualized prehabilitation intervention in addition to usual care, compared to usual care alone on HRQoL, and secondary outcomes hospitalization, muscle mass and muscle function.

Interventions

  • Other Resistance training
    Structured and supervised, group-based, resistance training 3x per week (individually tailored to the individual's capabilities)
  • Dietary supplement Nutritional Support
    Optimized dietary counseling and supplementation to optimize nutritional intake
  • Procedure Usual care
    Usual care is the standard care before allogeneic hematopoietic stem cell transplantation

Primary outcome measures

  • Health-Related Quality of Life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core questionnaires with 30 questions (EORTC QLQ C-30) [Time frame: From enrollment to 90 days post-transplantation]
Secondary outcome measures (7)
  • Hospitalization [Time frame: From enrollment to 90 days post-transplantation]
  • Appendicular lean mass [Time frame: From enrollment to 90 days post-transplantation]
  • Appendicular Lean Mass Index [Time frame: From enrollment to 90 days post-transplantation]
  • Hand grip strength [Time frame: From enrollment to 90 days post-transplantation.]
  • Lower limb strength [Time frame: From enrollment to 90 days post-transplantation.]
  • Lower limb strength and endurance [Time frame: From enrollment to 90 days post-transplantation.]
  • Leg Extensor Power [Time frame: From enrollment to 90 days post-transplantation]

Eligibility criteria

Inclusion criteria

Adult patients >18 years will be eligible for inclusion if they are scheduled for a allo-HSCT with at least four weeks before their scheduled transplantation date.

Exclusion criteria

  • pregnancy
  • physical or mental disabilities precluding test of muscle function
  • inability to read and understand Danish or English

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Copenhagen University Hospital - Rigshospitalet — Copenhagen

Identifiers

NCT: NCT07341698 · H-25053677 · MS25-01447

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗