Self-Management for Joint Pain in Breast Cancer Survivors

(REJOIN Trial)

Recruiting at 2 trial locations

Overseen By Rebecca Dellinger, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Must be taking: Aromatase inhibitors

Disqualifiers: Metastatic cancer, Recent stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on those planning to start Aromatase Inhibitors (AIs), so you may need to discuss your current medications with the trial team.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on those planning to start Aromatase Inhibitors (AIs), so you may need to discuss your current medications with the trial team.

What data supports the effectiveness of the treatment for joint pain in breast cancer survivors?

Research suggests that exercise and education can help manage joint pain in breast cancer survivors taking aromatase inhibitors (AIs), potentially improving their adherence to the medication. A study found that a 6-week walking program reduced joint symptoms in elderly breast cancer survivors on AI therapy, indicating that physical activity may be an effective way to alleviate joint pain. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment for joint pain in breast cancer survivors?

Research suggests that exercise and education can help manage joint pain in breast cancer survivors taking aromatase inhibitors (AIs), potentially improving their adherence to the medication. A study found that a 6-week walking program reduced joint symptoms in elderly breast cancer survivors on AI therapy, indicating that physical activity may be an effective way to manage AI-related joint pain. ^{1 2 3 4 5}

Is the self-management treatment for joint pain in breast cancer survivors safe?

The self-management treatment, which includes exercise and education, is generally safe for breast cancer survivors. While aromatase inhibitors (AIs) used in treatment can cause joint pain and other side effects, these are usually manageable with standard painkillers, exercise, and other interventions. ^{1 3 6 7 8}

Is the self-management treatment for joint pain in breast cancer survivors safe?

The self-management treatment, which includes exercise and education, is generally safe for breast cancer survivors. While aromatase inhibitors (AIs) used in treatment can cause joint pain and other side effects, these are usually manageable with standard painkillers, exercise, and other interventions. ^{1 3 6 7 8}

How is the REJOIN treatment for joint pain in breast cancer survivors different from other treatments?

The REJOIN treatment is unique because it combines exercise and education to help manage joint pain and improve adherence to aromatase inhibitors (AIs) in older breast cancer survivors, whereas other treatments often rely on painkillers or alternative therapies like acupuncture. ^{1 2 3 5 9}

How is the REJOIN treatment for joint pain in breast cancer survivors different from other treatments?

The REJOIN treatment is unique because it combines exercise and education to help breast cancer survivors manage joint pain and improve adherence to aromatase inhibitors, unlike standard treatments that often rely on painkillers or other medications. ^{1 2 3 5 10}

What is the purpose of this trial?

The purpose of this pilot intervention study is to test the effectiveness of a self-management approach (combining education- and exercise-based strategies) for improving arthralgia (joint pain) associated with Aromatase Inhibitors (AI) in older breast cancer survivors. Survivors will be recruited from local cancer clinics prior to the completion of primary cancer treatment, as arthralgia can occur soon after initiating AI medication. Participants will be randomized to one of two groups: an enhanced standard care group (AI prescription plus information) or a treatment group (educational classes plus group exercise sessions). Older survivors (≥60 years) will be targeted because they are at increased risk of medication complications which may impede adherence. For the baseline assessment, a cancer-specific geriatric assessment will be conducted and a blood sample will be collected to interpret the effects of the self-management study in the context of geriatric experiences. Additionally, there will be an assessment of knowledge, PA habits, and AI-related joint pain and AI adherence. These will be measured again at 4, 6 and at follow up at 12 months.

Research Team

Shirley M Bluethmann, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for female breast cancer survivors aged 60 or older who are about to start Aromatase Inhibitors (AI) treatment. They must be able to exercise, have internet access for Zoom sessions, and not be very physically active currently. Those with severe cognitive issues, recent heart problems, joint surgeries, or already on AI therapy for more than 24 weeks can't join.

Inclusion Criteria

I can attend bi-weekly Zoom classes for 8 weeks.

I am a woman aged 60 or older.

Minimum cognitive impairment (verified by cognitive screening questions administered by phone or in-person interview)

Exclusion Criteria

I started taking Aromatase Inhibitors less than 6 months ago.

I recently had joint surgery or have a condition that limits my physical activity.

I have not had a stroke, heart attack, severe heart failure, or irregular heartbeat in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

A cancer-specific geriatric assessment and blood sample collection to interpret the effects of the self-management study

1 visit

1 visit (in-person)

Treatment

Participants receive either enhanced standard care or education plus exercise intervention, including bi-weekly supervised exercise and educational sessions

8 weeks

Bi-weekly remote sessions

At-home Program

Participants continue exercise at home with provided resistance bands and follow-up phone calls to assess progress

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 4, 6, and 12 months

12 months

Assessments at 4, 6, and 12 months

Treatment Details

Interventions

• Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN)

Trial Overview The REJOIN Trial tests a self-management program combining education and group exercises aimed at reducing joint pain from AI medication in older breast cancer survivors. Participants will either receive standard care plus information or enter the treatment group with educational classes and exercise sessions.

Participant Groups

Group I: Treatment (Education plus Exercise) Experimental Treatment 1 Intervention

Participants will receive the same materials as the standard care group, plus participate in group exercise and group discussion sessions.

Group II: Enhanced Standard Care Active Control 1 Intervention

Participants will receive standard care, plus a brochure about hormonal therapy use.

Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN) is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Aromatase Inhibitors for:

• Breast cancer
• Infertility
• Precocious puberty
• Medical abortion
• Gynecomastia

Approved in United States as Aromatase Inhibitors for:

• Breast cancer
• Gynecomastia

Approved in Canada as Aromatase Inhibitors for:

• Breast cancer
• Gynecomastia

Approved in Japan as Aromatase Inhibitors for:

• Breast cancer
• Gynecomastia

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Findings from Research

The REJOIN Trial aims to evaluate a 16-week self-management intervention combining exercise and education to help older breast cancer survivors manage joint pain and improve adherence to aromatase inhibitors (AIs).

This pilot study targets sedentary women aged 65 and older who have completed primary cancer treatment, potentially providing a non-pharmacological approach to enhance health outcomes and support survivorship in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study design and methods for the using exercise to relieve joint pain and improve AI adherence in older breast cancer survivors (REJOIN) trial. Bluethmann, SM., Truica, C., Klepin, HD., et al.[2022]

A 6-week self-directed walking program significantly increased the proportion of elderly female breast cancer survivors on aromatase inhibitors who walked the recommended 150 minutes per week, rising from 21% to 50%.

While joint pain, stiffness, and fatigue showed decreases during the program, these changes were not statistically significant, indicating the need for further research with a larger sample size to confirm the effectiveness of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and promise of a 6-week program to encourage physical activity and reduce joint symptoms among elderly breast cancer survivors on aromatase inhibitor therapy. Nyrop, KA., Muss, HB., Hackney, B., et al.[2016]

Aromatase inhibitors (AIs) improve outcomes for patients with endocrine-sensitive breast cancer compared to tamoxifen alone, but they frequently cause arthralgia, which is more common in real-world settings than in clinical trials.

Management of AI-related arthralgia includes standard painkillers, NSAIDs, and alternative therapies, which can enhance treatment adherence and improve the quality of life for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Aromatase inhibitors and arthralgia]. Nagykálnai, T., Landherr, L., Mészáros, E.[2018]

Postmenopausal women starting aromatase inhibitors (AIs) experienced significantly more severe joint pain (arthralgia) compared to a control group, with pain worsening over the first year of treatment.

Baseline factors such as the severity of menopausal symptoms and existing joint issues were linked to increased arthralgia severity, suggesting that these factors can help identify patients at higher risk for developing joint pain during AI therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time course of arthralgia among women initiating aromatase inhibitor therapy and a postmenopausal comparison group in a prospective cohort. Castel, LD., Hartmann, KE., Mayer, IA., et al.[2021]

Breast cancer survivors on aromatase inhibitors (AIs) often experience joint pain, and many expressed a desire for more information about these potential side effects at the time of prescription, indicating a need for better communication from healthcare providers.

Participants showed a willingness to manage their joint pain through moderate physical activity, such as walking, especially if recommended by their oncologist, highlighting an opportunity for healthcare providers to promote physical activity as a beneficial strategy during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aromatase inhibitor associated arthralgia: the importance of oncology provider-patient communication about side effects and potential management through physical activity. Nyrop, KA., Callahan, LF., Rini, C., et al.[2022]

Aromatase inhibitors (AIs) are becoming the preferred first-line treatment for postmenopausal patients with hormone-sensitive early breast cancer, significantly reducing the risk of cancer recurrence.

While AIs can lead to side effects such as decreased bone density, increased joint pain (arthralgia), and vaginal health issues, these effects are generally manageable, and addressing them is crucial for improving the quality of life and adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of adjuvant endocrine therapies in hormone receptor-positive early breast cancer. Sehdev, S., Martin, G., Sideris, L., et al.[2021]

In a survey of 200 postmenopausal women undergoing aromatase inhibitor therapy for breast cancer, 47% reported joint pain and 44% reported joint stiffness related to the treatment, indicating these symptoms are more common than previously noted in clinical trials.

Patients who received taxane chemotherapy were found to be over four times more likely to experience AI-related joint symptoms, while being overweight and prior tamoxifen therapy were associated with a lower risk of these symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of joint symptoms in postmenopausal women taking aromatase inhibitors for early-stage breast cancer. Crew, KD., Greenlee, H., Capodice, J., et al.[2022]

A study of 123 breast cancer survivors taking aromatase inhibitors (AIs) found that beliefs about endocrine therapy significantly influenced their intention to continue AI treatment, highlighting the importance of patient education and support.

Despite 87% of participants experiencing musculoskeletal pain, this pain did not directly affect their intention to continue AIs; however, it was linked to increased fear of cancer recurrence, suggesting that managing pain could improve overall treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What influences aromatase inhibitor continuation intention among breast cancer survivors? Seo, YK., Park, J., Park, JH., et al.[2022]

A pilot study involving 32 postmenopausal women with early breast cancer showed that acupuncture is feasible and safe for treating joint pain caused by aromatase inhibitors, with no serious adverse events reported.

While the study did not find significant differences in pain and stiffness outcomes, there were positive trends favoring real electroacupuncture in improving stiffness and physical function at 12 weeks, suggesting potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for treatment of arthralgia secondary to aromatase inhibitor therapy in women with early breast cancer: pilot study. Oh, B., Kimble, B., Costa, DS., et al.[2013]

Aromatase inhibitors (AIs) are more effective than tamoxifen in reducing breast cancer recurrences, but they are associated with a higher incidence of musculoskeletal symptoms, particularly joint pain and stiffness, which can affect patient compliance.

Current research on treating or preventing AI-related joint pain is still in early stages, with no clear effective treatment identified yet, largely due to limitations like small sample sizes and inconsistent definitions of the syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptoms: Aromatase Inhibitor Induced Arthralgias. Hershman, DL., Loprinzi, C., Schneider, BP.[2016]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Study design and methods for the using exercise to relieve joint pain and improve AI adherence in older breast cancer survivors (REJOIN) trial. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility and promise of a 6-week program to encourage physical activity and reduce joint symptoms among elderly breast cancer survivors on aromatase inhibitor therapy. [2016]

3. Hungary pubmed.ncbi.nlm.nih.gov

[Aromatase inhibitors and arthralgia]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Time course of arthralgia among women initiating aromatase inhibitor therapy and a postmenopausal comparison group in a prospective cohort. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Aromatase inhibitor associated arthralgia: the importance of oncology provider-patient communication about side effects and potential management through physical activity. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of adjuvant endocrine therapies in hormone receptor-positive early breast cancer. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Prevalence of joint symptoms in postmenopausal women taking aromatase inhibitors for early-stage breast cancer. [2022]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

What influences aromatase inhibitor continuation intention among breast cancer survivors? [2022]

9. England pubmed.ncbi.nlm.nih.gov

Acupuncture for treatment of arthralgia secondary to aromatase inhibitor therapy in women with early breast cancer: pilot study. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Symptoms: Aromatase Inhibitor Induced Arthralgias. [2016]