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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.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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
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.

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 groups in NCT05548686
Study groupRoleWhat they receive
Adapted Physical ActivityExperimentalPatients 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  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

  7. 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

  8. 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.

  1. First posted21 Sep 2022
  2. Study startNov 2022 (estimated)
  3. Primary completionApr 2023 (estimated)
  4. Study completionApr 2023 (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
15 participants (estimated)
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

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.

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