Clinical trial NCT05458284: The Effect of Acupuncture on Nerve Pain Caused by Taxane (Chemotherapy) Treatment
Official title: Acupuncture for Taxane-Induced Peripheral Neuropathy Prevention (ATP): A Phase II Randomized, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Taxane-Induced Peripheral Neuropathy
Keywords: Acupuncture
Peripheral Neuropathy
22-197
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Gateway for Cancer Research
First posted: 2022-07-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Some people experience a side effect while they are receiving taxane called taxane-induced peripheral neuropathy (TIPN). TIPN is pain in the arms and legs due to nerve damage caused by cancer treatment and may interfere with quality of life. The purpose of this study is to learn if acupuncture can prevent TIPN from getting worse. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body. We will compare real acupuncture (RA) to placebo (sham) acupuncture (SA). SA is done like RA, but will use different needles and target different sites or places on the body than RA. We are comparing RA to SA to learn whether RA can prevent TIPN from getting worse while receiving taxane.

Detailed description: The study will include two phases. The first phase is the screening phase, in which patients with early stage breast cancer undergoing taxane therapy will consent and receive TIPN screening each week till they develop grade 1 or higher by CTCAE criteria. The patients with TIPN grade 1 or higher will then be consented to the intervention phase, in which patients will be randomized to receive either weekly real or sham acupuncture treatment using a standardized, semi-fixed protocol developed in our preliminary studies to improve TIPN pain. The participant may also participate in Part 2 of the study if they begin to experience TIPN but do not participate in Part 1.

Eligibility criteria: Inclusion Criteria:

Screening Phase:

* English or Spanish-proficient men and women aged ≥18 years
* Histological diagnoses of invasive carcinoma of the breast
* Plan to receive curative intent chemotherapy regimen containing 12 weeks weekly paclitaxel or nab-paclitaxel as standard of care

Intervention Phase:

* TIPN grade ≥1 based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, developed while receiving taxane
* ≥ 4 4 weeks of either weekly paclitaxel or nab-paclitaxel, or paclitaxel or abraxane with dosing every 2-3 weeks planned, as standard of care and at treating physician's discretion
* Willing to adhere to requirement that no new pain medication or dose changes be taken throughout the first 12 weeks of the study period
* Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments

Exclusion Criteria:

Screening Phase:

* Pre-existing peripheral neuropathy within 28 days of screening consent
* Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine

Intervention Phase:

* Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine
* Use of acupuncture for symptom management within 28 days of intervention consent

Primary outcomes:
measure: Neuropathic Pain Scale (NPS)
timeFrame: at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk- Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jun Mao, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: