Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders
Status
Withdrawn
Conditions
Breast Cancer
Treatments
Other: No Acupuncture Treatment
Other: Immediate Post Operative Acupuncture Treatment
Details and patient eligibility
About
The primary purpose of this study is to evaluate changes in shoulder tightness, chest tightness, and general pain related to post-mastectomy reconstructive surgery with tissue expansion in women who are randomized to receive acupuncture treatment immediately after surgery (twice a week for 6 weeks) compared to those who are randomized to no acupuncture treatment for 6 weeks, but offered acupuncture at the end of the 6 week study period.
Sex
Female
Ages
18 to 79 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Women who are newly diagnosed with breast cancer, enrolled in the The Breast Cancer Database of NYU Cancer Center (BCD) and who are having breast cancer surgery involving a mastectomy procedure with insertion of a tissue expander for reconstructive purposes
- Women who are newly diagnosed with breast cancer
- Women who are enrolled in the Breast Cancer Database (BCD)
- Women who are having breast cancer surgery involving a mastectomy procedure with insertion of a tissue expander for reconstructive purposes
Exclusion criteria
- Women who had neoadjuvant chemotherapy and/or radiation therapy, women who are currently on anticoagulant therapy, women who are having breast reconstruction with Alloderm, women who have chronic pre-operative pain, and/or women who have had a history of previous implants or prior augmentations
- Women who had neoadjuvant chemotherapy and/or radiation therapy
- Women who are currently on anticoagulant therapy
- Women who are having breast reconstruction with Alloderm
- Women who have chronic pre-operative pain
- Women who have had a history of previous implants or prior augmentations
- Women who are currently on anticoagulant therapy
- Women who are having breast reconstruction with Alloderm
- Women who have chronic pre-operative pain
- Women who have had a history of previous implants or prior augmentations
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
0 participants in 2 patient groups
Immediate Post Operative Acupuncture Treatment
Active Comparator group
Treatment:
Other: Immediate Post Operative Acupuncture Treatment
Acupuncture Treatment After 6 Weeks of Recovery
Active Comparator group
Treatment:
Other: No Acupuncture Treatment
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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