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

NCT04320420 | Unknown

• 2 other identifiers: WP-2019-052019-A02203-54
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

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.

Conditions

Myeloma; Lymphoma; Autologous Transplant

Keywords

Adapted Physical Activity; Autograft; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• To assess the feasibility of an adapted physical activity program surrounding an autograft

  Proportion of patients performing all sessions offered per week and who performed exercises at home

  6 months post-autograft

Secondary Outcomes (13)

• To assess the impact of an adapted physical activity program on the number of patients with sarcopenia following an autograft

  6 months post-autograft

• To assess quality of life

  12 months post-autograft

• To assess fatigue

  12 months post-autograft

• To assess sexual function

  12 months post-autograft

• To assess sexual function

  12 months post-autograft

Study Arms (1)

Experimental arm

EXPERIMENTAL

The APA program is defined in 3 stages: STEP 1: during the initial chemotherapy over 3 months * 3 supervised APA sessions/week on site: * two muscle strengthening sessions, stretching, flexibility in the gym * a cardio session (Nordic Walking: outdoors) * at home: exercise book if the patient wishes STEP 2: during hospitalization for the autograft, over 1 month: * 2 sessions/week supervised by an APA engineer + exercise book and encouragement of individual work * If the patient wishes, he can continue the exercises carried out with the APA engineer independently STEP 3: after the transplant * the first 3 months: * 2 supervised indoor sessions/week (muscle strengthening, stretching, flexibility), * 1-hour cardio session/week independently * the following 3 months: 1 indoor session per week + independent exercises at home and walking or cycling sessions

Other: Adapted Physical Activity

Interventions

Adapted Physical Activity OTHER

The APA program is defined in 3 stages: STEP 1: during the initial chemotherapy over 3 months * 3 supervised APA sessions/week on site: * two muscle strengthening sessions, stretching, flexibility in the gym * a cardio session (Nordic Walking: outdoors) * at home: exercise book if the patient wishes STEP 2: during hospitalization for the autograft, over 1 month: * 2 sessions/week supervised by an APA engineer + exercise book and encouragement of individual work * If the patient wishes, he can continue the exercises carried out with the APA engineer independently STEP 3: after the transplant * the first 3 months: * 2 supervised indoor sessions/week (muscle strengthening, stretching, flexibility), * 1-hour cardio session/week independently * the following 3 months: 1 indoor session per week + independent exercises at home and walking or cycling sessions

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weprom: lead

Study Sites (2)

CHU

Angers, France

NOT YET RECRUITING

Centre Jean Bernard/Clinique Victor Hugo

Le Mans, France

RECRUITING

MeSH Terms

Conditions

Neoplasms, Plasma Cell; Lymphoma; Sarcopenia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Katell LE DU, MD

  Centre Jean Bernard/Clinique Victor Hugo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magali BALAVOINE

CONTACT

241682940; m.balavoine@weprom.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 25, 2020
• Study Start: November 20, 2020
• Primary Completion: April 1, 2023
• Study Completion: October 1, 2024
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)