Ignite Creation Date:
2024-05-06 @ 2:04 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04205786
Status:
WITHDRAWN
Last Update Posted:
2024-06-24
First Post:
2019-12-18
Brief Title:
Vitamin B12 for Aromatase Inhibitors Associated Musculoskeletal Symptoms in Breast Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Randomized Study of Oral Vitamin B12 for the Treatment of Aromatase Inhibitors AI-Associated Musculoskeletal Symptoms AIMSS in Women With Early Stage Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Logistics requirements research cancelled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 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
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 11 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
Detailed Description:
According to the American Cancer Society there were more than 250000 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 40000 women are affected by this toxicity in the United States annually and up to 20000 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
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 40000 women are affected by this toxicity in the United States annually and up to 20000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None