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The purpose of this study is to find out whether it is practical (feasible) to use acupuncture to treat period loss (amenorrhea) caused by chemotherapy treatment in people with cancer. The researchers will look at how many participants enroll and complete the study. The researchers will also study how treatment with acupuncture affects the amount of time for the menstrual cycle to return and symptoms and quality of life related to amenorrhea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture group | Experimental | Participants in the acupuncture group will receive 12 acupuncture treatments over 12 weeks during the study. |
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| Wait-list Control (WLC) | Active Comparator | Participants in the wait-list control group will be put on a wait-list and have the option to receive the same acupuncture treatment as the acupuncture group after a 16-week waiting period. The 16-week waiting period will begin on the day that the WLC participant completes their baseline lab draw. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Acupuncture will be delivered by licensed experienced acupuncturists at MSK. The intervention includes 12 treatments of acupuncture over 12 weeks (i.e. one treatment a week) with a +/- 14-day window. This window applies to the 12-week treatment period rather than to individual visits. The minimum required time between each treatment is 48 hours. When patients experience menses recovery during the treatment period, they have the option to discontinue treatment or continue receiving up to 12 acupuncture sessions for symptom management over 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rate | This is the proportion of patients who enroll in the study among those who are eligible and offered participation. Reason for not participating will be documented (e.g. time/commitment, not wanting to be randomized, does not want the study intervention). | 1 year |
| Acupuncture treatment adherence rate. | adherence rate is the proportion of patients randomized to the Acupuncture arm who are treatment adherent, defined as completing 10 or more of the 12 acupuncture sessions. | up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Menses recovery | Upon the return of menstruation, participants will inform to their CRCs. The CRCs will then send them the Bleeding Diary which is a link provided through REDCap to record the date and characteristics of their menses. They will be required to fill out this link daily until the menstrual cycle concludes | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Menses recovery
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Mao, MD, MSCE | Contact | 646-608-8553 | maoj@mskcc.org | |
| William Tap, MD | Contact | 646-888-4163 |
| Name | Affiliation | Role |
|---|---|---|
| Jun Mao, MD, MSCE | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008599 | Menstruation Disturbances |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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This is a two arm randomized study.
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| No Acupuncture | Other | Will have the option to receive the same acupuncture treatment as the acupuncture group after a 16-week waiting period |
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| Memorial Sloan Kettering Monmouth (All protocol activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
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| Memorial Sloan Kettering Bergen (All Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
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| Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) | Recruiting | Commack | New York | 11725 | United States |
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| Memorial Sloan Kettering Westchester (All Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
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| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
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| Memorial Sloan Kettering Nassau (All Protocol Activities) | Recruiting | Rockville Centre | New York | 11553 | United States |
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