Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Comprehensive and Integrative Medicine Institute of South Korea | OTHER |
Not provided
Not provided
Not provided
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental |
|
|
| Nature scenery videos with relaxation exercise | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | Standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline to week 12 |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Weidong Lu, MB, MPH, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nature scenery with a relaxation exercise | Other | Watch nature scenery videos with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions) |
|
| 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. | baseline to 12 Weeks |
| 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. | baseline to week 24 |
| 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. | pre-treatment, and at weeks 3, 6, 9, and 12 during the intervention up to 12 weeks |
| 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. | Baseline, Week 12, and Week 24 |
| 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. | Baseline, Week 12, and Week 24 |
| 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. | Baseline, Week 12, and Week 24 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided