Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Breast Neoplasms

Peripheral Nervous System Diseases

Breast Diseases

Skin Diseases

Neuromuscular Diseases

Antineoplastic Agents

All Drugs and Chemicals

Taxane

* Breast cancer patients will be recruited who are scheduled to receive taxane-based chemotherapy (with or without anti-HER2 therapy) and who have no neuropathic symptoms at baseline.

  40 participants will be randomized into the acupuncture Arm:
* The acupuncture arm will receive a standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions).

* Breast cancer patients will be recruited who are scheduled to receive taxane-based chemotherapy (with or without anti-HER2 therapy) and who have no neuropathic symptoms at baseline.

  40 Participants will be randomized into the Control Arm:
* The control arm will receive and watch videos with nature scenery with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions)

Standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions).

Acupuncture

Watch nature scenery videos with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions)

Nature scenery with a relaxation exercise

Weidong Lu, MB,MPH, PhD

Anna M Tanasijevic

Ellie Diederich

Weidong Lu, PhD, MPH

Weidong Lu, MB, MPH, PhD

This research is being done to determine whether acupuncture can help prevent or lessen chemotherapy-induced peripheral neuropathy (CIPN), a side effect of some kinds of chemotherapy that causes pain, numbness, tingling, swelling, or muscle weakness mostly in the hands or feet.

This research will also help determine whether acupuncture can improve quality of life in patients receiving taxane-based chemotherapy for the treatment of breast cancer.

The names of the study activities involved in this study are/is:

* Acupuncture treatments for participants in the Acupuncture Group
* Nature videos with a relaxation exercise for participants in the Relaxation/ Exercise Group

The Comprehensive and Integrative Medicine Institute (CIMI) of South Korea is supporting this research study by providing funding.

This study randomly assigns patients with breast cancer who are starting a chemotherapy program that includes a Taxane to one of two groups:

* The Acupuncture Group will receive acupuncture treatments for 12 weeks during chemotherapy treatment.
* The Relaxation Exercise Group will receive a program of weekly videos accompanied by a relaxation exercise. Both programs will last 12 weeks.

Participants will be asked to complete questionnaire 12 weeks after the completion of the acupuncture or relaxation exercise program, so participants be on this research study for up to 24 weeks (6 months).

It is expected that about 80 people will take part in this research study.

Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial)

Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture, A Randomized Controlled Trial (PACT Trial)

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The primary endpoint is the change in severity of CIPN, defined as the average change from baseline (12-week to baseline) in the EORTC Quality of Life - Chemotherapy Induced Neuropathy 20 (QLQ-CIPN20) sensory subscale score (9 items). Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. A higher score means greater severity of CIPN. The total and three domain scores are calculated and linearly transformed into 0-100 scales according to the scoring manual. A score of 100 indicates the worst CIPN symptom.

AOCIPN is defined as an increase of 2.5 points or larger in the QLQ-CIPN 20 sensory score at any time point relative to baseline or reported "mild" or "a little bit" or higher in PRO-CTCAE CIPN "Severity" and "Interference" items during the study intervention period (baseline to week 12).

G2CIPN is defined a 20-point or greater increase from baseline at any time point in QLQ-CIPN20 total score or grade-2 in PRO-CTCAE CIPN, which is defined as reporting the severity of numbness and/or tingling AND interference of with daily activities ≥ 1 (mild/ a little bit) during the study period at any time point.

Received or relative dose intensity (RDI) refers to the amount and timing of chemotherapy actually delivered versus the expected dose and schedule. The relative dose intensity (RDI) will be calculated for each participant and compared between treatment arms using two-sample t-tests or Wilcoxon rank-sum tests, depending upon normality of the data.

Maximum CIPN score will be assessed through the EORTC Quality of Life - Chemotherapy Induced Neuropathy 20 (QLQ-CIPN20) sensory subscale score (9 items). Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. A higher score means greater severity of CIPN. The maximum CIPN sensory score change (post-pre) for each patient during the intervention will be compared between the randomized treatment arms.

CIPN pain intensity will be measured using a past 7 days, 0-10 numerical rating scale diary. A higher score indicates greater pain intensity.

The PSQI is a 19-item self-reported questionnaire that assesses sleep quality for the preceding month. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

Quality of life and cancer treatment-related symptoms will be assessed using the EORTC-QLQ-C30. The QLQ-C30 consists of 30 items that are grouped within global health status/quality of life (1 - 7 points, higher scores = greater quality of life), functional (e.g., physical or cognitive; 0 - 100 transformed scores, higher = better function), or symptom (e.g., insomnia, fatigue; 0 - 100 transformed scores, higher = worse symptoms) subscales.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial)	NCT05528263	Acupuncture Early-stage Bre... Chemotherapy-in... Breast Cancer S... Breast Cancer S... Breast Cancer S...	Acupuncture Nature scenery ...	18 Years -	Dana-Farber Cancer Institute
Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial)	NCT05528263	Acupuncture Early-stage Bre... Chemotherapy-in... Breast Cancer S... Breast Cancer S... Breast Cancer S...	Acupuncture Nature scenery ...	18 Years -	Dana-Farber Cancer Institute
Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial)	NCT05528263	Acupuncture Early-stage Bre... Chemotherapy-in... Breast Cancer S... Breast Cancer S... Breast Cancer S...	Acupuncture Nature scenery ...	18 Years -	Dana-Farber Cancer Institute

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