Breast Cancer
Conditions
Keywords
Breast Cancer
Brief summary
This research study is evaluating acupuncture, a medical therapy in which hair-thin, stainless steel needles are shallowly inserted into specific points to help the body's natural healing process, as a possible treatment to reduce hot flashes.
Detailed description
Hot flashes are a sensation of sudden onset of body warmth, flushing and sweating. Hot flashes are common side effects of breast cancer treatments and can affect mood and daily life. Medications can help ease hot flashes, but many patients continue to experience symptoms despite these treatments. Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are inserted into various spots on the skin, with the goal of affecting body's natural healing system. Acupuncture has been tested in clinical trials in cancer patients and has been shown to be helpful in treating a number of side effects of cancer treatment, such as nausea and vomiting from chemotherapy. A few early studies have suggested that acupuncture may help to lessen hot flashes, but more information is needed about the benefits of acupuncture in breast cancer patients. This study is being done to test whether acupuncture can help to reduce the number and intensity of hot flashes in breast cancer patients who are being treated with mediations such as tamoxifen and aromatase inhibitors, such as anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara).
Interventions
DEVICEAcupuncture
Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are inserted into various spots on your skin, with the goal of affecting body's natural healing system
OTHERUsual Care
the current standard of care with non-hormonal pharmacotherapy of western medicine
Sponsors
Dana-Farber Cancer Institute
The Comprehensive and Integrative Medicine Institute of South Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of histologically or cytologically proven Stage I-III breast cancer with estrogen receptor positive with HER-2 positive or negative tumor; * Premenopausal or postmenopausal status; * Completed all primary chemotherapy and surgery; * Currently undergoing adjuvant hormonal therapy (e.g. Tamoxifen and/or Aromatase inhibitors) with or without ovarian function suppression for at least 4 weeks at study entry; the use of Trastuzumab after adjuvant chemotherapy is allowed; * Reported persistent hot flashes for at least 4 weeks AND more than 14 episodes of hot flashes per week (2 hot flashes per day) during the week prior to the study entry; * Age ≥ 18 years; * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Signed informed consent
Exclusion criteria
Undergoing chemotherapy or planned surgery, chemotherapy, change doses and regimen of hormonal therapy during the study period; * Unstable cardiac disease or myocardial infarction within 6 months prior to study entry; * Uncontrolled seizure disorder or history of seizure; * Active clinically significant uncontrolled infection; * Use of acupuncture for hot flashes within 6 months prior to the study entry; * Uncontrolled major psychiatric disorders, such as major depression or psychosis; * Newly starting pharmacologic treatment of hot flashes such as selective serotonin reuptake inhibitors (SSRIs) and/or anti-convulsant for less than 4 weeks prior to study entry. Participants may continue with medications or therapies for the treatment of hot-flashes while participating in the study if the medication has been taking for more than 4 weeks prior to study entry AND the dose of the medication is going to be kept consistently during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10 | 10 weeks | Daily Hot Flash Diary (DHFD) The DHFD is a measure of self-reported hot flash data that uses a diary to record the frequency and severity of hot flashes based on a 4-point scale (i.e., mild, moderate, severe, or very severe) to provide a hot flash score/index that reflects both number and severity of hot flashes (i.e., sum of the number of hot flashes multiplied by a weighted severity). Patients were asked to record daily for a week at five time points through the trial: baseline, week 5, week 10, week 15, and week 20. Negative changes would suggest improvements in number, type, or severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Total and Subscores in Functional Assessment of Cancer Therapy- Breast Cancer | 10 weeks | Changes in scores were calculated as (Week-10 - baseline). Since a higher score on any FACT-B subscale indicates better quality of life, a positive change would suggest that the patient's score improved during that time interval. |
| Changes in the Endocrine Symptom Subscale (ESS) in Functional Assessment of Cancer Therapy- Endocrine Symptoms (FACT-ES) | 10 weeks | The ESS is one subscale of the FACT-ES that assesses hormonal symptoms of endocrine therapy. The score ranges from 0-76 with higher scores indicating greater freedom from symptoms. Changes in scores were calculated as (Week-10 - baseline). Since a higher score reflects increased freedom from hormonal symptoms, a positive change would suggest that the patient's symptoms improved during that time interval. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWeidong Lu, PhD, MPH
Dana-Farber Cancer Institute
Participant flow
Recruitment details
84 patients consented, and 78 patients were randomized.
Pre-assignment details
Enrollment: Accrual began in January-February 2019. DFCI site suspended study accrual for several months during the COVID-19 pandemic and resumed when approved by local authorities. DFCI completed accrual in June 2021, meeting its accrual goal. Due to the pandemic, 84 patients who consented to participate but 6 were not able to be randomized to the study therapy.
Participants by arm
| Arm | Count |
|---|---|
| Immediate Acupuncture * received a standardized acupuncture protocol for a 10-week period
* 20 sessions: twice a week for 10 weeks
* After the completion of the 10 weeks main study period, participants crossed over to the usual care as a follow-up without acupuncture for additional 10 weeks.
Acupuncture: Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are inserted into various spots on your skin, with the goal of affecting body's natural healing system | 39 |
| Delayed Acupuncture * received standard, usual care without acupuncture for 10 weeks
* Participants crossed over to receive the same acupuncture protocol for 10 weeks --10 sessions: once a week for 10 weeks before exiting the study
Usual Care: the current standard of care with non-hormonal pharmacotherapy of western medicine | 39 |
| Total | 78 |
Baseline characteristics
| Characteristic | Delayed Acupuncture | Total | Immediate Acupuncture |
|---|---|---|---|
| Age, Continuous | 47.7 Years STANDARD_DEVIATION 7.7 | 49 Years STANDARD_DEVIATION 9.45 | 50.3 Years STANDARD_DEVIATION 11.2 |
| ESS of FACT-ES | 51.6 units on a scale STANDARD_DEVIATION 8.5 | 50.8 units on a scale STANDARD_DEVIATION 8.65 | 50.0 units on a scale STANDARD_DEVIATION 8.8 |
| FACT-B Total Score | 103.6 FACT-B total score STANDARD_DEVIATION 16.3 | 103.05 FACT-B total score STANDARD_DEVIATION 17.1 | 102.5 FACT-B total score STANDARD_DEVIATION 17.9 |
| Hot Flash Score | 11.0 HFS units on a scale STANDARD_DEVIATION 7.2 | 10.25 HFS units on a scale STANDARD_DEVIATION 7 | 9.5 HFS units on a scale STANDARD_DEVIATION 6.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 63 Participants | 33 Participants |
| Region of Enrollment United States | 39 participants | 78 participants | 39 participants |
| Sex: Female, Male Female | 39 Participants | 78 Participants | 39 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 39 | 0 / 39 | 0 / 39 |
| other Total, other adverse events | 2 / 39 | 0 / 39 | 0 / 39 | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 | 0 / 39 | 0 / 39 |
Outcome results
Primary
Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10
Daily Hot Flash Diary (DHFD) The DHFD is a measure of self-reported hot flash data that uses a diary to record the frequency and severity of hot flashes based on a 4-point scale (i.e., mild, moderate, severe, or very severe) to provide a hot flash score/index that reflects both number and severity of hot flashes (i.e., sum of the number of hot flashes multiplied by a weighted severity). Patients were asked to record daily for a week at five time points through the trial: baseline, week 5, week 10, week 15, and week 20. Negative changes would suggest improvements in number, type, or severity.
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Acupuncture | Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10 | -5.3 HFS score on a scale | Standard Deviation 3.9 |
| Delayed Acupuncture | Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10 | -0.5 HFS score on a scale | Standard Deviation 6.5 |
p-value: 0.0003Mixed Models Analysis
Secondary
Changes in the Endocrine Symptom Subscale (ESS) in Functional Assessment of Cancer Therapy- Endocrine Symptoms (FACT-ES)
The ESS is one subscale of the FACT-ES that assesses hormonal symptoms of endocrine therapy. The score ranges from 0-76 with higher scores indicating greater freedom from symptoms. Changes in scores were calculated as (Week-10 - baseline). Since a higher score reflects increased freedom from hormonal symptoms, a positive change would suggest that the patient's symptoms improved during that time interval.
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Acupuncture | Changes in the Endocrine Symptom Subscale (ESS) in Functional Assessment of Cancer Therapy- Endocrine Symptoms (FACT-ES) | 5.3 ESS score on FACT-ES | Standard Deviation 7 |
| Delayed Acupuncture | Changes in the Endocrine Symptom Subscale (ESS) in Functional Assessment of Cancer Therapy- Endocrine Symptoms (FACT-ES) | -0.5 ESS score on FACT-ES | Standard Deviation 6.6 |
p-value: 0.002Mixed Models Analysis
Secondary
Changes in the Total and Subscores in Functional Assessment of Cancer Therapy- Breast Cancer
Changes in scores were calculated as (Week-10 - baseline). Since a higher score on any FACT-B subscale indicates better quality of life, a positive change would suggest that the patient's score improved during that time interval.
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Acupuncture | Changes in the Total and Subscores in Functional Assessment of Cancer Therapy- Breast Cancer | 6.6 FACT-B total score | Standard Deviation 11.3 |
| Delayed Acupuncture | Changes in the Total and Subscores in Functional Assessment of Cancer Therapy- Breast Cancer | -1.9 FACT-B total score | Standard Deviation 8.4 |