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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether acupuncture can restore menstrual cycles in women who lost their periods due to chemotherapy. Researchers aim to determine the number of participants who join and complete the study, and how acupuncture affects the time for periods to return, along with related symptoms and quality of life. Women under 40 who had regular periods before cancer treatment, completed chemotherapy in the past year, and have not had their period return for at least 3 months may be suitable for this trial. Participants will either receive acupuncture treatments over 12 weeks or be placed on a wait-list with the option for treatment after 16 weeks. As a Phase 2 trial, this study measures how well acupuncture works in an initial, smaller group, offering participants a chance to contribute to important research.

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 prior data suggests that acupuncture is safe for treating menstrual irregularities?

Research has shown that acupuncture is generally safe for treating menstrual problems. In a study on painful periods, acupuncture was well-tolerated, with a low chance of serious side effects. The odds ratio was 0.62, indicating minimal risk. Another analysis on irregular periods also supports acupuncture's effectiveness and safety.

These findings suggest that acupuncture is a reliable option with few negative effects. For those considering joining a trial for acupuncture, the safety data is reassuring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for menstrual irregularities, such as hormonal therapies and medications, acupuncture offers a natural and non-invasive approach. Researchers are excited about acupuncture because it may help regulate menstrual cycles by stimulating specific points on the body, potentially improving blood flow and hormonal balance. Plus, it's a drug-free alternative, which means fewer side effects and a holistic way to support women's health. This makes acupuncture a promising option for those seeking a different path to wellness without relying on pharmaceuticals.

What evidence suggests that acupuncture might be an effective treatment for amenorrhea?

Research has shown that acupuncture might help with irregular periods. One study found that acupuncture improved the frequency of periods in women with polycystic ovary syndrome (PCOS). Another study demonstrated that acupuncture could lower stress and increase blood flow in the pelvic area, aiding in period regulation. Additionally, combining acupuncture with Chinese herbs proved 80.6% effective in improving hormonal and menstrual issues. In this trial, participants in the acupuncture group will receive 12 acupuncture treatments over 12 weeks. These findings suggest that acupuncture could be a promising option for managing irregular periods, including those caused by chemotherapy. ^{1 2 6 7 8}

Who Is on the Research Team?

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5708987/

Efficacy of acupuncture on menstrual frequency in women ... A systematic review revealed that there was an improvement in the menstrual frequency of PCOS patients after acupuncture treatment. However, menstrual frequency ...

2. journals.lww.com journals.lww.com/md-cases/fulltext/2021/12000/efficacy_and_safety_of_acupuncture_for_irregular.12.aspx

Efficacy and safety of acupuncture for irregular menstruation It could reduce stress, improve blood flow in the pelvic area, and thicken the endometrium to improve menstrual cycle. However, acupuncture treatments in most ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3962314/

Acupuncture and women's health: an overview of the role of ... The results demonstrated a total effectiveness rate of 93.8% on hormonal and menstrual measures in the combined acupuncture and Chinese herb group, and 80.6% in ...

4. dovepress.com dovepress.com/long-term-effects-of-acupuncture-for-primary-dysmenorrhea-a-systematic-peer-reviewed-fulltext-article-JPR

Long Term Effects of Acupuncture for Primary Dysmenorrhea Acupuncture resulted in profound improvements in CMSS compared with SA at 1 menstrual cycle post-treatment (MD −7.11; 95% CI −8.46 to ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07023926

NCT07023926 | The Efficacy and Safety of Acupuncture for ... have experienced ≥3 headache days during each menstrual cycle (days -2 to +3) and ≥5 total headache days per cycle over the past 3 months and baseline period; ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06915116

Acupuncture for People Experiencing Period Loss Due to ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12527671/

Long Term Effects of Acupuncture for Primary Dysmenorrhea The pooled data showed that acupuncture was a safe treatment (OR: 0.62; 95% CI 0.16 to 2.44; p = 0.4922). Sensitivity Analysis. In comparison ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032723011941

Acupuncture's long-term impact on depression prevention ... A large cohort study compares acupuncture users and non-users with primary dysmenorrhea, showing reduced depression risk.