Physical Activity for Myeloma Autograft Longitudinal Study

Physical Exercises for Patient Undergoing Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Controlled Randomised Prospective Multicentre Longitudinal Study.

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Collaborator: University Hospital, Rouen
University Hospital, Caen

Source Centre Hospitalier Universitaire, Amiens
Brief Summary

Physical exercises program is known to improve quality of life, chronical fatigue and appears to be a behavioural recommendation against cancer as primary and tertiary prevention. Nutritional status is also important in cancer patients: a loss of 5% of weight increases the complication risks and decreases survival and the quality of life. Interactions between physical activity and haematological malignancies are less described compared to solid cancers. Methodology and protocols are also heterogeneous. Supervised exercises program improves the physical condition and the quality of life; however there are few randomised studies versus a controlled group. Post autograft evaluation for myeloma patients showed a physical deficit with increased fat mass, but in this particular population physical exercises need to be more explored. This project is a randomised study versus controlled group that evaluates supervised physical exercises program in a homogenous population: patients under-65-years-old with multiple myeloma and who will undergo autologous stem cell transplantation.

Detailed Description

Physical exercises program is known to improve quality of life, chronical fatigue and appears to be a behavioural recommendation against cancer as primary and tertiary prevention. Nutritional status is also important in cancer patients: a loss of 5% of weight increases the complication risks and decreases survival and the quality of life. Interactions between physical activity and haematological malignancies are less described compared to solid cancers. This multicentre project is a randomised study versus controlled group that evaluates supervised physical exercises program in a homogenous population: patients under-65-years-old with multiple myeloma and who will undergo autologous stem cell transplantation. The hypothesis of this study is that a supervised physical exercises program during and after autograft might have a positive impact on the physical capacities and the quality of life.

In the experimental arm, patients will benefit regularly from a physical exercises program during their hospitalization. When going back home, they will be given a practical help kit with specific equipment (dumbbell, elastic), an actimeter with heart rate monitoring (in order to have an objective collection of the physical practice in addition to a self-evaluation) and a physical exercises program on paper and video supports, that patients would have learnt during their hospitalization. Furthermore, SMS will be regularly sent to remind them to practice. In the controlled arm, patients will be hospitalized in the same conditions than the experimental group and can practice if they want. At the end of the hospitalization, they will receive a paper document with global informations about physical exercises including a few simple exercises. Evaluations will be carried out in both arms at day 0, day 30 and day 90 from autograft. The post graft follow up will be done at the same time as the medical consultation and before the maintenance treatment.

Overall Status Not yet recruiting
Start Date May 2019
Completion Date August 2021
Primary Completion Date May 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Measure of quality of life with EORTC QLQ-C30 questionnaire at day 0 from autograft as patient will be hospitalized.
Measure of quality of life with EORTC QLQ-C30 questionnaire at day 30 from autograft as patient will be hospitalized.
Measure of quality of life with EORTC QLQ-C30 questionnaire at day 90 from autograft as patient will be hospitalized.
Measure of quality of life with QLQ-MY20 questionnaire at day 0 from autograft as patient will be hospitalized.
Measure of quality of life measured with QLQ-MY20 questionnaire at day 30 from autograft as patient will be hospitalized.
Measure of quality of life measured with QLQ-MY20 questionnaire at day 90 from autograft as patient will be hospitalized.
Secondary Outcome
Measure Time Frame
Measure of fatigue evaluated by Piper scale at day 0 from autograft as patient will be hospitalized.
Measure of fatigue evaluated by Piper scale at day 30 from autograft as patient will be hospitalized.
Measure of fatigue evaluated by Piper scale at day 90 from autograft as patient will be hospitalized.
Enrollment 100
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Physical exercises

Description: patients will benefit regularly from a physical exercises program during their hospitalization. When going back home, they will be given a practical help kit with specific equipment (dumbbell, elastic), an actimeter with heart rate monitoring (in order to have an objective collection of the physical practice in addition to a self-evaluation) and a physical exercises program on paper and video supports, that patients would have learnt during their hospitalization.

Arm Group Label: Physical exercise arm

Intervention Type: Behavioral

Intervention Name: Optional physical exercises

Description: patients will be proposed for the physical exercises and will practice them if they want.

Arm Group Label: controlled arm

Eligibility

Criteria:

Inclusion Criteria:

- Under 65-year-old patient

- more than 18 years old

- Hospitalized for autologous stem cell transplantation

- First or second line therapy for multiple myeloma

- Chemotherapy regimen with melphalan

- Patient affiliated to the social security system

- Signed informed consent form

- Patient who have computer and internet connection at home

Exclusion Criteria:

- Over-65-year-old patient

- Other haematological malignancies

- More than 2 treatment lines

- Other regimen of chemotherapy for autograft than melphalan

- Contraindication to physical exercises: uncontrolled arterial hypertension or diabetes, heart or respiratory failure, psycho-cognitive disorders that may compromise the physical exercises program

- dialyzed patient

- Adult patient under tutelage

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Marie Beaumont, MD

Phone: (33)322455914

Email: [email protected]

Verification Date

May 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Physical exercise arm

Type: Experimental

Description: patients will benefit regularly from a physical exercises program during their hospitalization. When going back home, they will be given a practical help kit with specific equipment (dumbbell, elastic), an actimeter with heart rate monitoring (in order to have an objective collection of the physical practice in addition to a self-evaluation) and a physical exercises program on paper and video supports, that patients would have learnt during their hospitalization. Furthermore, SMS will be regularly sent to remind them to practice

Label: controlled arm

Type: Active Comparator

Description: patients will be hospitalized in the same conditions than the experimental group and will be able to practice if they want.

Acronym PAMAL
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov