Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Aromatase Inhibitors

This is a single arm study. All the enrolled patients will receive acupuncture twice weekly for 6 weeks then once weekly for another 6 weeks.

Patients with stiffness of joint receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.

Acupuncture

Dengfeng Ren

Jiuda Zhao

RATIONALE: Acupuncture may help relieve joint stiffness related to aromatase inhibitors in patients with early-stage breast cancer.

PURPOSE: This single arm clinical study aims to evaluate how well acupuncture as a non-pharmacological treatment, works in treating patients with joint stiffness related to aromatase inhibitors (AIs) in patients with early-stage breast cancer.

Objectives of this study:

Primary objective:

To evaluate whether acupuncture as a non-pharmacological treatment, administered twice weekly for 6 weeks can significantly reduce joint stiffness related to AIs in women with early-stage breast cancer as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) stiffness score at weeks 6.

Secondary objectives:

To evaluate the effect of acupuncture on joint stiffness measured by the WOMAC stiffness score at weeks 12.

To evaluate the effect of acupuncture on joint stiffness measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH) stiffness score at weeks 6 and weeks 12.

To evaluate the effects of acupuncture on quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES) at weeks 6 and weeks 12.

To evaluate the safety and tolerability of acupuncture in the enrolled patients.

To identify potential genetic determinants to response to acupuncture.

This study just enroll female patients with breast cancer.

Acupuncture for Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer

Efficacy and Safety of Acupuncture for Relieving Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer

The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) at the end of week 6 of intervention compared to that at baseline.

The change in stiffness score as measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH) at the end of week 6 of intervention compared to that at baseline.

Affiliated Hospital of Qinghai University

Professor

Blood and Lymph Conditions

Symptoms and General Pathology

Lymphedema

Breast Cancer Lymphedema

Lymphatic Diseases

Postoperative Complications

Both Extremities of Patients With Breast Cancer Related Lymphedema

Both Extremities of Healthy People With No History of Breast Cancer

We evaluated the both upper extremities of the patient and control group with elastography and B mode ultrasonography. Shear wave elastography evaluates tissue deformation caused by acoustic radiation force. A highly focused ultrasound radiation is produced; The propagation speed of the shear wave depends on the stiffness of the tissue. It is a simple, inexpensive, bedside, widely available, non-invasive technique. B mode USG can be used to assess skin and subcutaneous tissue thickness and echogenicity. Skin and subcutaneous thickness were measured with b mode ultrasound. Skin and subcutaneous tissue stiffness was measured by shear wave ultrasonography

Shear Wave Elastography and B Mode Ultrasonography

Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. In the questionnaire, the difficulties of the patients during their daily living activities are questioned with 11 questions. Each answer is scored from 1 to 5 on a Likert scale, from best to worst.

Quick Dash Questionnare

The Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 functional subgroups. Each question is scored from 1 to 5, with higher scores indicating increased seriousness.

The Lymphedema Life Impact Scale

Arm pain and feeling of tension, heaviness and stiffness in the arm were evaluated separately by numerical scale. This scale is a 10 cm ruler that writes no pain, no tension, no heaviness, no stiffness on one side, and unbearable pain, tension and heaviness on the other side. Patients were asked to rate their associated symptoms on this scale between 0 and 10.

Questioning lymphedema-related symptoms

For the diagnosis of lymphedema, a detailed physical examination and extremity circumference were measured. This measurement was taken from both wrists to arm height with 4 cm intervals. Those with a circumference difference greater than 2 cm and/or no 10% volume difference were considered preclinical (latent) and those with clinical lymphedema.

Extremity circumference and volume measurement

CANAN ŞANAL TOPRAK

The aim of this study is to evaluate the feasibility of shear-wave elastography for the diagnosis and staging of breast cancer related lymphedema by assessing the skin and subcutaneous tissues of the arm and forearm, which could serve as a reference standard and be more easily applicable in daily life; and to investigate the relationship between the patients' symptoms and elastographic measurements.

Both upper extremities of 72 patients with lymphedema and 72 healthy upper extremities were included in the study. The patients' demographic and clinical data were recorded. The thickness and echogenicity of the skin and subcutaneous tissues of all extremities were evaluated with B-mode ultrasonography, and the stiffness of the skin and subcutaneous tissues was evaluated with shear-wave elastography. The lymphedema arm and the healthy arm of the patients were compared both with each other and with the data of the control group. Interobserver and intraobserver reliability analysis was performed for ultrasonography and elastography measurements. The patients' pain, tension, weight, and stiffness symptoms associated with lymphedema were questioned using a numerical scale. The patients' functionality and participation in daily life activities were evaluated with the Quick DASH and Life Impact Index questionnaires. The relationship between these findings and elastographic and ultrasonographic parameters was analyzed.

Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema

Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema and Investigation of the Relationship of These Parameters With Clinical Data

Arm and forearm skin and subcutaneous tissue thicknesses in milimetres evaluated by B mode USG

Arm and forearm skin and subcutaneous tissue stiffness in kilopascal evaluated by Shear wave elastography

Arm and forearm skin and subcutaneous tissue SEG and SEFS grades evaluated in echogenicity grade system by B mode USG

It is the relationship between the parameters evaluated by USG ( thickness in milimetres echogenity according to grading system) and SWE (stiffness in kilopascal) and the pain, tension, heaviness and stiffness scoring in which symptoms in numeric scale.

It is the relationship between the parameters evaluated by USG (thickhickness in milimetres , echogenity according to grading system) and SWE (stiffness in kilopascal) and QUİCK DASH Questionnaire Score

It is the relationship between the parameters evaluated by USG (thickness in milimetres ,echogenity according to grading system) and SWE (stiffness in kilopascal) and The Life İmpact Questionnaire Scale

It is the volume measurement of both arms of the patients in cubic centimetre.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Acupuncture for Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer	NCT05098951	Breast Cancer Stiffness of Ha...	Acupuncture	18 Years - 75 Years	Affiliated Hospital of Qinghai University
Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema	NCT06009666	Lymphedema of U... Stiffness of Ha... Evaluations, Di...	Shear Wave Elas... Quick Dash Ques... The Lymphedema ... Questioning lym... Extremity circu...	18 Years - 75 Years	Marmara University

Spots Global Cancer Trial Database for stiffness of hand, not elsewhere classified