Ignite Creation Date:
2024-05-05 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00641303
Status:
COMPLETED
Last Update Posted:
2023-05-08
First Post:
2008-03-21
Brief Title:
Acupuncture in Reducing Muscle and Bone Symptoms in Women Receiving Letrozole Exemestane or Anastrozole for Stage 0 Stage I Stage II or Stage III Breast Cancer
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Multi-Center Randomized Controlled Double Blind Trial Assessing the Effect of Acupuncture in Reducing Musculoskeletal Symptoms in Breast Cancer Patients Taking Aromatase Inhibitors
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Acupuncture may help relieve muscle and bone pain caused by aromatase inhibitor therapy such as letrozole exemestane and anastrozole
PURPOSE This randomized phase II trial is studying acupuncture to see how well it works in reducing muscle and bone symptoms in women receiving letrozole exemestane or anastrozole for stage 0 stage I stage II or stage III breast cancer
PURPOSE This randomized phase II trial is studying acupuncture to see how well it works in reducing muscle and bone symptoms in women receiving letrozole exemestane or anastrozole for stage 0 stage I stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
Primary
To determine if acupuncture can reduce aromatase inhibitor AI-associated musculoskeletal symptom severity in terms of function and pain in woman with stage 0-III breast cancer
Secondary
To assess if acupuncture decreases oral analgesic use in these patients
To assess if acupuncture decreases the proportion of patients who change or discontinue AI therapy
To assess if acupuncture improves menopausal symptoms mood ie depression or anxiety sleep quality and sleep disturbance and overall quality of life of these patients
To assess if acupuncture changes plasma concentrations of estrogens ie E1 E2 and E1S cytokine profile and beta endorphin
OUTLINE This is a multicenter study Patients are stratified according to participation in the aromatase inhibitor trial A Multicenter Randomized Clinical Trial Correlating the Effects of 24 Months of Exemestane or Letrozole on Surrogate Markers of Response With Aromatase Polymorphism yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I control Patients receive 8 weekly sessions of sham acupuncture treatment comprising 20 minutes of a non-penetrating device consisting of a retractable needle and an adhesive tube on the skin using the Park Sham Device PSD in 14 non-acupuncture points Patients may receive 4 free acupuncture sessions not sham after the 12-week previously 24-week follow-up visit
Arm II treatment Patients receive 8 weekly sessions of acupuncture treatment comprising 20 minutes of needle insertion in 15 acupuncture points including CV 4 CV 6 CV12 and bilateral LI 4 MH 6 GB 34 ST 36 KI 3 BL 65
Quality of life is assessed periodically to measure changes in symptoms that may be related to hot flashes and estrogen deprivation ie menopausal symptoms mood depression and anxiety sleep quality and overall quality of life using the menopausal symptoms checklist the Hot Flash Related Daily Interference Scale HFRDI and the Hot Flash Daily Diary the Pittsburgh Sleep Quality Index PSQI the Center for Epidemiologic Studies Depression Scale CESD the Hospital Anxiety and Depression Scale HADS-A and the EuroQOL
Patients complete questionnaires including the Health Assessment Questionnaire HAQ and visual analog scales VAS to assess both pain and global health status at baseline after 4 and 8 weeks of acupuncture or sham acupuncture and at follow-up at 12 weeks previously 24 weeks The average amount of daily oral analgesic usage is assessed at weeks 0 4 8 and 12previously 24
Patients undergo blood sample collection periodically for correlative studies Samples are analyzed for plasma concentrations of estrogen ie estrone E1 estradiol E2 and estrone sulfate E1S via HPLC-MSMS level of 35 serum cytokines via addressable laser bead immunoassay ALBIA or classical sandwich ELISA cytokines and their soluble receptors via classical sandwich ELISA techniques and Beta-endorphin via competitive ELISA
All patients are followed for 12 weekspreviously 24 weeks Patients in arm I may be followed for an additional 4 weeks if they choose to receive the free acupuncture sessions
Primary
To determine if acupuncture can reduce aromatase inhibitor AI-associated musculoskeletal symptom severity in terms of function and pain in woman with stage 0-III breast cancer
Secondary
To assess if acupuncture decreases oral analgesic use in these patients
To assess if acupuncture decreases the proportion of patients who change or discontinue AI therapy
To assess if acupuncture improves menopausal symptoms mood ie depression or anxiety sleep quality and sleep disturbance and overall quality of life of these patients
To assess if acupuncture changes plasma concentrations of estrogens ie E1 E2 and E1S cytokine profile and beta endorphin
OUTLINE This is a multicenter study Patients are stratified according to participation in the aromatase inhibitor trial A Multicenter Randomized Clinical Trial Correlating the Effects of 24 Months of Exemestane or Letrozole on Surrogate Markers of Response With Aromatase Polymorphism yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I control Patients receive 8 weekly sessions of sham acupuncture treatment comprising 20 minutes of a non-penetrating device consisting of a retractable needle and an adhesive tube on the skin using the Park Sham Device PSD in 14 non-acupuncture points Patients may receive 4 free acupuncture sessions not sham after the 12-week previously 24-week follow-up visit
Arm II treatment Patients receive 8 weekly sessions of acupuncture treatment comprising 20 minutes of needle insertion in 15 acupuncture points including CV 4 CV 6 CV12 and bilateral LI 4 MH 6 GB 34 ST 36 KI 3 BL 65
Quality of life is assessed periodically to measure changes in symptoms that may be related to hot flashes and estrogen deprivation ie menopausal symptoms mood depression and anxiety sleep quality and overall quality of life using the menopausal symptoms checklist the Hot Flash Related Daily Interference Scale HFRDI and the Hot Flash Daily Diary the Pittsburgh Sleep Quality Index PSQI the Center for Epidemiologic Studies Depression Scale CESD the Hospital Anxiety and Depression Scale HADS-A and the EuroQOL
Patients complete questionnaires including the Health Assessment Questionnaire HAQ and visual analog scales VAS to assess both pain and global health status at baseline after 4 and 8 weeks of acupuncture or sham acupuncture and at follow-up at 12 weeks previously 24 weeks The average amount of daily oral analgesic usage is assessed at weeks 0 4 8 and 12previously 24
Patients undergo blood sample collection periodically for correlative studies Samples are analyzed for plasma concentrations of estrogen ie estrone E1 estradiol E2 and estrone sulfate E1S via HPLC-MSMS level of 35 serum cytokines via addressable laser bead immunoassay ALBIA or classical sandwich ELISA cytokines and their soluble receptors via classical sandwich ELISA techniques and Beta-endorphin via competitive ELISA
All patients are followed for 12 weekspreviously 24 weeks Patients in arm I may be followed for an additional 4 weeks if they choose to receive the free acupuncture sessions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GCC 0930 | OTHER | University of Maryland Greenebaum Cancer Center | httpsreporternihgovquickSearchP30CA006973 |
| P30CA006973 | NIH | None | None |
| JHOC-J07110 | None | None | None |
| SKCCC J07110 | None | None | None |
| JHOC-NA_00013024 | None | None | None |