Condition category
Cancer
Date applied
29/07/2015
Date assigned
29/07/2015
Last edited
18/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Public

Primary contact

Dr Maggie Heinrich

ORCID ID

Contact details

University College London
Gower Street
London
WC1E 6BT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16255

Study information

Scientific title

Lifestyle study of patients with multiple myeloma

Acronym

Study hypothesis

The aim of this study is to evaluate the practicality and feasibility of carrying out an exercise training programme in patients with myeloma (a cancer of the bone marrow), and to determine the benefits of such a programme. The programme will improve fatigue by clinically significant levels after 3 months of the exercise programme, when compared with usual care.

The registration was initiated on 20/03/2014 and finalised on 29/07/2015. Following the prospective submission on 20/03 /2014, there were no changes to the protocol prior to registration being finalised. The recruitment started on 19/06/2014, after initiation of public registration.

Ethics approval

NRES Committee London - Queen Square, 10/01/2014, ref: 13/LO/1105

Study design

Randomised; Interventional and Observational; Design type: Treatment, Cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Cancer; Subtopic: Haematological Oncology; Disease: Myeloma

Intervention

Patients are randomised to either a control group or to receive a physical activity intervention.

Patients in the control group receive usual care which includes their regular check-ups in the UCLH myeloma clinic and/or their local hospitals and receiving maintenance or consolidation treatment, if applicable.

Patients in the treatment arm are offered a physical activity programme, led by a physiotherapist, which requires them to attend a hospital gym once a week as well as carry out a home-based programme of exercises two days a week. After the 3 months patients attend the gym once a month and follow a home-based exercise programme three days a week for 3 additional months.

Patients in both control and intervention groups are assessed in terms of outcome measures at 3, 6 and 12 months follow up.

Follow Up Length: 12 month(s)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Fatigue; Timepoint(s): baseline, 3, 6 and 12 months

Secondary outcome measures

1. Anxiety and depression; Timepoint(s): baseline, 3, 6 and 12 months
2. Body mass and body composition; Timepoint(s): baseline, 3, 6 and 12 months
3. Diet; Timepoint(s): baseline, 3, 6 and 12 months
4. Exercise capacity and cardiorespiratory fitness; Timepoint(s): baseline, 3, 6 and 12 months
5. Haematology, biochemistry, bone health markers (basic ALP, osteocalcin); Timepoint(s): baseline, 3, 6 and 12 months
6. Muscle strength and endurance; Timepoint(s): baseline, 3, 6, 12 months
7. Physical activity; Timepoint(s): baseline, 3, 6 and 12 months
8. Resting blood pressure; Timepoint(s): baseline, 3, 6 and 12 months
9. Self-efficacy; Timepoint(s): baseline, 3, 6 and 12 months
10. Sleep quality; Timepoint(s): baseline, 3, 6 and 12 months
11. Well-being; Timepoint(s): baseline, 3, 6 and 12 months

Overall trial start date

05/06/2014

Overall trial end date

30/04/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Myeloma survivors, who are assigned to UCLH myeloma clinics
2. Stable disease for at least 6 weeks, off treatment or on maintenance or consolidation treatment
3. Ability to give informed consent
4. A good performance status (ECOG 02)
5. Clinically able to carry out an exercise training programme on a regular basis (assessed by initial screening)
6. Aged at least 18

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 138; UK Sample Size: 138; Description: Patients with Multiple Myeloma; 34 in control group and 104 in the intervention group (3:1 randomisation)

Participant exclusion criteria

1. Spinal instability (as assessed on radiology in multidisciplinary team (MDT)) meetings
2. Those who have recently (within 4 weeks) had spinal or other surgery for pathological fractures
3. An abnormal resting ECG, where clinically indicated unexplained by further cardiological workup
4. At risk of pathological fracture (Mirel’s score, see Appendix 1 of Protocol)
5. Already participating in an exercise programme as part of a research study
6. Unstable angina
7. Musculoskeletal disease limiting mobility
8. Cognitive impairment that impedes ability to complete questionnaires

Recruitment start date

19/06/2014

Recruitment end date

30/04/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London Hospital,
Haematology, Cancer Division, 250 Euston Road,
London
NW1 2PJ
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

UCL Cancer Institute
Paul O'Gorman Building
72 Huntley Street
London
WC1E 6DD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Celgene Europe Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of the trial will be disseminated in relevant scientific conferences and meetings. The results will also be written up as paper publications and submitted to scientific, peer-reviewed journals. This is planned for the end of 2016.

Intention to publish date

31/12/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes