Management of the australianclinicaltrials.gov.au website has been transferred from NHMRC to the Commonwealth Department of Health. Disruption to site users as a consequence of this change should be minimal. Users should note that email notifications coming from the website will come from australianclinicaltrials@health.gov.au from Friday the 8th of April 2022. Any user experiencing difficulty as a result of this change should direct enquiries to australianclinicaltrials@health.gov.au for assistance.

Clinical Trial Details

Prehabilitation to Improve outcomes afteR Autologous sTem cEll transplantation (PIRATE) – A randomised controlled trial

Print record Print record
Trial Information

Broad Health Condition Cancer
Cancer
Cancer
Cancer
Cancer
Cancer

Specific Health ConditionMyeloma
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Leukaemia - Acute leukaemia
Leukaemia - Chronic leukaemia
Hodgkin's

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Box Hill Hospital - Box Hill


Postcode
3128 - Box Hill

Anticipated date of first participant enrolment30/06/2020

Anticipated date of last participant enrolment30/06/2020

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

The purpose of this study is to see if providing rehabilitation (prehabilitation) before stem cell transplant builds physical strength and fitness.

Who is it for?
You may be eligible for this study if you are aged 18 of older and are on the waitlist for autologous stem cell transplant.

Study details
Participants will be randomised by chance (like flipping a coin) into two groups. One group will receive a physiotherapy assessment and standardised exercise advice in addition to standard care. The other group will attend 2 x 60 minute exercise classes per week and receive fortnightly phone calls comprising nutrition education for up to 8 weeks before their transplant. As part of this study, participants will also have a fitness and nutrition assessment, answer questionnaires, provide blood samples and consent to medical records being accessed.

It is hoped this research will demonstrate that prehabilitation builds physical strength and fitness, and this will to prevent problems after stem cell transplant, leading to faster recovery from treatment.
Eligibility

Key inclusion criteria

Participants recruited from haematology clinics at Eastern Health and affilitated haematology private practices where patients will be referred to Eastern Health for Auto SCT. Participants will be eligible if they: are aged 18 years and over; have a haematological malignancy and are waitlisted for autologous stem cell transplant; and are able to give written informed consent. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Participants will be excluded if patients have a medical condition that contraindicates participation in an exercise-based rehabilitation program as assessed by a physiotherapist or medical practitioner. 
•	They have an Australian-modified Karnofsky Performance status of <60 or ECOG >2. 
•	They have a cognitive impairment that precludes their ability to provide written, informed consent as assessed by their treating clinician.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Eastern Health
Primary Sponsor Address: Level 2, 5 Arnold St, Box Hill Victoria 3128
Primary Sponsor Country: Australia

Trial IDACTRN12620000496910

UTNU1111-1249-5528

Contact person for information and recruitmentDr
Amy Dennett
Eastern Health Allied Health Clinical Research Office, Level 2, 5 Arnold St Box Hill Victoria 3128
+61 390952442

Further information iconamy.dennett@easternhealth.org.au
Australia