Acupuncture Treatment of Vasomotor Symptoms in Breast Cancer Patients (Acu-HOTFLASH)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Hot flashes, Acupuncture
Eligibility Criteria
Inclusion Criteria: Premenopausal Breast Cancer patients Stage I-III breast cancer patients undergoing LHRHa plus ET (tamoxifen or aromatase inhibitors) after surgery Informed consent Exclusion Criteria: Ongoing LHRHa during chemotherapy Ongoing pharmacological therapy or natural products consumption for vasomotor symptoms Metastatic breast cancer Ongoing heparin or anticoagulant therapy Psychiatric conditions
Sites / Locations
- Fondazione Policlinico Gemelli- IRCCSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acupuncture arm
Usual care arm
Arm Description
Intervention with 10 acupuncture sessions twice per week for 4 weeks followed by 2 more sessions once per week
Lifestyle recommendations
Outcomes
Primary Outcome Measures
Reduction of frequency and intensity of hot flashes following acupuncture treatment
Hot flashes will be measured by the Hot Flash Composite Score (HFCS)
Secondary Outcome Measures
Sleep quality
Sleep quality will be measured by Pittsburgh Sleep Quality Index (PSQI)
Quality of life (QoL)
QoL will be measured by Menopause-specific Quality of Life Questionnaire (MenQOL) and EORTC Quality of Life Questionnaire (EORTC QLQ-C30).
Full Information
NCT ID
NCT05760222
First Posted
February 27, 2023
Last Updated
February 27, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT05760222
Brief Title
Acupuncture Treatment of Vasomotor Symptoms in Breast Cancer Patients
Acronym
Acu-HOTFLASH
Official Title
Early Acupuncture Treatment of Vasomotor Symptoms and Sleep Disorders in Breast Cancer Luteinising Hormone-releasing Hormone Analogues(LHRHa) Induced Menopause: AcuHOTFLASH Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2021 (Actual)
Primary Completion Date
May 25, 2024 (Anticipated)
Study Completion Date
December 25, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The goal of this clinical trial is to evaluate the impact of acupuncture in preventing worsening of hot flashes and sleep disorders in paucisymptomatic premenopausal Breast Cancer (BC) patients undergoing LHRHa plus endocrine therapy.
According to the published data, acupuncture is an effective and long-lasting (6 to 8 months) treatment for severe vasomotor symptoms. Treatment response can be affected by different variables, including intervention timing.
The main question this study aims to answer is:
Can we expect an additional benefit resulting from an early intervention (when patients are still presymptomatic/paucysintomatic) with acupuncture in preventing worsening in terms of frequency/severity of hot flashes and sleep disorders?
Researchers will compare patients randomized in two arms:
Arm A: intervention with acupuncture Arm B: usual care to see if acupuncture is superior to usual care in preventing worsening of hot flashes
Detailed Description
This is a prospective randomized clinical trial of superiority of acupuncture compared to usual care for prevention/early treatment of vasomotor symptoms and sleep impairment in LHRHa induced amenorrhea.
The primary endpoint will be a reduction in frequency and intensity of hot flashes in the intervention arm compared to standard care, measured by the Hot Flash Composite Score (HFCS) at 6 months following the protocol. Among the secondary outcomes, sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI) and quality of life by the Menopause-specific Quality of Life Questionnaire (MenQOL) and EORTC Quality of Life Questionnaire (EORTC-C30).
A total of 90 premenopausal BC (stage I-III) patients undergoing LHRHa plus Endocrine Therapy (tamoxifen or aromatase inhibitors) after surgery will be randomized 1:1 in two arms:
Arm A: intervention with 10 acupuncture sessions twice per week for 4 weeks followed by 2 more sessions once per week Arm B: usual care
Participants in both arms will report the hot flash frequency and severity daily (HFCS), and will fill three questionnaires (EORTC QLQ-C30, MenQoL, PSQI) according to the following timeline:
T0 (baseline): 6 weeks following the first LHRHa administration T1: 6 weeks from T0 (corresponding to the end of acupuncture protocol for Arm A) T2: 18 weeks from T0 T3: 30 weeks from T0
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Hot flashes, Acupuncture
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture arm
Arm Type
Experimental
Arm Description
Intervention with 10 acupuncture sessions twice per week for 4 weeks followed by 2 more sessions once per week
Arm Title
Usual care arm
Arm Type
No Intervention
Arm Description
Lifestyle recommendations
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture for prevention/early treatment of vasomotor symptoms and sleep impairment in LHRHa induced amenorrhea in Breast Cancer patients
Primary Outcome Measure Information:
Title
Reduction of frequency and intensity of hot flashes following acupuncture treatment
Description
Hot flashes will be measured by the Hot Flash Composite Score (HFCS)
Time Frame
HFCS collected for one week, 6 months following the protocol.
Secondary Outcome Measure Information:
Title
Sleep quality
Description
Sleep quality will be measured by Pittsburgh Sleep Quality Index (PSQI)
Time Frame
PSQI collected 6 months following the protocol.
Title
Quality of life (QoL)
Description
QoL will be measured by Menopause-specific Quality of Life Questionnaire (MenQOL) and EORTC Quality of Life Questionnaire (EORTC QLQ-C30).
Time Frame
MenQOL and EORTC QLQ-C30 will be collected 6 months following the protocol.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premenopausal Breast Cancer patients
Stage I-III breast cancer patients undergoing LHRHa plus ET (tamoxifen or aromatase inhibitors) after surgery
Informed consent
Exclusion Criteria:
Ongoing LHRHa during chemotherapy
Ongoing pharmacological therapy or natural products consumption for vasomotor symptoms
Metastatic breast cancer
Ongoing heparin or anticoagulant therapy
Psychiatric conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Magno
Phone
347 8551052
Email
stefano.magno@policlinicogemelli.it
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Maggiore
Phone
3498175958
Email
claudia.maggiore@guest.policlinicogemelli.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Magno
Organizational Affiliation
Fondazione policlinico Gemelli - IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Policlinico Gemelli- IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26304905
Citation
Mao JJ, Bowman MA, Xie SX, Bruner D, DeMichele A, Farrar JT. Electroacupuncture Versus Gabapentin for Hot Flashes Among Breast Cancer Survivors: A Randomized Placebo-Controlled Trial. J Clin Oncol. 2015 Nov 1;33(31):3615-20. doi: 10.1200/JCO.2015.60.9412. Epub 2015 Aug 24.
Results Reference
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PubMed Identifier
27022113
Citation
Lesi G, Razzini G, Musti MA, Stivanello E, Petrucci C, Benedetti B, Rondini E, Ligabue MB, Scaltriti L, Botti A, Artioli F, Mancuso P, Cardini F, Pandolfi P. Acupuncture As an Integrative Approach for the Treatment of Hot Flashes in Women With Breast Cancer: A Prospective Multicenter Randomized Controlled Trial (AcCliMaT). J Clin Oncol. 2016 May 20;34(15):1795-802. doi: 10.1200/JCO.2015.63.2893. Epub 2016 Mar 28.
Results Reference
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Learn more about this trial
Acupuncture Treatment of Vasomotor Symptoms in Breast Cancer Patients
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