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.
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,
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- 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.
France2 sites, 2 recruiting
- Not yet recruiting
CHU
Angers
Aline SCHMITD, MD
Aline SCHMITD, MD
- Recruiting
Centre Jean Bernard/Clinique Victor Hugo
Le Mans
LE DU Katell, MD
Katell LE DU, MD
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.
- Conditions
- Myeloma, Lymphoma, Autologous Transplant
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Adapted Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
To assess patient's satisfaction
Specific questionnaire for study (6-25 with higher scores mean a better outcome).
Measured: 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
Measured: 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
Measured: 28 months
To assess the global physical activity load by patient and by session
Calculated by Foster method
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start20 Nov 2020
- Primary completionApr 2023 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katell LE DU, MD, Principal investigator, Centre Jean Bernard/Clinique Victor Hugo
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Adapted Physical Activity Program for Patients Treated With an Autologous Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04320420
- Acronym / sponsor ID
- APA² / WP-2019-05
- Conditions
- Myeloma, Lymphoma, Autologous Transplant
- Keywords
- Adapted Physical Activity, Autograft, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- WepromUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Other: Adapted Physical ActivityThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Physical ActivityThe 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 | Experimental arm |
Primary outcome
To assess the feasibility of an adapted physical activity program surrounding an autograft
Time frame: 6 months post-autograft
Proportion of patients performing all sessions offered per week and who performed exercises at home
13 secondary outcomes
To assess the impact of an adapted physical activity program on the number of patients with sarcopenia following an autograft
Time frame: 6 months post-autograft
To assess quality of life
Time frame: 12 months post-autograft
To assess fatigue
Time frame: 12 months post-autograft
To assess sexual function
Time frame: 12 months post-autograft
To assess sexual function
Time frame: 12 months post-autograft
To assess patient's satisfaction
Time frame: 6 months post-autograft
To assess progression free survival
Time frame: 28 months
To assess the response rate
Time frame: 28 months
To assess the global physical activity load by patient and by session
Time frame: 6 months post-autograft
To assess the prevalence of endocrinal disorder
Time frame: 28 months
To assess the prevalence of autograft's complication
Time frame: 28 months
To assess the duration and the cost of the hospitalization for the autograft
Time frame: 6 months
To assess the delay the period for resuming professional activity for the patients concerned, after the autograft
Time frame: 28 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katell LE DU, MD principal investigator
Centre Jean Bernard/Clinique Victor Hugo
2 sites in 1 country: see every site and its status.
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?
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.