Clinical trial NCT04320420: Feasibility of an Adapted Physical Activity Program for Patients Treated With an Autograft (APA²)
Official title: Feasibility of an Adapted Physical Activity Program for Patients Treated With an Autologous Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myeloma
Lymphoma
Autologous Transplant
Keywords: Adapted Physical Activity
Autograft
Sarcopenia
Lead sponsor: Weprom
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Central and / or peripheral neurological deficit not allowing adapted physical activity sessions to be carried out,
2. Uncontrolled hypertension,
3. Left ventricular Ejection Fraction \<50%,
4. Chronic respiratory insufficiency with alterations in the functional respiratory investigations,
5. Active viral infection: hepatitis B, C and HIV,
6. Pregnancy or breastfeeding,
7. Persons deprived of their liberty or under guardianship
8. 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,
9. Patient who can't follow protocol for psychological, social, family or geographic reasons.

Primary outcomes:
measure: To assess the feasibility of an adapted physical activity program surrounding an autograft
timeFrame: 6 months post-autograft
Secondary outcomes:
measure: To assess the impact of an adapted physical activity program on the number of patients with sarcopenia following an autograft
timeFrame: 6 months post-autograft
measure: To assess quality of life
timeFrame: 12 months post-autograft
measure: To assess fatigue
timeFrame: 12 months post-autograft
measure: To assess sexual function
timeFrame: 12 months post-autograft
measure: To assess sexual function
timeFrame: 12 months post-autograft
measure: To assess patient's satisfaction
timeFrame: 6 months post-autograft
measure: To assess progression free survival
timeFrame: 28 months
measure: To assess the response rate
timeFrame: 28 months
measure: To assess the global physical activity load by patient and by session
timeFrame: 6 months post-autograft
measure: To assess the prevalence of endocrinal disorder
timeFrame: 28 months
measure: To assess the prevalence of autograft's complication
timeFrame: 28 months
measure: To assess the duration and the cost of the hospitalization for the autograft
timeFrame: 6 months
measure: To assess the delay the period for resuming professional activity for the patients concerned, after the autograft
timeFrame: 28 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU
city: Le Mans
country: France
facility: Centre Jean Bernard/Clinique Victor Hugo
Study officials:
affiliation: Centre Jean Bernard/Clinique Victor Hugo
name: Katell LE DU, MD
role: PRINCIPAL_INVESTIGATOR
References: