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

Primary Purpose

Acupuncture, Early-stage Breast Cancer, Chemotherapy-induced Peripheral Neuropathy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Nature scenery with a relaxation exercise
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acupuncture focused on measuring Acupuncture, Early-stage Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of histologically proven stage I-III breast cancer, without evidence of distant metastasis
  • Scheduled to receive adjuvant or neoadjuvant taxane-based chemotherapy (with or without HER-2 directed therapy or with or without immunotherapy). Patient must enroll before the second infusion of a taxane.
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Signed informed consent

Exclusion Criteria:

  • Previous receipt of CIPN-inducing chemotherapy agents (1 prior dose of a taxane is allowed).
  • Unstable cardiac disease or myocardial infarction within 6 months prior to study entry
  • Wearing a pacemaker or implantable cardioverter-defibrillator
  • Uncontrolled seizure disorder
  • History of pre-existing peripheral neuropathy
  • Use of acupuncture within the 3 months prior to study enrollment

  • Self-report of any CIPN symptoms via staff-administered PRO-CTCAE CIPN, defined as either:

    • Report of "mild", "moderate", "severe", "very severe" on the Severity Item on PRO-CTCAE CIPN assessment
    • Report of "a little bit", "somewhat", "quite a bit", "very much" on the Interfere Item on PRO-CTCAE CIPN assessment

Sites / Locations

  • Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture

Nature scenery videos with relaxation exercise

Arm Description

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)

Outcomes

Primary Outcome Measures

Change in severity of CIPN, defined by mean change in EORTC QLQ-CIPN20 sensory score
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.

Secondary Outcome Measures

Incidence of CIPN between intervention arms - AOCIPN
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).
Incidence of CIPN between intervention arms - G2CIPN
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.
Relative dose intensity (RDI)
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
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.
Changes in mean scores of pain intensity
CIPN pain intensity will be measured using a past 7 days, 0-10 numerical rating scale diary. A higher score indicates greater pain intensity.
Changes in the total mean scores of the Pittsburgh Sleep Quality Index (PSQI)
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.
Changes in the total and subscales of EORTC QLQ-C30
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.

Full Information

First Posted
August 29, 2022
Last Updated
December 21, 2022
Sponsor
Dana-Farber Cancer Institute
Collaborators
The Comprehensive and Integrative Medicine Institute of South Korea
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1. Study Identification

Unique Protocol Identification Number
NCT05528263
Brief Title
Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial)
Acronym
PACT
Official Title
Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture, A Randomized Controlled Trial (PACT Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2022 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
The Comprehensive and Integrative Medicine Institute of South Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Early-stage Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
Keywords
Acupuncture, Early-stage Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
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).
Arm Title
Nature scenery videos with relaxation exercise
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
Standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions).
Intervention Type
Other
Intervention Name(s)
Nature scenery with a relaxation exercise
Intervention Description
Watch nature scenery videos with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions)
Primary Outcome Measure Information:
Title
Change in severity of CIPN, defined by mean change in EORTC QLQ-CIPN20 sensory score
Description
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.
Time Frame
baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Incidence of CIPN between intervention arms - AOCIPN
Description
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).
Time Frame
baseline to week 12
Title
Incidence of CIPN between intervention arms - G2CIPN
Description
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.
Time Frame
baseline to 12 Weeks
Title
Relative dose intensity (RDI)
Description
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.
Time Frame
baseline to week 24
Title
Maximum CIPN score
Description
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.
Time Frame
pre-treatment, and at weeks 3, 6, 9, and 12 during the intervention up to 12 weeks
Title
Changes in mean scores of pain intensity
Description
CIPN pain intensity will be measured using a past 7 days, 0-10 numerical rating scale diary. A higher score indicates greater pain intensity.
Time Frame
Baseline, Week 12, and Week 24
Title
Changes in the total mean scores of the Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Baseline, Week 12, and Week 24
Title
Changes in the total and subscales of EORTC QLQ-C30
Description
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.
Time Frame
Baseline, Week 12, and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of histologically proven stage I-III breast cancer, without evidence of distant metastasis Scheduled to receive adjuvant or neoadjuvant taxane-based chemotherapy (with or without HER-2 directed therapy or with or without immunotherapy). Patient must enroll before the second infusion of a taxane. Age ≥ 18 years Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Signed informed consent Exclusion Criteria: Previous receipt of CIPN-inducing chemotherapy agents (1 prior dose of a taxane is allowed). Unstable cardiac disease or myocardial infarction within 6 months prior to study entry Wearing a pacemaker or implantable cardioverter-defibrillator Uncontrolled seizure disorder History of pre-existing peripheral neuropathy Use of acupuncture within the 3 months prior to study enrollment Self-report of any CIPN symptoms via staff-administered PRO-CTCAE CIPN, defined as either: Report of "mild", "moderate", "severe", "very severe" on the Severity Item on PRO-CTCAE CIPN assessment Report of "a little bit", "somewhat", "quite a bit", "very much" on the Interfere Item on PRO-CTCAE CIPN assessment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weidong Lu, MB,MPH, PhD
Phone
(617) 632-3322
Email
Weidong_lu@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weidong Lu, MB, MPH, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna M Tanasijevic
Phone
617-632-5584
Email
anna_tanasijevic@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Ellie Diederich
Phone
617-632-5408
Email
Ellie_Diederich@DFCI.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
Weidong Lu, PhD, MPH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

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

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