Self-Management for Joint Pain in Breast Cancer Survivors

(REJOIN Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining education and exercise can reduce joint pain in older breast cancer survivors starting Aromatase Inhibitors (AI), a common treatment known to cause pain. Participants will be divided into two groups: one will receive educational classes and group exercise, while the other will receive standard care plus additional information. The trial seeks women aged 60 and older who have completed initial cancer treatments and plan to start AI therapy, particularly those with joint pain and low physical activity levels. As an unphased trial, this study offers a unique opportunity to explore new methods to enhance quality of life during AI therapy.

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 prior data suggests that this self-management approach is safe for older breast cancer survivors?

Research has shown that exercise can safely and effectively help older breast cancer survivors manage joint pain caused by aromatase inhibitors (AIs). One study found that a self-guided walking program increased participants' weekly walking, indicating that physical activity can be a well-tolerated method to ease joint pain. Another study adapted an arthritis program specifically for breast cancer survivors, which also helped manage pain without serious side effects. These findings suggest that combining exercise with education might safely relieve joint pain for those undergoing AI therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the REJOIN approach because it combines education with exercise to tackle joint pain in breast cancer survivors, especially those on aromatase inhibitors (AIs). Unlike current treatments that often focus solely on medication or physical therapy, this method integrates group exercise sessions with discussions, promoting both physical and mental well-being. This holistic approach aims to improve adherence to AI therapy by directly addressing the joint pain side effect, offering a potentially more sustainable solution for long-term health.

What evidence suggests that this self-management approach is effective for joint pain in breast cancer survivors?

Research has shown that exercise can help reduce joint pain caused by aromatase inhibitors (AIs) in breast cancer survivors. The HOPE study found that physical activity eased joint pain in survivors who were previously inactive. Another study discovered that an 8-week home exercise program reduced joint pain for those on AI treatment. In this trial, participants in the "Treatment (Education plus Exercise)" arm will receive educational classes combined with exercise, similar to the REJOIN approach, which may help manage joint pain and encourage older breast cancer survivors to adhere to their AI medication. Participants in the "Enhanced Standard Care" arm will receive standard care plus a brochure about hormonal therapy use. ^{1 4 6 7 8}

Who Is on the Research Team?

Shirley M Bluethmann, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

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Study Design and Methods for the Using Exercise to Relieve ... The Using Exercise to Relieve Joint Pain and Improve AI Adherence in Older Breast Cancer Survivors (REJOIN) trial is a two-armed, pilot randomized controlled ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2014.57.1547

Randomized Exercise Trial of Aromatase Inhibitor–Induced ... The HOPE study demonstrates that exercise is effective in improving AI-induced arthralgia in previously inactive breast cancer survivors who adhere to their AI ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0923753419373181

Aromatase inhibitor-induced arthralgia: a review Up to half of women on AI therapy experience joint pain, and up to 20% will become non-compliant with the medicine because of the joint pain. Yet, very little ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34049837/

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

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ecc.12155

Exercise intervention in breast cancer patients with ... An 8-week, home-based exercise program may provide potential benefit to the breast cancer patients undergoing AI treatment by reducing joint ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879406821001193

Study design and methods for the using exercise to relieve ... Joint pain is a common AI-related symptom that is associated with low AI adherence. The Using Exercise to Relieve Joint Pain in Older Breast Cancer Survivors ( ...

7. cdc.gov cdc.gov/pcd/issues/2015/14_0535.htm

Adaptation of an Evidence-Based Arthritis Program ... We describe the adaptation of an evidence-based arthritis program for a new patient population — breast cancer survivors on AI therapy who are ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879406813003895

Feasibility and promise of a 6-week program to encourage ... A self-directed walking program among elderly breast cancer survivors on AI therapy significantly increased total time of walking per week over a 6 week period.