Clinical Trial Details
— Status: Suspended
Administrative data
NCT number |
NCT04205786 |
Other study ID # |
CASE5119 |
Secondary ID |
|
Status |
Suspended |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 12, 2021 |
Est. completion date |
June 1, 2025 |
Study information
Verified date |
March 2024 |
Source |
Case Comprehensive Cancer Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Treatment of hormone receptor (HR)-positive breast cancer with Aromatase Inhibitors (AIs) can
lead to associated musculoskeletal pain and may cause patients to discontinue important
treatment.
This is a randomized controlled trial assessing the affect of Vitamin B12 on AI-associated
joint pain and other outcomes. Participants will be randomly assigned 1:1 to treatment or
control arm.
The primary objective of this study is:
-To assess whether daily oral Vitamin B12 decreases average joint pain in women with
AI-Associated Musculoskeletal Symptoms
Secondary objectives include:
- To investigate whether daily vitamin B12 improves functional quality of life
- To explore the impact of treatment on serum inflammatory cytokine levels (C- reactive
protein) between baseline and various points in treatment.
Description:
According to the American Cancer Society, there were more than 250,000 new breast cancer
cases in 2017. Incidence of breast cancer increases with age, with more than 75% of patients
being postmenopausal at the time of diagnosis. In addition, hormone receptors (HR) are over
expressed in the majority of breast cancer tumors in postmenopausal women.
Two classes of anti-endocrine therapies are used for treatment of HR-positive breast cancer:
tamoxifen and the AIs, which can only be used to treat postmenopausal women because they are
ineffective in women with functional ovaries. Joint pain is a significant AI-associated
toxicity, affecting as many as 50% of patients. No factors associated with breast cancer
treatment (such as chemotherapy) or co-morbid conditions (such as diabetes or body mass
index) have been clearly shown to be predictive of the development of joint pain. The cause
of AI-associated musculoskeletal symptoms remains elusive but some think it is associated
with the direct effects of estrogen deprivation on bone, neurohormonal changes which result
in change in pain sensitivity, and immune system changes that alter the circulating or local
inflammatory cytokine concentrations.
Some studies report more than 20% of patients are no longer taking their AI chemotherapy
regimen because of AI-associated joint pain. As many as 40,000 women are affected by this
toxicity in the United States annually and up to 20,000 women discontinue AI therapy because
of intolerable joint pain and muscle aches. The current treatment for AI associated
musculoskeletal symptoms is limited to oral pain medications and exercise, but, neither
intervention has optimal effects, and the long term use of oral pain medication is
problematic. Improvement in the treatment of AI associated musculoskeletal symptoms is needed
to improve compliance with therapy, and thereby lead to improved breast cancer outcomes and
survivorship.
The study team conducted a pilot study (Campbell et al. Breast J, 2018) which suggested that
vitamin B12 reduces pain and improves quality of life for participants taking aromatase
inhibitors (AIs) who experienced AI-related musculoskeletal symptoms. This study aims to
confirm these results in a phase III randomized prospective trial. If confirmed, Vitamin B12
would become a safe and cost-effective option for the treatment of AI-related musculoskeletal
symptoms, leading to improved cancer outcomes and survivorship.