CancerPhase 2NCT06915116
Acupuncture for People Experiencing Period Loss Due to Chemotherapy
A Phase 2 study testing Acupuncture and No Acupuncture in people with Cancer and Period Problem, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 40 years, women only
- Conditions the study is for
- Cancer, Period Problem
- What is being tested?
- Acupuncture and No Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- 31 Mar 2025to 31 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- English speaking woman between the ages of 15 and 40
- History of stage I, II, or III cancer OR stage IV or unstaged hematologic malignancy (e.g. lymphoma, leukemia, myeloma) that is stable, as assessed by care team
- Premenopausal status with regular menstruation at the time of diagnosis by patient report
- Completed cytotoxic chemotherapy within the past year
- Premenopausal status with regular menstruation at the time of diagnosis by patient report for females ages 18 or older
- Report cessation of menses during or after chemotherapy and have not experienced menses recovery at the time of enrollment.
Show all 11Show fewer
- Have reached menarche prior to therapy or during therapy for females between 15 and 17 years old
- Patient meets at least one of the following:
- Reports cessation of menses during or after chemotherapy and have not experienced menses recovery at the time of enrollment and has been without menses for at least 3 months 64 following the completion of cytotoxic chemotherapy; OR
- Is receiving ovarian suppression therapy (e.g., leuprolide [Lupron] or goserelin [Zoladex]) or hormonal contraceptive drugs, regardless of menstrual status, and report persistent (≥3 months), moderate-to- severe menopause-related symptoms, defined as a score of ≥4 on a 0-10 scale for at least one MENQOL item during eligibility screening.
- Willing to adhere to all study-related procedures, including randomization to one of the two possible arms: acupuncture and WLC
Who cannot join
- Had been pregnant or lactating within 3 months prior to enrollment
- History of hysterectomy or bilateral 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
William Tap, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Jun Mao, MD, MSCE, 646-608-8553
- Recruiting
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York, 11725
Jun Mao, MD, MSCE, 646-608-8553
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
East White Plains, New York, 10604
Jun Mao, MD, MSCE, 646-608-8553
- Recruiting
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748
Jun Mao, MD, MSCE, 646-608-8553
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Jun Mao, MD, MSCE, 646-608-8553
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Jun Mao, MD, MSCE, 646-608-8553
William Tap, MD, 646-888-4163
- Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, 11553
Jun Mao, MD, MSCE, 646-608-8553
About this study
Official title: Acupuncture for Adolescent and Young Adult Cancer Patients: (AcuAYA)
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.
- Conditions
- Cancer, Period Problem
- Being tested
- Acupuncture, No Acupuncture
- Keywords
- Acupuncture, Stage I cancer, Stage II cancer, Stage III cancer, Period Loss Due to Chemotherapy
- Medical subject headings
- Neoplasms, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
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.
No AcupunctureOther
Will have the option to receive the same acupuncture treatment as the acupuncture group after a 16-week waiting period
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Participants in the acupuncture group will receive 12 acupuncture treatments over 12 weeks during the study. Receives: Procedure: Acupuncture |
| 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. Receives: Other: No Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: up to 16 weeks
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start31 Mar 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two arm randomized study.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Mao, MD, MSCE, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915116
- Sponsor's protocol ID
- 25-020
- Status last verified
- Aug 2026
- First submitted
- 1 Apr 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Adolescent and Young Adult Cancer Patients: (AcuAYA)
- ClinicalTrials.gov ID
- NCT06915116
- Acronym / sponsor ID
- 25-020
- Conditions
- Cancer, Period Problem
- Keywords
- Acupuncture, Stage I cancer, Stage II cancer, Stage III cancer, Period Loss Due to Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two arm randomized study.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Procedure: AcupunctureParticipants in the acupuncture group will receive 12 acupuncture treatments over 12 weeks during the study. |
| Wait-list Control (WLC) | Active comparator | Other: No AcupunctureParticipants 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. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- English speaking woman between the ages of 15 and 40
- History of stage I, II, or III cancer OR stage IV or unstaged hematologic malignancy (e.g. lymphoma, leukemia, myeloma) that is stable, as assessed by care team
- Premenopausal status with regular menstruation at the time of diagnosis by patient report
- Completed cytotoxic chemotherapy within the past year
- Premenopausal status with regular menstruation at the time of diagnosis by patient report for females ages 18 or older
Key exclusion criteria (5 listed)
- Had been pregnant or lactating within 3 months prior to enrollment
- History of hysterectomy or bilateral 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture 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. | Procedure or surgery | Acupuncture group |
| No AcupunctureWill have the option to receive the same acupuncture treatment as the acupuncture group after a 16-week waiting period | Other | Wait-list Control (WLC) |
Primary outcome
Enrollment rate
Time frame: 1 year
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).
Acupuncture treatment adherence rate.
Time frame: up to 16 weeks
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.
1 secondary outcome
Menses recovery
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Tap, MD contact
Jun Mao, MD, MSCE principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture and No Acupuncture in people with Cancer and Period Problem, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Mao, MD, MSCE (646-608-8553, maoj@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.