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

NCT07341698 — Not applicable, Recruiting, 110 participants, Copenhagen University Hospital, Rigshospitalet

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

RegistryNCT07341698, acronym PrepAllo
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment110 (Estimated)
SponsorCopenhagen University Hospital, Rigshospitalet (Other); collaborators: Aarhus University Hospital
ConditionsAllogeneic Hematopoietic Stem Cell Transplantation Recipient
InterventionsResistance training, Nutritional Support, Usual care (Other, dietary supplement, procedure)
Datesstart 2026-01-12, primary completion 2028-01-12 (estimated), completion 2032-10-12 (estimated), first posted 2026-01-14, last updated 2026-01-29
Locations1 site in Denmark

Related Papers Related Patents Related Grants Related Experts
All trials for Allogeneic Hematopoietic Stem Cell Transplantation Recipient All trials of Resistance training All trials of Nutritional Support

-Summary

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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Usual careActive comparatorProcedure: Usual careThe usual care group will receive standard care, including physio- and occupational therapy if admitted to the hospital, and potentially referral to rehabilitation in the municipality three months after transplantation.
Usual care plus the prehabilitation interventionExperimentalOther: Resistance training; Dietary Supplement: Nutritional Support; Procedure: Usual careThe prehabilitation group will in addition to usual care receive supervised individually tailored resistance training and optimized nutritional support
  • Resistance training (Other), also known as Exercise, Prehabilitation: Structured and supervised, group-based, resistance training 3x per week (individually tailored to the individual's capabilities)
  • Nutritional Support (Dietary supplement), also known as Prehabilitation, dietary counseling, nutrition: Optimized dietary counseling and supplementation to optimize nutritional intake
  • Usual care (Procedure), also known as HSCT, allogeneic hematopoietic stem cell transplantation, hematopoietic stem cell transplantation: Usual care is the standard care before allogeneic hematopoietic stem cell transplantation

+Outcome measures

Primary outcomes

  • 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) [From enrollment to 90 days post-transplantation]: HRQoL measured using EORCT-C30v3.0. Scores are from 0 to 100 with lower scores meaning poorer quality of life and high scores meaning better overall quality of life.

Secondary outcomes

  • Hospitalization [From enrollment to 90 days post-transplantation]: Days of hospitalization
  • Appendicular lean mass [From enrollment to 90 days post-transplantation]: Measured using dual-energy X-ray absorptiometry (DXA)
  • Appendicular Lean Mass Index [From enrollment to 90 days post-transplantation]: To account for body size, ALM is divided by height squared
  • Hand grip strength [From enrollment to 90 days post-transplantation.]: Using a handheld electronical dynamometer
  • Lower limb strength [From enrollment to 90 days post-transplantation.]: 5-repetition Sit-to-stand Test
  • Lower limb strength and endurance [From enrollment to 90 days post-transplantation.]: 30-second Sit-to-stand Test
  • Leg Extensor Power [From enrollment to 90 days post-transplantation]: Measured using a Nottingham Power Rig,

Other outcomes

  • Habitual gait speed [From enrollment to 90 days post transplantation]: 10-Meter walk test: Time to walk 10 meter distance at a preferred speed
  • Physical activity monitoring monitored with the use og SENS motion wearable activity sensors. Outcome will be reported in metabolic equivalents (METS) [From enrollment to 90 days post-transplantation]: Moderate to Vigorous Physical Activity (MVPA) will be measured with algorithms from the use of SENS motion wearables
  • Physical activity monitoring [From enrollment to 90 days post-transplantation]: Daily steps
  • Self reported physical activity [From enrollment to 90 days post-transplantation]: International Physical Activity Questionnaire short form (IPAQ-sf)
  • Karnofsky Performance Status [From enrollment to 90 days after transplantation]: Changes in Karnofsky Performance Status. Minimum value is 0 and maximum value is 100. A score of 100 equals normal function in performing daily activities while a score of 0 is equal to death. Thus, the lower scores the poorer performance of daily activities.
  • Symptoms of anxiety using Hospital Anxiety and Depression Scale (HADS) [From enrollment to 90 days post-transplantation]: Symptoms of anxiety measured using HADS. The item is separated in two parts. One is scoring anxiety level and one is scoring depression level. The minimum value is 0 while the maximum for each scale is 21 for each scale (21 for anxiety and 21 for depression). The higher score the more severe symptoms of either anxiety or depression. Scores above 11 in each category is considered to be moderate to severe symptoms with action needed to be taken on the condition.
  • Symptoms of depression using Hospital Anxiety and Depression Scale (HADS) [From enrollment to 90 days post-transplantation]: Symptoms of depression measured using HADS. Symptoms of anxiety measured using HADS. The item is separated in two parts. One is scoring anxiety level and one is scoring depression level. The minimum value is 0 while the maximum for each scale is 21 for each scale (21 for anxiety and 21 for depression). The higher score the more severe symptoms of either anxiety or depression. Scores above 11 in each category is considered to be moderate to severe symptoms with action needed to be taken on the condition.
  • Health literacy mesured using the Health Literacy Questionnaire (HLQ). [From enrollment to 90 days post-transplantation]: Health literacy was assessed using the Health Literacy Questionnaire (HLQ). The HLQ comprises nine independent scales scored as the mean of their constituent items. Scales 1-5 are scored from 1 to 4, and scales 6-9 from 1 to 5, with higher scores indicating better health literacy.
  • Days of hospitalization [From enrollment to 90 days and 1, 3 and 5 years after transplantation]: Days of hospitalization
  • Survival [1, 3 and 5 years after transplantation]: All-course survival with-out progression or relapse
  • Interviews [Participants will be asked to participate in interviews at time for recruitment (6-8 weeks before transplantation), at end of interventionperiod (day -7 to 0 before transplantation) and after last follow-up tests at day +90 after transplantation.]: Participants will be asked to participate in interviews during the study period
  • Complete remission [at day +90 and 1,3 and 5 years after transplantation]: Complete remission objective measured and evaluated by responsible physician. Complete remission is defined as full donor dhimerism if >95 % of bone marrow cells measured from chimerism is from donor.
  • Cancer Progression [At 1, 3 and 5 years after transplantation]: Progression of the underlying hematologic malignancy will be defined as objective worsening of disease burden after transplantation among patients who have not achieved complete remission after HSCT
  • Cancer recurrence [1,3 and 5 years after transplantation]: Recurrence (relapse) will be defined as reappearance of the original hematologic malignancy in a patient who has previously achieved complete remission after HSCT
  • Exercise habits [1,3 and 5 years after transplantation]: Exercise habits rapported by International Physical Activity Questionnaire (IPAQ)
  • Secondary malignancy [At 1, 3 and 5 years after transplantation]: Secondary malignancy will be defined as the occurrence of any new hematologic or solid malignant disease after HSCT that is genetically or clinically distinct from the primary malignancy for which the transplant was performed.
  • Engraftment [From enrollment to 90 days after transplantation]: Time from transplantation to first of three following days with absolute neutrophiles >0,5 x10\^9 /L
  • Transfusion need [From day 0 to day 90]: Days after transplantation with being independent of bloodtransfusions
  • Acute GvHD [Development of > grade 2 Acute GvHD from day 0 to day 90]: Development of Acute GvHD

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Copenhagen University Hospital - RigshospitaletCopenhagen, DenmarkDenmarkRecruiting