Acupuncture for Adolescent and Young Adult Cancer Patients: (AcuAYA)
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 7
- Primary Endpoint
- Enrollment rate
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 40 Years (Child, Adult)
- Sex
- Female
- Accepts 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 reports 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 64 following the completion of cytotoxic 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 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
Arms & Interventions
Acupuncture group
Participants in the acupuncture group will receive 12 acupuncture treatments over 12 weeks during the study.
Intervention: Acupuncture (Procedure)
Wait-list Control (WLC)
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.
Intervention: No Acupuncture (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Menses recovery(1 year)