Online Program for Aromatase Inhibitor Pain Trial for Early-Stage Breast Cancer

Overview: This study is officially called Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia. The goal is to see if an online training course can help women taking an aromatase inhibitor after surgery to remove early-stage breast cancer to better manage any joint, bone, and muscle pain they’re having as a result of the aromatase inhibitor.

Phase: Phase III; Phase III trials compare the safety and effectiveness of a new treatment to the current standard of care. Phase III trials are usually large – some involve thousands of people – and are done at many places in the United States and around the world. 

Number of people to enroll: 452

ClinicalTrials.gov ID number: NCT05703178

Sponsor of the trial: Northwestern University

The trial is for post-menopausal women diagnosed with stage I, stage II, or stage III hormone receptor-positive breast cancer who are taking an aromatase inhibitor after breast cancer surgery and have bone or joint pain related to the aromatase inhibitor.

Bone and joint pain is a common and problematic side effect of the aromatase inhibitors used to treat breast cancer: Arimidex (chemical name: anastrozole), Aromasin (chemical name: exemestane), and Femara (chemical name: letrozole).

Many women stop taking an aromatase inhibitor because of bone and joint pain.

The researchers developed an online training program to help women taking an aromatase inhibitor more confidently manage any pain associated with taking the medicine. The researchers’ goals are to improve the women’s quality of life and help them complete the full course of aromatase inhibitor treatment.

The study includes four parts, all of which participants will complete at home. Women in the study will:

1. Sponsor Message

   Fill out four sets of questionnaires during the nine- to 10-month study.

2. Sponsor Message

   Attend three video conference meetings during the first month of the study.

3. Sponsor Message

   Use an electronic pill bottle to track when they take the aromatase inhibitor.

For the fourth part of the study, the researchers will randomly split the women into two groups:

• Sponsor Message

  one group will be given educational materials about aromatase inhibitors and joint pain

• Sponsor Message

  the other group will be given the same educational materials, but will also have access to an online pain coping skills training program

The online training program is made up of eight interactive sessions. Each session takes 35 to 45 minutes to complete, and participants can take breaks during the sessions and review them at any time after completing them.

Women are eligible for the study if they:

• Sponsor Message

  are post-menopausal

• Sponsor Message

  have been diagnosed with early-stage hormone receptor-positive breast cancer, are taking an aromatase inhibitor after breast cancer surgery, and are having pain related to the aromatase inhibitor

Women are not eligible for the study if they:

1. Sponsor Message

   are post-menopausal because their ovaries have stopped working because of medicine, rather than from natural menopause

2. Sponsor Message

   completed chemotherapy or radiation therapy less than four weeks before joining this study

3. Sponsor Message

   have another active cancer, with the exception of non-melanoma skin cancer

4. Sponsor Message

   had surgery less than eight weeks before joining the study

Read the detailed eligibility requirements.

Neither the educational materials nor the online training program are known to cause any side effects.

The study is taking place at Northwestern University in Chicago, Ill., and at Duke University in Durham, NC.

Contact Christine Rini, PhD, by calling 312-503-7715 or emailing christine.rini@northwestern.edu, or Rahma Omar by calling 312-503-1725 or emailing Rahma.Omar@northwestern.edu.