Physical activity & asymptomatic monoclonal gammopathies - Version 1
Research type
Research Study
Full title
Feasibility of a progressive, walking-based exercise programme for monoclonal gammopathy of undetermined significance and smouldering multiple myeloma: a randomised-controlled pilot trial.
IRAS ID
238573
Contact name
John P. Campbell
Contact email
Sponsor organisation
University of Bath
ISRCTN Number
ISRCTN65527208
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This pilot trial will determine the uptake, adherence, compliance, retention, and safety of an exercise programme in people diagnosed with the premalignant stages of the blood cancer multiple myeloma. The premalignant stages are called: (i) smouldering multiple myeloma and (ii) monoclonal gammopathy of undetermined significance (MGUS). MGUS is the earliest and least serious stage, however, some people with MGUS (called ‘intermediate-to-high risk’ MGUS) have an increased risk of getting myeloma compared to people with ‘low-risk’ MGUS. SMM is a more advanced and serious stage, and has a one in two chance of turning into myeloma within five years. No treatments are given to people with SMM and MGUS until incurable myeloma develops. Previous research has shown that physical activity can reduce the risk of getting myeloma. It is not known though if exercise does this by slowing down SMM and MGUS tumour growth. To date, studies have shown that exercise is acceptable and safe in multiple myeloma, but this has not yet been confirmed in SMM and MGUS. Accordingly, the main objective of this trial is to evaluate the feasibility and safety of an exercise programme in SMM and MGUS. Participants will be randomly assigned to the exercise group or control group for 16 weeks. The exercise group will receive a progressive, walking-based exercise programme, and the control group will receive normal care. The exercise programme is designed to improve fitness, strength and flexibility and it includes bouts of vigorous intensity exercise to elicit anti-inflammatory and anti-tumour effects. A key secondary outcome of this trial is change in SMM and MGUS disease activity, measured in blood samples. As part of a PhD project, this trial will also investigate potential exercise-induced mechanisms that might change tumour size, including: body composition, immune function, inflammation, and metabolic factors.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
18/LO/1034
Date of REC Opinion
20 Jul 2018
REC opinion
Further Information Favourable Opinion