Physical Activity for Myeloma Autograft Longitudinal Study

NCT ID: NCT03946332

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2023-12-31

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.

Conditions

Physical Activity; Multiple Myeloma; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Physical exercise 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

Group Type: EXPERIMENTAL

Physical exercises

Intervention Type: BEHAVIORAL

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.

controlled arm

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

Group Type: ACTIVE_COMPARATOR

Optional physical exercises

Intervention Type: BEHAVIORAL

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

Interventions

Physical exercises

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.

Intervention Type: BEHAVIORAL

Optional physical exercises

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: collaborator

University Hospital, Caen

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

caroline delette, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Pierre Morel, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Fabrice Jardin, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Oana Brehar, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Vincent Camus, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Nathalie Cardinael, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Nathalie Contentin, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Marie-Laure Fontoura, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Carole Fronville Varnier, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Hélène Lanic, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Emilie Lemasle Hue, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Pascal Lenain, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Stéphane Lepretre, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Anna-Lise Menard, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Aspasia Stamatoullas-Bastard, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Hervé Tilly, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Gandhi L Damaj, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU CAEN

Stéphane Cheze, MD

Role: PRINCIPAL_INVESTIGATOR

CHU CAEN

Margaret Macro, MD

Role: PRINCIPAL_INVESTIGATOR

CHU CAEN

Locations

CHU Amiens

Amiens, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marie Beaumont, MD

Role: CONTACT

beaumont.marie@chu-amiens.fr

(33)322455914

Quentin Vacandare, Pr

Role: CONTACT

vacandare.quentin@chu-amiens.fr

(33)322456443

Other Identifiers

PI2018_843_0008

Identifier Type: -

Identifier Source: org_study_id