Feasibility of an Adapted Physical Activity Program for Patients Treated With an Autograft (APA²)

Not Applicable

Recruiting

• Conditions: Myeloma; Autologous Transplant; Lymphoma

• Registration Number: NCT04320420
• Lead Sponsor: Weprom

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-25
• Study Start: 2020-11-20
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-08
• Primary Completion: 2023-04
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the feasibility of an adapted physical activity program surrounding an autograft	6 months post-autograft	Proportion of patients performing all sessions offered per week and who performed exercises at home

Secondary Outcome Measures

Name	Time	Method
To assess sexual function	12 months post-autograft	Male Sexual Health Questionnaire for men, Brief Index (5-125 with higher scores mean a better outcome).
To assess the impact of an adapted physical activity program on the number of patients with sarcopenia following an autograft	6 months post-autograft	Number of patients with sarcopenia within 6 months of autograft
To assess quality of life	12 months post-autograft	Change in score of the Quality of Life Questionnaire (General, 30 questions) of European Organisation for the Research and Treatment of Cancer. All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems
To assess fatigue	12 months post-autograft	Change in score of the multidimensional fatigue inventory questionnaire (20-100 with higher scores mean a worse outcome).
To assess the prevalence of endocrinal disorder	28 months	Number of patients with endocrinal disorder between the date of inclusion and the date of end of study at the numerator and the number of patients following at the denominator
To assess the prevalence of autograft's complication	28 months	Number of patients with autograft's complication at the numerator and the number of patients following at the denominator
To assess the response rate	28 months	Number of patients with a partial or complete response according to Lugano criteria for lymphoma and IMWG (International Myeloma Working Group) for myeloma
To assess progression free survival	28 months	Time between the inclusion date and the date of the first exam who show the progression of the disease
To assess the delay the period for resuming professional activity for the patients concerned, after the autograft	28 months	Delay between the date of autograft and the date of resuming professional activity
To assess patient's satisfaction	6 months post-autograft	Specific questionnaire for study (6-25 with higher scores mean a better outcome).
To assess the global physical activity load by patient and by session	6 months post-autograft	Calculated by Foster method
To assess the duration and the cost of the hospitalization for the autograft	6 months	Hospitalizations will be quote (economic data) by medical information department of center

Trial Locations

Locations (2)

CHU; 🇫🇷 Angers, France

Centre Jean Bernard/Clinique Victor Hugo; 🇫🇷 Le Mans, France