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Trial record 1 of 1 for:    NCT04560699
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Targeted Physiotherapeutic Treatment for Aromatase Inhibitor-associated Musculoskeletal Pain in Breast Cancer Survivors (AIMSS)

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ClinicalTrials.gov Identifier: NCT04560699
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : October 10, 2022
Sponsor:
Information provided by (Responsible Party):
Cecilie Bartholdy, Frederiksberg University Hospital

Brief Summary:

The primary objective of this trial is to assess the efficacy of targeted individualised physiotherapeutic treatment on aromatase inhibitor-associated musculoskeletal pain.

This trial asks a critical, previously unaddressed, question of clinical importance about management of musculoskeletal (MSK) pain secondary to aromatase inhibitor (AI) treatment of hormone receptor-positive breast cancer. Many breast cancer survivors taking AIs experience muscle and/or joint pain, which may cause many to stop taking AIs and may inhibit exercise or physical activity, despite its known health benefits.

Physiotherapeutic treatment is considered a standard management strategy for many MSK pain conditions, in which targeted specific exercise therapy is now as an evidence-based management strategy with proven effectiveness and patient satisfaction. Thus, referral to physiotherapy would be a natural strategy in women who experience MSK pain as an adverse effect to AI therapy. However, it is unclear if physiotherapeutic treatment has similar effects on AI induced MSK pain as in primary MSK pain. Two systematic review (one with a meta-analysis) have assessed the effect of different pain management strategies for AI-induced MSK-pain and found great uncertainty in the effects of exercise, relaxation techniques and acupuncture. They also found limited evidence on the subject and moderate to low quality of the studies included. The evidence on the subject is clearly limited but the need for a treatment option to minimize the side-effects of the AI medication real and necessary.

Targeted individualised physiotherapeutic treatment is tailored for the affected (painful) tissue/joint/region specifically and is based on extensive experience and evidence from MSK physiotherapy in rheumatic and orthopedic patient population. Targeted individualised physiotherapy treatment take into account the individual patient, her constitution, the painful tissue/region/joint (e.g. its biomechanics, physiological properties, and inflammatory activity), and is adjusted according to day-to-day variations in pain and progressed based on the interaction between changes in symptoms and function and tissue healing. Such approach is expected to yield a greater effect on MSK pain, than a generic exercise program. Further, targeted treatment programs are delivered by trained physiotherapists, who have specific clinical training and experience in clinical management of patient and handling MSK pain, which is also expected to yield better clinical outcomes than programs delivered by people without clinical training.

Altogether it is very likely that a targeted physiotherapy treatment will be of significant benefit to breast cancer survivors with AI induced MSK pain.

The aim is to compare targeted individualized physiotherapeutic treatment and medical care with medical care alone on aromatase inhibitor associated musculoskeletal pain in female breast cancer survivors.

It is hypothesized that targeted physiotherapeutic treatment and medical care reduces musculoskeletal pain significantly in women with aromatase inhibitor associated musculoskeletal pain when compared to medical care alone.

The plan is to include 120 participants from the oncology department at Rigshospitalet, Denmark.

Participants will partake in the study for a total of 26 weeks. During the first 12 week the intervention group will receive the physiotherapeutic treatment twice a week. The medical care visits are place at the first visit to the clinic, week 13 and week 26.


Condition or disease Intervention/treatment Phase
Musculoskeletal Pain Other: Physiotherapeutic treatment and medical care Other: medical care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized 1:1 to intervention or control
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The investigator is masked to group assignment for study analysis. Outcome assessor is masked to group allocation
Primary Purpose: Treatment
Official Title: Targeted Physiotherapeutic Treatment for Aromatase Inhibitor-associated Musculoskeletal Pain in Breast Cancer Survivors: a Randomized Controlled Trial
Actual Study Start Date : October 14, 2020
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Physiotherapeutic group
medical care and physiotherapeutic treatment
Other: Physiotherapeutic treatment and medical care
Physiotherapeutic treatment twice a week for twelve weeks and medical care three times at baseline, week 13 and week 26

Active Comparator: medical care group
Medical care
Other: medical care
medical care three times during the study period; baseline, week 13 and week 26




Primary Outcome Measures :
  1. Change in Brief pain inventory (BPI) [ Time Frame: Change from baseline to week 13 ]
    The BPI is a 14-item questionnaire developed for use in cancer patients, and assesses pain over the past week, reported on a 0-10 scale, where mild pain as a score of 3-4, moderate pain score of 5-7, and severe pain score of 8-10. The BPI consists of two subscales: pain severity and pain interference.


Secondary Outcome Measures :
  1. Change in Health related quality of life [ Time Frame: Change from baseline to week 13 ]
    The European quality of life, five dimensions, 3 point Likert scale (EQ-5D-3L) questionnaire ( measures on a 3 point Likert scale; no problems, some problems, and extreme problems.

  2. Adherence to aromatase-inhibitor (AI) drug [ Time Frame: week 13 ]
    participants are asked if the adhere to their AI-treatment

  3. change in analgesics [ Time Frame: change from baseline to week 13 ]
    participants are asked if the take analgesics for their MSK pain

  4. Activities of daily living questionnaire (ADL-Q) [ Time Frame: baseline, week 6, week 13, week 26 ]
    The ADL-Q was developed to measure perceived quality of different ADL activities. The ADL-Q consists of 12 domains and a total of 47 items: 31 Personal ADL (PADL) and 16 Instrumental ADL (IADL) items. The PADL items are rated within the last 24 hours and the IADL items are rated within the last week. Each item is rated with seven response categories reflecting independence, safety, efficiency, and effort/fatigue

  5. Change in physical activity [ Time Frame: change form baseline to week 13 ]
    The questionnaire physical activity scale (PAS) is used to assess average activity level. The PAS consist of one question: how physically active are you during a regular day? Divide the 24 hours into relevant categories of activity: sleeping, sitting down watching tv/playing computer, low activity (for example doing laundry), moderate activity (for example cleaning), high intensity activity (for example running fast).

  6. Change in Grip strength [ Time Frame: change from baseline to week 13 ]
    Grip strength will be measured using an electronic dynamometer (North Coast Medical Inc.). The maximal strength (in kilo gram) will be measured three times and the maximal value will be reported. Both the dominant and non-dominant hand will be measured.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adequately treated primary invasive breast cancer with surgery (breast conserving surgery or mastectomy) and radiotherapy if applicable
  • Estrogen receptor positive tumor with staining of ≥10% tumorcells
  • Aromatase inhibitor treatment
  • Perceived musculoskeletal pain in the upper or lower extremities attributable to AI treatment for at least 2 month and a maximum of 24 months
  • Age ≥18
  • Willing and able to understand and participate in the study

Exclusion Criteria:

  • Locally advanced breast cancer or distant metastases
  • Lymphedema
  • Inflammatory rheumatic diseases (rheumatoid arthritis, Psoriatic arthritis, etc.)
  • Widespread or generalized pain syndrome (e.g. fibromyalgia)
  • Lumbar or cervical nerve root compression
  • Poly-arthrosis resulting in joint replacement surgery
  • Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560699


Locations
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Denmark
Parker Instituttet, Frederiksberg Hospital Recruiting
Frederiksberg, Denmark, 2000
Contact: Cecilie Bartholdy, phd    +45 38164161    cecilie.roedgaard.bartholdy@regionh.dk   
Contact: Marius Henriksen, phd    +45 38164160    marius.henriksen@regionh.dk   
Sponsors and Collaborators
Frederiksberg University Hospital
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Responsible Party: Cecilie Bartholdy, Principal investigator, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT04560699    
Other Study ID Numbers: APPI2-PT-2020-AIMSS
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: October 10, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: At the end of the study inclusion, it will be decided if any individual participant data will be made available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cecilie Bartholdy, Frederiksberg University Hospital:
aromatase inhibitors
breastcancer survivors
Additional relevant MeSH terms:
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Musculoskeletal Pain
Mastodynia
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations