Targeted Physiotherapeutic Treatment for Aromatase Inhibitor-associated Musculoskeletal Pain in Breast Cancer Survivors

NCT04560699 | Completed

• 1 other identifier: APPI2-PT-2020-AIMSS
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain

Keywords

aromatase inhibitors; breastcancer survivors

Outcome Measures

Primary Outcomes (1)

• Change in Brief pain inventory (BPI)

  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.

  Change from baseline to week 13

Secondary Outcomes (6)

• Change in Health related quality of life

  Change from baseline to week 13

• Adherence to aromatase-inhibitor (AI) drug

  week 13

• change in analgesics

  change from baseline to week 13

• Activities of daily living questionnaire (ADL-Q)

  baseline, week 6, week 13, week 26

• Change in physical activity

  change form baseline to week 13

Study Arms (2)

Physiotherapeutic group

ACTIVE COMPARATOR

medical care and physiotherapeutic treatment

Other: Physiotherapeutic treatment and medical care

medical care group

ACTIVE COMPARATOR

Medical care

Other: medical care

Interventions

Physiotherapeutic treatment and medical care OTHER

Physiotherapeutic treatment twice a week for twelve weeks and medical care three times at baseline, week 13 and week 26

Physiotherapeutic group

medical care OTHER

medical care three times during the study period; baseline, week 13 and week 26

medical care group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Frederiksberg University Hospital: lead

Study Sites (1)

Parker Instituttet, Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator is masked to group assignment for study analysis. Outcome assessor is masked to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: randomized 1:1 to intervention or control

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 23, 2020
• Study Start: October 14, 2020
• Primary Completion: January 4, 2024
• Study Completion: April 4, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

DK (1)