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Physical Activity for Myeloma Autograft Longitudinal Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03946332
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Centre Hospitalier Universitaire, Amiens
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 caroline delette, MDPierre Morel, MDFabrice Jardin, PrOana Brehar, MDVincent Camus, MDNathalie Cardinael, MDNathalie Contentin, MDMarie-Laure Fontoura, MDCarole Fronville Varnier, MDHélène Lanic, MDEmilie Lemasle Hue, MDPascal Lenain, MDStéphane Lepretre, MDAnna-Lise Menard, MDAspasia Stamatoullas-Bastard, MDHervé Tilly, MDGandhi L Damaj, PrStéphane Cheze, MDMargaret Macro, MD
Principal Investigator Affiliation CHU AmiensCHU AmiensCHU RouenCHU RouenCHU RouenCHU RouenCHU RouenCHU RouenCHU RouenCHU RouenCHU RouenCHU RouenCHU RouenCHU RouenCHU RouenCHU RouenCHU CaenCHU CaenCHU Caen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Physical Activity, Multiple Myeloma, Quality of Life
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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

Active Comparator: controlled arm

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Amiens, Amiens, France

Status

Recruiting

Address

CHU Amiens

Amiens, , 80054

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