Feasibility of an Adapted Physical Activity Program for Patients Treated With an Autograft (APA )

  • STATUS
    Recruiting
  • End date
    Oct 26, 2024
  • participants needed
    57
  • sponsor
    Weprom
Updated on 26 January 2021

Summary

Therapeutic intensification followed by an autograft of hematopoietic stem cells is a standard of care for young patients with myeloma from the first line and for lymphoma from the second or third line of treatment. This procedure remains toxic in the short and medium term with significant mortality and morbidity: the average mortality varies from 1.4 to 5%. The causes of death are linked to a severe infection, visceral bleeding or vital organ failure. This risk of mortality is partly correlated with sarcopenia.

Sarcopenia is defined by the reduction of muscle mass and strength. It was first described in the elderly and classified as geriatric syndrome such as dementia, falls or frailty. It varies from 5 to 13% between 60 and 70 years and between 11 and 50% beyond 80 years and is classified as primitive, that is to say related to age It can however be secondary to neoplasia. This event has been described in patients with hematologic malignancies during chemotherapy and can reach 55% of patients in the elderly. It is proportional to the intensity of the treatments. It emerges as an independent prognostic factor which is detrimental to survival in these patients. Physical exercise combined with nutritional support could reduce it.

The positive impact of adapted physical activity (APA) has been shown in numerous publications on reducing the incidence and risk of relapse for several cancers (breast, colon prostate). It is less obvious in hematology in view of studies published on APA with different physical activity programs depending on the time of the intervention or according to the type, duration and intensity.

The objective of this study is to assess the feasibility of an APA program in patients requiring an autologous hematopoietic stem cell transplant. It is expected that the program will have a protective effect on the appearance of induced sarcopenia and on the complications related to the procedure in the short and medium term regardless of the hematology center for patients receiving intensive treatment with support for autologous hematopoietic stem cells.

This is a feasibility study.

Details
Condition Multiple Myeloma, Lymphoma, autologous transplantation, Lymphoproliferative Disorder, Lymphoma, Non-Hodgkin's Lymphoma, Lymphoproliferative disorders, autologous transplant, autograft, lymphomas, multiple myeloma (mm), autologous graft
Treatment adapted physical activity
Clinical Study IdentifierNCT04320420
SponsorWeprom
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years
Patient with lymphoma or myeloma justifying an autograft of hematopoietic stem cells whatever the line of treatment
Patient affiliated to a social security scheme
Patient who has given written consent before any specific procedure related to the study

Exclusion Criteria

Central and / or peripheral neurological deficit not allowing adapted physical activity sessions to be carried out
Uncontrolled hypertension
Left ventricular Ejection Fraction <50%
Chronic respiratory insufficiency with alterations in the functional respiratory investigations
Active viral infection: hepatitis B, C and HIV
Pregnancy or breastfeeding
Persons deprived of their liberty or under guardianship
Dementia, mental alteration or psychiatric pathology which could compromise the patient's informed consent and / or compliance with the protocol and follow-up of the trial
Patient who can't follow protocol for psychological, social, family or geographic reasons
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