Breast Cancer
Conditions
Keywords
Breast Expanders
Brief summary
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.
Interventions
OTHERImmediate Post Operative Acupuncture Treatment
acupuncture treatment immediately after surgery (twice a week for 6 weeks)
OTHERNo Acupuncture Treatment
no acupuncture treatment for 6 weeks, but offered acupuncture at the end of the 6 week study period.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shoulder Tightness Score on Pain and Discomfort Assessment Questionnaire | 6 Weeks |
| Chest Tightness Score on Pain and Discomfort Assessment Questionnaire | 6 Weeks |
| General Pain Score on Pain and Discomfort Assessment Questionnaire | 6 Weeks |
Countries
United States
Outcome results
None listed