Condition category
Cancer
Date applied
03/05/2018
Date assigned
14/05/2018
Last edited
11/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Smouldering multiple myeloma (SMM) and monoclonal gammopathy of undetermined significance (MGUS) are premalignant plasma cell conditions that precede the cancer multiple myeloma. Treatment is not administered to SMM or MGUS due to uncertainties about the effectiveness and toxicity (side effects) of existing treatment options. Lifestyle interventions to delay progression, such as exercise, have not been tested and may be beneficial. Population data shows that risk of getting multiple myeloma is reduced by about 20% in those who lead a physically active lifestyle. It is thought that exercise does not stop the initiation of MGUS/SMM, but instead may delay the progression of MGUS/SMM to multiple myeloma. One case study has shown that SMM disease activity can be reversed with exercise. The aim of this study is to assess the feasibility and safety of a progressive, walking-based exercise programme for SMM and MGUS, and to assess the impact of exercise on SMM and MGUS disease activity.

Who can participate?
Patients aged over 18 who have SMM or MGUS

What does the study involve?
Participants’ disease activity, physical fitness and quality of life are assessed. Participants are randomly allocated to receive a progressive exercise programme or usual care for 16 weeks. The exercise programme is run at the Royal United Hospitals Bath NHS Foundation Trust and consists of two supervised group classes per week and one session at home. The exercise programme includes cardio, strengthening and balance exercises, and stretching, as recommended by World Health Organisation physical activity guidelines for older adults. Disease activity, physical fitness and quality of life are measured again at 17 weeks. The usual care control group are offered the exercise programme at the end of their participation in the study.

What are the possible benefits and risks of participating?
There are both benefits and risks to taking part in the study. Benefits include a free exercise programme, feedback on health and fitness measures, a gift voucher and exercise resources to keep after the study. The researchers have designed the project to have the least risk possible, although not all risk is avoidable, for example, participating in a bout of exercise temporarily increases the risk of having heart problems or getting injured. Overall however, the potential benefits of exercise outweigh the possible negative consequences of exercise.

Where is the study run from?
Royal United Hospitals Bath NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
October 2017 to December 2019

Who is funding the study?
University of Bath (UK)

Who is the main contact?
1. Dr John Campbell
J.Campbell@bath.ac.uk
2. Miss Annabelle Emery
A.R.Emery@bath.ac.uk

Trial website

blogs.bath.ac.uk/exercise-and-haemotological-cancer/

Contact information

Type

Scientific

Primary contact

Miss Annabelle Emery

ORCID ID

http://orcid.org/0000-0001-9603-4931

Contact details

Office 4.113 1 West Building
Department for Health
University of Bath
Claverton Down
Bath
BA2 7AY
United Kingdom
+44 (0)1225 383655
a.r.emery@bath.ac.uk

Type

Scientific

Additional contact

Dr John Campbell

ORCID ID

http://orcid.org/0000-0001-9989-6158

Contact details

Office 5.123 1 West Building
Department for Health
University of Bath
Claverton Down
Bath
BA2 7AY
United Kingdom
+44 (0)1225 385495
j.campbell@bath.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Feasibility of a progressive, walking-based exercise programme for monoclonal gammopathy of undetermined significance and smouldering multiple myeloma: a randomised-controlled pilot trial

Acronym

Study hypothesis

The primary aim of this trial is to evaluate the feasibility and safety of a 16-week progressive, walking-based exercise programme in patients with (i) smouldering multiple myeloma (SMM) and (ii) monoclonal gammopathy of undetermined significance (MGUS).

The secondary aim of this trial is to generate preliminary data on the effects of an exercise programme on (i) disease activity, (ii) fitness, and (iii) quality of life outcomes to inform a future, adequately powered, randomised-controlled trial.

People with SMM and MGUS are at risk of progressing to the cancer multiple myeloma in their lifetime, but care guidelines do not recommend active treatment until multiple myeloma develops. This research is investigating whether a progressive exercise programme can be used to reduce disease activity.

Ethics approval

Approval pending - IRAS project ID: 238573

Study design

Pilot single-centre double-armed randomised-controlled phase I trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Premalignant plasma cell conditions: smouldering multiple myeloma and monoclonal gammopathy of undetermined significance

Intervention

Participants will be randomly allocated to either the treatment or control arm. Opaque envelopes containing group allocation will be sequenced using block randomisation into ‘Treatment Arm’ = 20 and ‘Control Arm’ = 20 (sealedenvelope.com).

Treatment arm: 16-week progressive, walking-based exercise programme. The programme will be delivered as two supervised group classes at the Royal United Hospitals Bath NHS Foundation Trust (including treadmill walking, resistance exercise and stretching) and home-based exercises (including one moderate intensity walk and daily balance and stretching exercises) each week, plus usual care.

Control arm: usual care and maintenance of baseline habitual exercise habits, with the option to undertake the exercise programme for 16 weeks after completing their trial period in the control group.

All participants will be measured at week 0 and 17.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Uptake, measured at week 0 prior to trial period:
1.1. Recruitment rate - the proportion of patients approached who are screened
1.2. Screen-pass rate - the proportion of patients who attend screening that are deemed eligible
1.3. Randomisation rate - the proportion of patients that are randomised
2. Adherence: the proportion of prescribed sessions that are performed, measured in weeks 1-16 in the treatment arm only
3. Compliance: the exercise prescribed vs. exercise completed, measured at weeks 1-16 in the treatment arm only
4. Retention: the proportion of participants who complete both baseline and follow-up measures, measured in week 17
5. Safety: the incidence and severity of adverse events, measured at weeks 0-17

Secondary outcome measures

1. Disease activity of SMM and MGUS, measured in week 0 and week 17
2. Physical fitness, measured by cardiopulmonary exercise test in week 0 and week 17
3. Physical activity level, measured by armband activity monitor in week 0 and week 16
4. Body composition, measured by dual-energy x-ray absorptiometry in week 0 and week 17
5. Quality of life, measured by questionnaires (quality of life, sleep, fatigue, frailty) in week 0 and week 17
6. Resting heart rate and blood pressure, measured in week 0 and week 17
7. CRAB indices (calcium, renal function, anaemia, bone health), measured in week 0 and week 17
8. Mechanistic measures (immune, inflammatory and metabolic biomarkers), measured in blood, saliva and urine sampled in week 0 and week 17

Overall trial start date

02/10/2017

Overall trial end date

13/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnostic criteria:
1.1. SMM. Defined by IMWG criteria as absence of MM defining events or amyloidosis, AND either: (i) serum monoclonal protein (IgG or IgA) >30g/L OR urinary monoclonal protein >500mg per 24h, AND/OR (ii) clonal bone marrow plasma cells 10-60%. People with SMM, given their higher risk of progressing to MM, will initially be prioritised for enrollment into the trial, followed by people with MGUS, described next
OR
1.2. MGUS. Defined by IMWG criteria as absence of end-organ damage attributable to the plasma cell proliferative disorder (such as hypercalcaemia, renal insufficiency, anaemia, and bone lesions [CRAB]), or amyloidosis AND BMPC <10% AND serum M-protein <30 g/L
2. Age >18 years (adults and seniors)

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. World Health Organisation (WHO) performance status >1
2. Pregnancy
3. Deemed unsafe to exercise according to the Physical Activity Readiness Questionnaire
4. Any comorbidity that is likely to progress or be exacerbated over the course of the trial period
5. Cognitive impairment deemed a risk by the healthcare team for participation in the trial
6. Unable to understand explanations and/or provide informed consent
7. Any condition and/or behaviour that would pose undue personal risk or introduce bias into the trial

Recruitment start date

02/07/2018

Recruitment end date

15/11/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal United Hospitals Bath NHS Foundation Trust
Combe Park
Bath
BA1 3NG
United Kingdom

Sponsor information

Organisation

University of Bath

Sponsor details

Vice-Chancellor's Office
University of Bath
Claverton Down
Bath
BA2 7AY
United Kingdom

Sponsor type

University/education

Website

bath.ac.uk

Funders

Funder type

University/education

Funder name

University of Bath

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The trial protocol has now been made available online via the University Research Portal (https://researchportal.bath.ac.uk/en/projects/feasibility-of-a-progressive-walking-based-exercise-programme-for). A protocol paper will also be published in an academic journal (aiming for BMJ Open), estimated timeline is 6-12 months following the start of data collection. The results of the trial will be disseminated in relevant clinical, academic and patient conferences and meetings. The results will also be written up as paper publications and submitted to scientific, peer-reviewed journals.

IPD sharing statement
De-identified individual participant data will be made available after publication to those who submit a research proposal that is approved by the Chief Investigator, Dr John Campbell (J.Campbell@bath.ac.uk). Data underlying the publication will be made available from the date of publication for 10 years, at which point it will be destroyed as stated in the University of Bath research data policy. The data will be held in the University of Bath Data Archive.

Intention to publish date

13/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes