Acupuncture for People Experiencing Period Loss Due to Chemotherapy
NCT ID: NCT06915116
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-03-31
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Acupuncture group
Participants in the acupuncture group will receive 12 acupuncture treatments over 12 weeks during the study.
Acupuncture
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. 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.
Wait-list Control
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
No Acupuncture
Will have the option to receive the same acupuncture treatment as the acupuncture group after a 16-week waiting period
Interventions
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Acupuncture
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. 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.
No Acupuncture
Will have the option to receive the same acupuncture treatment as the acupuncture group after a 16-week waiting period
Eligibility Criteria
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Inclusion Criteria
* Premenopausal status with regular menstruation at the time of diagnosis by patient report
* Completed chemotherapy within the past year
* Report cessation of menses during or after chemotherapy and have not experienced menses recovery at the time of enrollment.
* Have been without menses for at least 3 months following the completion of chemotherapy
* Willing to adhere to all study-related procedures, including randomization to one of the two possible arms: acupuncture and WLC
Exclusion Criteria
* Had been pregnant or lactating within 3 months prior to enrollment
* History of hysterectomy or oophorectomy
* Ongoing or planned radiation or surgery within 4 months from randomization
* Use of acupuncture for menses recovery within 3 months of enrollment
* Had been or will be receiving ovarian suppression medicine, such as leuprolide (Lupron) and goserelin (Zoladex), or hormonal contraception drugs within 3 months of enrollment or during the study period
18 Years
39 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jun Mao, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, United States
Countries
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Central Contacts
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William Tap, MD
Role: CONTACT
Facility Contacts
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Jun Mao, MD, MSCE
Role: primary
Jun Mao, MD, MSCE
Role: primary
Jun Mao, MD, MSCE
Role: primary
Jun Mao, MD, MSCE
Role: primary
Jun Mao, MD, MSCE
Role: primary
Jun Mao, MD, MSCE
Role: primary
William Tap, MD
Role: backup
Jun Mao, MD, MSCE
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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25-020
Identifier Type: -
Identifier Source: org_study_id
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