Multiple myeloma lifestyle study

ISRCTN	ISRCTN38480455
DOI	https://doi.org/10.1186/ISRCTN38480455
Protocol serial number	16255
Sponsor	University College London
Funders	Cancer Research UK, Celgene Europe Ltd

Submission date: 29/07/2015
Registration date: 29/07/2015
Last edited: 22/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-lifestyle-after-treatment-for-myeloma

Contact information

Dr Maggie Heinrich
Public

University College London
Gower Street
London
WC1E 6BT
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised; Interventional and Observational; Design type: Treatment, Cohort study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Lifestyle study of patients with multiple myeloma
Study objectives	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.
Ethics approval(s)	NRES Committee London - Queen Square, 10/01/2014, ref: 13/LO/1105
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Fatigue; Timepoint(s): baseline, 3, 6 and 12 months
Key secondary outcome measure(s)	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
Completion date	31/12/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	138
Total final enrolment	131
Key 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
Key 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
Date of first enrolment	19/06/2014
Date of final enrolment	30/04/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University College London Hospital,

Haematology
Cancer Division
250 Euston Road
London
NW1 2PJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2020	22/05/2020	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

22/05/2020: Publication reference and total final enrolment number added.
26/06/2018: The overall trial end date was changed from 30/04/2016 to 31/12/2017.
01/06/2018: No publications found, verifying study status with principal investigator.

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.