Multiple MyelomaALGOMYELOMOVNCT05548686
Benefits of Adapted Physical Activity for Chronic Osteoarticular Pain in Patients With Multiple Myeloma
A study testing adapted physical activity in people with Multiple Myeloma and Adapted Physical Activity, run by University Hospital, Caen.
Trial summary
Pain is one of the most frequent symptoms leading patients to consult a doctor, particularly in rheumatology and cancerology. When it becomes chronic, pain is the cause of a major emotional and physical invasion, with harmful repercussions on the family, social and professional levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Adapted Physical Activity, Chronic Pain
- What is being tested?
- adapted physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Apr 2023
- 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
- Patients with chronic pain related to multiple myeloma, which has been evolving for more than 3 months and whose intensity is assessed with a VAS > 30/100
- Patients who have completed more than 3 months of induction chemotherapy for Multiple Myeloma.
- Patients not eligible for bone marrow transplantation.
- Patient able to read, understand French and self-assess their pain on the VAS
- Patient followed in the haematology department of the Caen University Hospital and living in Calvados
Who cannot join
- Patients with absolute contraindications to Adapted Physical Activity.
- Unstable angina
- Decompensated heart failure
- Complex ventricular rhythm disorders
- Severe uncontrolled hypertension
- PAH > 60mmHg
Show all 20Show fewer
- Presence of large or pedunculated intra-cavity thrombus
- Acute pericardial effusion
- Severe obstructive cardiomyopathy
- Tight and/or symptomatic aortic stenosis
- Recent thrombophlebitis with or without pulmonary embolism
- Diabetes with plantar perforating disease for activities involving the lower limbs
- Patient eligible for a bone marrow transplant.
- Patients with a major and/or potentially dangerous osteolytic lesion.
- Patients who do not meet the criteria for "moderate" functional impairment (assessed at the inclusion visit). defined by the HAS in 2019
- Pregnant or lactating woman.
- Minor patient.
- Patient under legal protection.
- Patient who does not read or understand French.
- Patient undergoing physiotherapy at the time of inclusion.
About this study
Pain is one of the most frequent symptoms leading patients to consult a doctor, particularly in rheumatology and cancerology. When it becomes chronic, pain is the cause of a major emotional and physical invasion, with harmful repercussions on the family, social and professional levels. It is therefore necessary to be able to propose different therapies.
For many years, non-medicinal techniques have been proving their benefits and their central role in the treatment of chronic pain. Physical activity has been widely demonstrated in the literature to have considerable physical benefits (reduced risk of hypertension, vascular accidents, diabetes, improved bone condition, weight control, etc.) but also psychological benefits. However, according to the WHO, nearly 31% of adults aged 15 and over were not physically active in 2008. Physical inactivity is considered the 4th leading risk factor for death in the world. It is estimated to be the main cause of 21 to 25% of breast and colon cancers.
Read more
The investigators therefore propose a feasibility study, interventional, with minimal risks and constraints, evaluating the effectiveness of adapted physical activity in chronic pain related to a pathology little studied in this field of management: multiple myeloma. This study will include about 15 patients with residual pain 3 months after the end of their induction chemotherapy treatment.
Adapted Physical Activity sessions will be performed for 12 weeks. The evaluation of the expected benefits on pain and its consequences (cognitive, emotional, behavioral, physical ...) will be done through simple and validated questionnaires as well as on the evolution of the consumption of analgesics. The expected duration of the study will be one year.
- Conditions
- Multiple Myeloma, Adapted Physical Activity, Chronic Pain
- Being tested
- adapted physical activity
- Medical subject headings
- Multiple Myeloma, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapted physical activityOther
3 sessions of adapted physical activity per week during 12 weeks for each patient
| Study group | Role | What they receive |
|---|---|---|
| Adapted Physical Activity | Experimental | Patients benefiting from adapted physical activity Receives: Other: adapted physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of adapted physical activity on the intensity of chronic pain related to multiple myeloma
Evaluation of the pain intensity with the visual analogue scale from 0 to 100 (with the help of the ruler) over time
Measured: difference between Month 0, Month 3, Month 6
Secondary outcomes (8)
Evaluate the impact of adapted physical activity on pain
Brief Pain Inventory (BPI), 7 items from 0 (no discomfort) to 10 (complete discomfort) on the impact of the pain (sleep, enjoyment of life, relationships with others, work, general activity, ability to walk, mood. Score for each item.
Measured: difference between Month 0, Month 3, Month 6
To evaluate the impact of APA on the consumption of analgesics.
Percentage of patients who reduced their treatment at the end of follow-up
Measured: difference between Month 0, Month 3, Month 6
Evaluate the impact of adapted physical activity on catastrophizing
Pain Catastrophization Scale (PCS) Questionnaires reporting the patient's thoughts when in pain (e.g., "I'm afraid to die") ranging from "not at all = 0" to "all the time = 4". Total score out of 52.
Measured: difference between Month 0, Month 3, Month 6
Evaluate the impact of adapted physical activity on anxiety and depression
Assessment of anxiety and depression with the Hospital Anxiety and Depression Scale (HAD score) 14 items from 0 to 3: a total score from 0 to 42 and 2 other scores differentiating anxiety and depression
Measured: difference between Month 0, Month 3, Month 6
Evaluate the impact of adapted physical activity on sleep
Sleep assessment wit the PSQI (Pittsburgh Sleep Quality Index) 19 self-report questions and 5 questions asked of the spouse or roommate (if any). Only the self-report questions are included in the score. The 19 self-report questions combine to give 7 "components" of the overall score, with each component receiving a score from 0 to 3. In all cases, a score of 0 indicates no difficulty while a score of 3 indicates severe difficulty. The 7 components of the score are added together to give an overall score ranging from 0 to 21 points, with 0 indicating no difficulty and 21 indicating major difficulty.
Measured: difference between Month 0, Month 3, Month 6
Evaluate the impact of adapted physical activity on physical activity
Physical activity assessment with the International Physical Activity Questionnaire (IPAQ) 7 questions about daily physical activity in the last 7 days, distinguishing between time spent doing moderate-intensity physical activity (carrying light loads, vacuuming, cycling quietly, playing volleyball ...), high-intensity physical activity (carrying heavy loads, digging, mountain biking, playing soccer ...), and time spent walking and sitting. Depending on the intensity (converted into METs), duration and number of days in the week, a physical activity score is defined ranging from low, moderate to high.
Measured: difference between Month 0, Month 3, Month 6
Evaluate the impact of adapted physical activity on self-esteem
Assessment of Self-esteem with Physical Self Inventory (ISP25) 25 items composed of 6 scales: at the general level, a global self-esteem scale with 5 items, of which 2 items are presented in positive form (items 1 and 2) and 3 items in negative form (items 7, 13 and 19); at the physical level, a perceived physical value scale with 5 positive items (2, 8, 14, 20 and 24) ; 4 other subscales correspond to the physical condition, evaluated on the basis of the endurance race with 5 items, of which 3 positive items (items 9, 15 and 21) and 2 negative items (items 3 and 25), the sports competence made up of 4 items in positive form (items 4, 10, 16, 22), the physical appearance made up of 3 items of which 1 positive item (item 11) and two negative items (items 5 and 17) and the strength with 3 positive items (items 6, 12 and 18). The scoring of the negative items is reversed.
Measured: difference between Month 0, Month 3, Month 6
Evaluate the impact of adapted physical activity on quality of life
Assessment of quality of life with the Quality of Life Questionnaires in Cancer (QLQC30).
28 questions with 4 items ranging from "not at all" to "a lot" and dealing with the evaluation of several parameters (current and during the past week): physical, social, cognitive, personal and psychological functioning, overall health status, fatigue, nausea vomiting, pain, dyspnea, insomnia, loss of appetite, constipation, diarrhea, fincial problems. There are also 2 additional questions ranging from 1 "very poor" to 7 "excellent" on the overall quality of life felt by the patient. Measurement of the total quality of life score combining all 30 questions.
Measured: difference between Month 0, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study startNov 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548686
- Sponsor's protocol ID
- 20-163
- Other IDs
- 2020-A02599-30
- Acronym
- ALGOMYELOMOV
- Status last verified
- Dec 2021
- First submitted
- 7 Dec 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Adapted Physical Activity for Chronic Osteoarticular Pain in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05548686
- Acronym / sponsor ID
- ALGOMYELOMOV / 20-163
- Conditions
- Multiple Myeloma, Adapted Physical Activity, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 21 Sep 2022 (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.
Pain is one of the most frequent symptoms leading patients to consult a doctor, particularly in rheumatology and cancerology. When it becomes chronic, pain is the cause of a major emotional and physical invasion, with harmful repercussions on the family, social and professional levels. It is therefore necessary to be able to propose different therapies.
For many years, non-medicinal techniques have been proving their benefits and their central role in the treatment of chronic pain. Physical activity has been widely demonstrated in the literature to have considerable physical benefits (reduced risk of hypertension, vascular accidents, diabetes, improved bone condition, weight control, etc.) but also psychological benefits. However, according to the WHO, nearly 31% of adults aged 15 and over were not physically active in 2008. Physical inactivity is considered the 4th leading risk factor for death in the world. It is estimated to be the main cause of 21 to 25% of breast and colon cancers.
The investigators therefore propose a feasibility study, interventional, with minimal risks and constraints, evaluating the effectiveness of adapted physical activity in chronic pain related to a pathology little studied in this field of management: multiple myeloma. This study will include about 15 patients with residual pain 3 months after the end of their induction chemotherapy treatment.
Adapted Physical Activity sessions will be performed for 12 weeks. The evaluation of the expected benefits on pain and its consequences (cognitive, emotional, behavioral, physical ...) will be done through simple and validated questionnaires as well as on the evolution of the consumption of analgesics. The expected duration of the study will be one year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adapted Physical Activity | Experimental | Other: adapted physical activityPatients benefiting from adapted physical activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with chronic pain related to multiple myeloma, which has been evolving for more than 3 months and whose intensity is assessed with a VAS > 30/100
Key exclusion criteria (20 listed)
- Patients with absolute contraindications to Adapted Physical Activity.
- Patient eligible for a bone marrow transplant.
- Patients with a major and/or potentially dangerous osteolytic lesion.
- Patients who do not meet the criteria for "moderate" functional impairment (assessed at the inclusion visit). defined by the HAS in 2019
- Pregnant or lactating woman.
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 activity3 sessions of adapted physical activity per week during 12 weeks for each patient | Other | Adapted Physical Activity |
Primary outcome
To evaluate the impact of adapted physical activity on the intensity of chronic pain related to multiple myeloma
Time frame: difference between Month 0, Month 3, Month 6
Evaluation of the pain intensity with the visual analogue scale from 0 to 100 (with the help of the ruler) over time
8 secondary outcomes
Evaluate the impact of adapted physical activity on pain
Time frame: difference between Month 0, Month 3, Month 6
To evaluate the impact of APA on the consumption of analgesics.
Time frame: difference between Month 0, Month 3, Month 6
Evaluate the impact of adapted physical activity on catastrophizing
Time frame: difference between Month 0, Month 3, Month 6
Evaluate the impact of adapted physical activity on anxiety and depression
Time frame: difference between Month 0, Month 3, Month 6
Evaluate the impact of adapted physical activity on sleep
Time frame: difference between Month 0, Month 3, Month 6
Evaluate the impact of adapted physical activity on physical activity
Time frame: difference between Month 0, Month 3, Month 6
Evaluate the impact of adapted physical activity on self-esteem
Time frame: difference between Month 0, Month 3, Month 6
Evaluate the impact of adapted physical activity on quality of life
Time frame: difference between Month 0, Month 3, Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing adapted physical activity in people with Multiple Myeloma and Adapted Physical Activity, run by University Hospital, Caen.
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 5 inclusion and 20 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 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the impact of adapted physical activity on the intensity of chronic pain related to multiple myeloma (time frame: difference between Month 0, Month 3, Month 6). 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 21 Sep 2022.