Cancer, Period Problem
Conditions
Keywords
Acupuncture, Stage I cancer, Stage II cancer, Stage III cancer, Period Loss Due to Chemotherapy
Brief 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. 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.
Interventions
PROCEDUREAcupuncture
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.
OTHERNo Acupuncture
Will have the option to receive the same acupuncture treatment as the acupuncture group after a 16-week waiting period
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a two arm randomized study.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 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. * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment rate | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menses recovery | 1 year | 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 |
Countries
United States
Contacts
CONTACTJun Mao, MD, MSCE
CONTACTWilliam Tap, MD
PRINCIPAL_INVESTIGATORJun Mao, MD, MSCE
Memorial Sloan Kettering Cancer Center
Outcome results
None listed