All patients receive 10 acupuncture treatments over the course of 8 weeks.

Chemotherapy-induced Peripheral Neuropathy

Breast Cancer Female

Gynecologic Cancer

The manualized acupuncture treatment (AT) intervention will be designed by Dr. Budhathoki and Dr. Taylor-Swanson and administered by Dr. Budhathoki and members of Huntsman acupuncture team. Ten sessions of AT will be delivered: twice per week for 2 weeks, thereafter once per week for six weeks, with a total of 9 treatments during a two-month course. Each session will last 45-60 minutes, with acupuncture needles retained 30-40 minutes. A minimum of 8 treatments must be received by each participant with no more than 9 days' gap between treatments permitted. Concurrent medications are allowed as prescribed and will be tracked in the study and analyzed as potential confounders.
Participants in the study will undergo study interview and fMRI at the following two time points: within 9 days after baseline following enrollment and within one week of acupuncture treatment completion.

Acupuncture

Huntsman Cancer Institute

Acupuncture Treatment of Chemotherapy-Induced Peripheral Neuropathy in Women

Acupuncture Treatment of Chemotherapy-Induced Peripheral Neuropathy in Women With Breast or Gynecologic Cancers: Mechanisms of Action and Feasibility

Average of 2 eligible women per month to participate in the trial

70% or more participants comply with AT attendance defined as 8 or more of 10 AT sessions and complete both fMRI scans

Zero serious adverse events directly related to AT sessions

70% or more enrolled participants comply with data collection

Lisa J Taylor-Swanson

Assistant Professor

University of Utah

Paclitaxel 135 mg/m2 over 3 hrs on day 1 Carboplatin IP (AUC= 6.0) on day 1 Paclitaxel 60 mg/m2 IP on Day 8 Repeat q 21 days x 6 cycles
Pelvic 6MV Photon Beam Energy, or IMRT where appropriate 1.8 Gy Dose/FX Total Dose 45 Gy
High Dose Radiation (HDR) x 3, or IMRT where appropriate 5 Gy to 0.5cm Depth from the Vaginal Cylinder Surface Total Dose 15 Gy

Uterine Carcinoma

IV paclitaxel in combination with IP carboplatin

Paclitaxel/Carboplatin

Pelvic radiation therapy

Uterine Serous Carcinoma and Adjuvant Combined Intraperitoneal Chemotherapy and Radiation

A Pilot Phase II Trial of Intravenous Paclitaxel and Intraperitoneal Carboplatin/Taxol Followed by Radiation in Patients With Advanced Stage Uterine Serous Carcinoma

Number of patients with treatment-related adverse events as assessed by CTCAE v4.0

Feasibility will be assessed by: Treatment completion proportion - the proportion of participants who complete the IV paclitaxel/IP carboplatin followed by IP paclitaxel/RT regimen Screening ratio - the number of potential participants screened per enrolled participant

The questionnaires used are EORTC QLQ-C30. QOL will be assessed using the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30) version 3.0. To date, more than 2200 studies using QLQ-C30 have been registered. This 30-item summary score captures the dimension of physical well-being, functional well-being, and symptom scales.

Karin Shih

Principal Investigator

Northwell Health

During Week 1-18, subjects will be placed on open-label IP Carboplatin/IV Paclitaxel on Day 1, then administered IP Paclitaxel on Day 8. This will be repeated every 3 weeks for 6 cycles. A CT imaging scan will be performed after six cycles of chemotherapy, prior to radiation. Also, in Week 19-23, subjects will receive Pelvic radiation therapy (IMRT) if deemed necessary. Additionally, from Week 24-26, High Dose Radiation or IMRT will be used where appropriate.

uterine neoplasms/illamående

Acupuncture Treatment of Chemotherapy-Induced Peripheral Neuropathy in Women

Uterine Serous Carcinoma and Adjuvant Combined Intraperitoneal Chemotherapy and Radiation

Efficacy Study of Weekly Taxotere and Topotecan for Recurrent Gynecologic (GYN) Cancers

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