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

Feasibility of an Adapted Physical Activity Program for Patients Treated With an Autologous Hematopoietic Stem Cell Transplantation

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma; Myeloma; Autologous Transplant
• Intervention / Treatment: Other: Adapted Physical Activity

• Study Type: Interventional
• Enrollment (Anticipated): 57
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magali BALAVOINE; Phone Number: 0033 241682940; Email: m.balavoine@weprom.fr

Study Locations

• France
  • Angers, France
    • Not yet recruiting
    • CHU
    • Contact: Aline SCHMITD, MD
    • Principal Investigator: Aline SCHMITD, MD
  • Le Mans, France
    • Recruiting
    • Centre Jean Bernard/Clinique Victor Hugo
    • Principal Investigator: Katell LE DU, MD
    • Contact: LE DU Katell, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental arm; 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 gyma 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; 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 gyma 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the impact of an adapted physical activity program on the number of patients with sarcopenia following an autograft	Number of patients with sarcopenia within 6 months of autograft	6 months post-autograft
To assess quality of life	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	12 months post-autograft
To assess fatigue	Change in score of the multidimensional fatigue inventory questionnaire (20-100 with higher scores mean a worse outcome).	12 months post-autograft
To assess sexual function	Brief Index of Sexual Function for Women (5-75 with higher scores mean a better outcome).	12 months post-autograft
To assess sexual function	Male Sexual Health Questionnaire for men, Brief Index (5-125 with higher scores mean a better outcome).	12 months post-autograft
To assess patient's satisfaction	Specific questionnaire for study (6-25 with higher scores mean a better outcome).	6 months post-autograft
To assess progression free survival	Time between the inclusion date and the date of the first exam who show the progression of the disease	28 months
To assess the response rate	Number of patients with a partial or complete response according to Lugano criteria for lymphoma and IMWG (International Myeloma Working Group) for myeloma	28 months
To assess the global physical activity load by patient and by session	Calculated by Foster method	6 months post-autograft
To assess the prevalence of endocrinal disorder	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	28 months
To assess the prevalence of autograft's complication	Number of patients with autograft's complication at the numerator and the number of patients following at the denominator	28 months
To assess the duration and the cost of the hospitalization for the autograft	Hospitalizations will be quote (economic data) by medical information department of center	6 months
To assess the delay the period for resuming professional activity for the patients concerned, after the autograft	Delay between the date of autograft and the date of resuming professional activity	28 months

Collaborators and Investigators

• Sponsor: Weprom
• Investigators: Principal Investigator: Katell LE DU, MD, Centre Jean Bernard/Clinique Victor Hugo

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Sarcopenia; Autograft; Adapted Physical Activity
• Other Study ID Numbers: WP-2019-05; 2019-A02203-54 (Other Identifier: French Health Products Safety Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No