Contributions
Abstract: PB2168
Type: Publication Only
Background
Exercise is considered to be feasible, safe and beneficial for patients with haematological cancer. However, patients with Multiple Myeloma (MM) are not only underrepresented in exercise studies (3 RCT, 1 pilot), the studies also primarily include younger patients with MM prior to, undergoing and after autologous stem cell transplantation. Due to the bone disease in MM, exercise can be challenging. Our ongoing RCT examines the effect of an individualized, early initiated exercise intervention (EI) in newly diagnosed patients with MM, irrespective of age.
Aims
The aim of the present study is to report the interim analysis of feasibility and safety of the EI.
Methods
This is a two-center RCT with blinded outcome assessors. Informed consent is obtained. Exclusion criteria include radiology assessed risk of fractures according to scoring system. Baseline tests are carried out within 4 days after starting anti-myeloma treatment, followed by randomization to control group (CG) or intervention group (IG). Randomization is stratified according to planned treatment (high dose chemotherapy with autologous stem cell transplantation or non-intensive treatment), WHO performance status (0-1 or ≥2) and study site.
The EI starts within one week and is a 10-week supervised and home-based exercise program comprising aerobic and strengthening exercises and physical activity in accordance with international guidelines. Both groups (CG and IG) receive written information about physical activity and transfer techniques (usual care). Main objectives are muscle strength (knee extensor strength and grip strength), physical function (6 minutes walk test and 30 seconds sit to stand test) and physical activity (monitored by use of ActivPal 3 micro). Feasibility outcome measures were eligibility, acceptance and drop-out rates. Further, adherence, tolerability and safety (adverse events (AEs)) of the supervised exercise sessions (SES) were obtained.
Results
Of 49 patients screened, 40 (82%) were eligible for inclusion; 30 (75%) accepted participation and were randomized (IG n=17, CG n=13). The participants´ (n=30) age in years (median (range)) was 69 (38-90). Of the 17 IG participants, 14 (82%) started intervention. Withdrawals prior to start of EI (n=3) was caused by no surplus energy (n=1), wish for treatment closer to home (n=1), and sudden impairment (n=1). Two withdrew during the EI period due to stroke (n=1) and because exercise was found too hard (n=1). One CG participant dropped out after receiving usual care because of no surplus energy. In the total period from baseline to end of the intervention 12 participants (71%) completed the intervention, and in the total period five IG participants dropped out (29%).
Of those starting EI (n=14) the adherence to SES was 94%, and the tolerability was 98%; two patients discontinued one SES each due to non-serious AEs (symptoms of pain, and dyspnea and dizziness).
No serious AEs were reported, and importantly, no patients had pathological fractures during the EI.
Conclusion
Early initiated exercise in newly diagnosed patients with MM, regardless of age and intensity of anti-myeloma treatment, is feasible, safe and tolerable. Early initiated exercise may be important in preventing physical decline during treatment for MM.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): Multiple Myeloma, Randomized, Safety, Supportive care
Abstract: PB2168
Type: Publication Only
Background
Exercise is considered to be feasible, safe and beneficial for patients with haematological cancer. However, patients with Multiple Myeloma (MM) are not only underrepresented in exercise studies (3 RCT, 1 pilot), the studies also primarily include younger patients with MM prior to, undergoing and after autologous stem cell transplantation. Due to the bone disease in MM, exercise can be challenging. Our ongoing RCT examines the effect of an individualized, early initiated exercise intervention (EI) in newly diagnosed patients with MM, irrespective of age.
Aims
The aim of the present study is to report the interim analysis of feasibility and safety of the EI.
Methods
This is a two-center RCT with blinded outcome assessors. Informed consent is obtained. Exclusion criteria include radiology assessed risk of fractures according to scoring system. Baseline tests are carried out within 4 days after starting anti-myeloma treatment, followed by randomization to control group (CG) or intervention group (IG). Randomization is stratified according to planned treatment (high dose chemotherapy with autologous stem cell transplantation or non-intensive treatment), WHO performance status (0-1 or ≥2) and study site.
The EI starts within one week and is a 10-week supervised and home-based exercise program comprising aerobic and strengthening exercises and physical activity in accordance with international guidelines. Both groups (CG and IG) receive written information about physical activity and transfer techniques (usual care). Main objectives are muscle strength (knee extensor strength and grip strength), physical function (6 minutes walk test and 30 seconds sit to stand test) and physical activity (monitored by use of ActivPal 3 micro). Feasibility outcome measures were eligibility, acceptance and drop-out rates. Further, adherence, tolerability and safety (adverse events (AEs)) of the supervised exercise sessions (SES) were obtained.
Results
Of 49 patients screened, 40 (82%) were eligible for inclusion; 30 (75%) accepted participation and were randomized (IG n=17, CG n=13). The participants´ (n=30) age in years (median (range)) was 69 (38-90). Of the 17 IG participants, 14 (82%) started intervention. Withdrawals prior to start of EI (n=3) was caused by no surplus energy (n=1), wish for treatment closer to home (n=1), and sudden impairment (n=1). Two withdrew during the EI period due to stroke (n=1) and because exercise was found too hard (n=1). One CG participant dropped out after receiving usual care because of no surplus energy. In the total period from baseline to end of the intervention 12 participants (71%) completed the intervention, and in the total period five IG participants dropped out (29%).
Of those starting EI (n=14) the adherence to SES was 94%, and the tolerability was 98%; two patients discontinued one SES each due to non-serious AEs (symptoms of pain, and dyspnea and dizziness).
No serious AEs were reported, and importantly, no patients had pathological fractures during the EI.
Conclusion
Early initiated exercise in newly diagnosed patients with MM, regardless of age and intensity of anti-myeloma treatment, is feasible, safe and tolerable. Early initiated exercise may be important in preventing physical decline during treatment for MM.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): Multiple Myeloma, Randomized, Safety, Supportive care