Acupuncture for Menstrual Irregularities

Recruiting at 6 trial locations

Overseen By William Tap, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Ovarian suppression, Hormonal contraception

Disqualifiers: Metastatic cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you have not been using ovarian suppression medicine or hormonal contraception drugs within 3 months of enrollment or during the study period. If you are taking these medications, you would need to stop before joining the trial.

What data supports the effectiveness of the treatment Acupuncture for Menstrual Irregularities?

Research suggests that acupuncture may help improve menstrual frequency in women with polycystic ovary syndrome (PCOS), which is a condition that can cause irregular periods. While more data is needed, some studies indicate that acupuncture could positively affect menstrual rates and related hormones. ^{1 2 3 4 5}

Is acupuncture generally safe for humans?

Research shows that acupuncture is generally safe for humans, with some studies specifically looking at its safety for conditions like premenstrual syndrome and diminished ovarian reserve. However, like any treatment, there can be some risks, and adverse events have been reported, so it's important to discuss with a healthcare provider. ^{6 7 8 9 10}

How does acupuncture treatment for menstrual irregularities differ from other treatments?

Acupuncture for menstrual irregularities is unique because it uses specific points on the body to regulate the menstrual cycle by balancing the body's energy (qi) and blood flow, unlike conventional hormonal therapies. It can also improve menstrual symptoms by influencing the neuroendocrine system, which is not a focus of standard drug treatments. ^{3 10 11 12 13}

Research Team

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for individuals who have experienced period loss due to chemotherapy. Participants should be dealing with menstrual irregularities or disorders as a result of their cancer treatment.

Inclusion Criteria

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

I was having regular periods when I was diagnosed.

Exclusion Criteria

Had been pregnant or lactating within 3 months prior to enrollment

My cancer has spread to other parts of my body.

I have had a hysterectomy or oophorectomy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the acupuncture group will receive 12 acupuncture treatments over 12 weeks

12 weeks

12 visits (in-person)

Wait-list Control

Participants in the wait-list control group will wait for 16 weeks before having the option to receive acupuncture treatment

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including menses recovery

1 year

Treatment Details

Interventions

• Acupuncture

Trial Overview The study is testing the effectiveness of acupuncture in treating amenorrhea caused by chemotherapy. It will measure participant enrollment and completion rates, time taken for menstrual cycles to return, and impacts on symptoms and quality of life.

Participant Groups

Group I: Acupuncture group Experimental Treatment 1 Intervention

Participants in the acupuncture group will receive 12 acupuncture treatments over 12 weeks during the study.

Group II: Wait-list Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

Acupuncture has a relatively low risk of adverse events (AEs), with at least one AE occurring in about 9.31% of patients undergoing treatment, and serious adverse events (SAEs) being very rare at approximately 1.01 per 10,000 patients.

The most common minor AEs are mild reactions such as bleeding or pain at the needle site, which are often considered intended effects of acupuncture, highlighting the need for standardized assessment tools to differentiate between adverse reactions and therapeutic responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. Bäumler, P., Zhang, W., Stübinger, T., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of acupuncture on menstrual frequency in women with polycystic ovary syndrome: Protocol for a randomized, controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Acupuncture for polycystic ovarian syndrome: A systematic review and meta-analysis. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[Acupuncture artificial menstrual cycle method for abnormal uterine bleeding-ovulatory dysfunction (spleen deficiency syndrome)]. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of acupuncture in polycystic ovary syndrome: A systematic review and meta-analysis of randomized controlled trials. [2020]

5. China pubmed.ncbi.nlm.nih.gov

Acupuncture for treating polycystic ovary syndrome: guidance for future randomized controlled trials. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. [2021]

7. China pubmed.ncbi.nlm.nih.gov

[Acupuncture with regulating menstruation to promote pregnancy for diminished ovarian reverse: a prospective case series study]. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Publication status and reporting quality of case reports on acupuncture-related adverse events: A systematic reviews of case studies. [2023]

9. China pubmed.ncbi.nlm.nih.gov

[Evaluation of clinical therapeutic effects and safety of acupuncture treatment for premenstrual syndrome]. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Acupuncture treatment for dysfunctional uterine bleeding in an adolescent. [2018]

11. China pubmed.ncbi.nlm.nih.gov

[Considerations about Acupuncture Treatment during Menstruation]. [2016]

12. China pubmed.ncbi.nlm.nih.gov

[Artificial cycle therapy of acupuncture and moxibustion for irregular menstruation]. [2015]

13. China pubmed.ncbi.nlm.nih.gov

[Analysis on the interrelation between acupuncture-induced weight reduction and menstruation]. [2016]