Clinical trial NCT03946332: Physical Activity for Myeloma Autograft Longitudinal Study
Official title: Physical Exercises for Patient Undergoing Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Controlled Randomised Prospective Multicentre Longitudinal Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Multiple Myeloma
Quality of Life
Keywords: physical activity
multiple myeloma
autologous stem cell transplantation
quality of life
physical conditioning
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: University Hospital, Rouen
name: University Hospital, Caen
First posted: 2019-05-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Measure of quality of life with EORTC QLQ-C30 questionnaire
timeFrame: at day 0 from autograft as patient will be hospitalized.
measure: Measure of quality of life with EORTC QLQ-C30 questionnaire
timeFrame: at day 30 from autograft as patient will be hospitalized.
measure: Measure of quality of life with EORTC QLQ-C30 questionnaire
timeFrame: at day 90 from autograft as patient will be hospitalized.
measure: Measure of quality of life with QLQ-MY20 questionnaire
timeFrame: at day 0 from autograft as patient will be hospitalized.
measure: Measure of quality of life measured with QLQ-MY20 questionnaire
timeFrame: at day 30 from autograft as patient will be hospitalized.
measure: Measure of quality of life measured with QLQ-MY20 questionnaire
timeFrame: at day 90 from autograft as patient will be hospitalized.
Secondary outcomes:
measure: Measure of fatigue evaluated by Piper scale
timeFrame: at day 0 from autograft as patient will be hospitalized.
measure: Measure of fatigue evaluated by Piper scale
timeFrame: at day 30 from autograft as patient will be hospitalized.
measure: Measure of fatigue evaluated by Piper scale
timeFrame: at day 90 from autograft as patient will be hospitalized.
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: caroline delette, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Pierre Morel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Fabrice Jardin, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Oana Brehar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Vincent Camus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Nathalie Cardinael, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Nathalie Contentin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Marie-Laure Fontoura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Carole Fronville Varnier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Hélène Lanic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Emilie Lemasle Hue, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Pascal Lenain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Stéphane Lepretre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Anna-Lise Menard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Aspasia Stamatoullas-Bastard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Hervé Tilly, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU CAEN
name: Gandhi L Damaj, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU CAEN
name: Stéphane Cheze, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU CAEN
name: Margaret Macro, MD
role: PRINCIPAL_INVESTIGATOR
References: