Physical Activity for Myeloma Autograft Longitudinal Study

NCT03946332 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-02-08

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Optional physical exercises

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

Sponsors & Collaborators

  • University Hospital, Rouen

    collaborator OTHER
  • University Hospital, Caen

    collaborator OTHER
  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Principal Investigators

  • caroline delette, MD · CHU Amiens

  • Pierre Morel, MD · CHU Amiens

  • Fabrice Jardin, Pr · CHU Rouen

  • Oana Brehar, MD · CHU Rouen

  • Vincent Camus, MD · CHU Rouen

  • Nathalie Cardinael, MD · CHU Rouen

  • Nathalie Contentin, MD · CHU Rouen

  • Marie-Laure Fontoura, MD · CHU Rouen

  • Carole Fronville Varnier, MD · CHU Rouen

  • Hélène Lanic, MD · CHU Rouen

  • Emilie Lemasle Hue, MD · CHU Rouen

  • Pascal Lenain, MD · CHU Rouen

  • Stéphane Lepretre, MD · CHU Rouen

  • Anna-Lise Menard, MD · CHU Rouen

  • Aspasia Stamatoullas-Bastard, MD · CHU Rouen

  • Hervé Tilly, MD · CHU Rouen

  • Gandhi L Damaj, Pr · CHU CAEN

  • Stéphane Cheze, MD · CHU CAEN

  • Margaret Macro, MD · CHU CAEN

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2023-05-01
Completion
2023-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03946332 on ClinicalTrials.gov