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MyelomaAPA²NCT04320420

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

A study testing Adapted Physical Activity in people with Myeloma and Lymphoma, run by Weprom at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloma, Lymphoma, Autologous Transplant
What is being tested?
Adapted Physical Activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
2 sitesFrance
Study dates
20 Nov 2020to Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 9Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Magali BALAVOINE contact

241682940 ext. 0033

m.balavoine@weprom.fr

France2 sites, 2 recruiting

  • CHU

    Angers

    Aline SCHMITD, MD

    Aline SCHMITD, MD

    Not yet recruiting

  • Centre Jean Bernard/Clinique Victor Hugo

    Le Mans

    LE DU Katell, MD

    Katell LE DU, MD

    Recruiting

Other trials in France

About this study

Official title: 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.

Read more

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.

Being tested
Adapted Physical Activity
Keywords
Adapted Physical Activity, Autograft, Sarcopenia
Medical subject headings
Neoplasms, Plasma Cell, Lymphoma, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adapted Physical ActivityOther

    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
Study groups in NCT04320420
Study groupRoleWhat they receive
Experimental armExperimentalThe 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
Receives: Other: Adapted Physical Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months post-autograft

Secondary outcomes (13)

  1. 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

    Measured: 6 months post-autograft

  2. 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

    Measured: 12 months post-autograft

  3. To assess fatigue

    Change in score of the multidimensional fatigue inventory questionnaire (20-100 with higher scores mean a worse outcome).

    Measured: 12 months post-autograft

  4. To assess sexual function

    Brief Index of Sexual Function for Women (5-75 with higher scores mean a better outcome).

    Measured: 12 months post-autograft

  5. To assess sexual function

    Male Sexual Health Questionnaire for men, Brief Index (5-125 with higher scores mean a better outcome).

    Measured: 12 months post-autograft

  6. To assess patient's satisfaction

    Specific questionnaire for study (6-25 with higher scores mean a better outcome).

    Measured: 6 months post-autograft

  7. To assess progression free survival

    Time between the inclusion date and the date of the first exam who show the progression of the disease

    Measured: 28 months

  8. 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

    Measured: 28 months

  9. To assess the global physical activity load by patient and by session

    Calculated by Foster method

    Measured: 6 months post-autograft

  10. 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

    Measured: 28 months

  11. 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

    Measured: 28 months

  12. 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

    Measured: 6 months

  13. 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

    Measured: 28 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2020
  2. Study start20 Nov 2020
  3. Primary completionApr 2023 (estimated)
  4. Study completionOct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04320420
Sponsor's protocol ID
WP-2019-05
Other IDs
2019-A02203-54
Acronym
APA²
Status last verified
Oct 2021
First submitted
20 Mar 2020
Last updated
8 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Adapted Physical Activity in people with Myeloma and Lymphoma, run by Weprom at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Magali BALAVOINE (241682940 ext. 0033, m.balavoine@weprom.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the feasibility of an adapted physical activity program surrounding an autograft (time frame: 6 months post-autograft). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04320420.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.

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