None listed
Conditions
Interventions
Medical Device : Acupuncture treatment
1. Sterile disposable acupuncture needles (0.25 x 40mm)
2. Frequency: twice to three times a week during 4 weeks (a total of 8 to 12 acupuncture treatments)
3. S
Sponsors
Kyung Hee University Oriental Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients after breast cancer surgery and chemotherapy or radiotherapy at least 1 months before the participation 2. Women aged from 32 yrs to 64 yrs 3. Patients with at least 1 symptom below and severity of over 4 in 0 to 10 Numeric Rating Scale 3-1 Arthralgia after the treatment with Aromatase inhibitors 3-2 Hot flush or Sweating after the treatment with Anti-estrogen agents 3-3 Insomnia 3-4 Sexual dysfunction (Vaginal dryness or Dyspareunia) 3-5 Pain after mastectomy 4. Patients who visits hospital on an outpatient basis regularly for additional treatments and monitoring after breast cancer surgery and chemotherapy or radiotherapy 5. Patients who would agree with the participation of this study and sign written informed consent
Exclusion criteria
Exclusion criteria: 1. Those who have diseases or conditions below 1-1 Recurrence of tumor or having other primary cancer 1-2 Uncontrolled acute and chronic diseases 1-3 Uncontrolled current mental disorders including panic disorder, acute episode of mania, delusion, hallucination etc. 1-4 Having fear against acupuncture 1-5 Having above symptoms and diagnosed with specific diseases which introduce those symptoms before breast cancer surgery 2. Women who is pregnant, breast feeding or planning pregnancy 3. Anyone who does not have appropriate ability to answer questionnaires or has difficulty in visiting our clinical trial center 4. Anyone who is expected not to be appropriate to participate in this study judged by research personnel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Selection and enrollment of the participants, subject number per symptoms;Compliance on study design and acupuncture treatments;Adverse events related to acupuncture treatments;Feasibility based on the experience of participants | — |
Secondary
| Measure | Time frame |
|---|---|
| Common outcome variable 1- severity of the main symtom (0-10 Numeric Ratign Scale);Common outcome variable 2- the European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23);Common outcome variable 3- Measure Yourself Medical Outcome Profile;Common outcome variable 4- Functional Assessment of Chronic Illness Therapy-fatigue scale;Common outcome variable 5- Chage of concomitant drugs and treatments;Patients with arthralgia after aromatase inhibitors- Brief Pain Inventory- Short Form, The Western Ontario and McMaster Universities Arthritis Index and Analgesic medication ;Patients with vasomotor symptoms after usage of anti-estrogen drugs- Hot flush diary (severity, frequency), Menopausal Rating Scale;Patients with insomnia- Pittsburgh Sleep Quality Index, Women's Health Initiative Insomnia Rating Scale;Patients with sexual dysfunction (vaginal dryness, dyspareuria)- Female Sexual Functioning Index, Female Sexual Distress Scale, Arizona Sexual Experience Scale;Patients with pain after breast surgery- Brief Pain Inventory-Short Form, Pain frequency and duration, Shoulder ROM, Analgesic medication recorded in self-reported diary | — |
Countries
Korea, Republic of
Contacts
Public ContactTae-Hun Kim
Kyung Hee University Oriental Medical Center
Outcome results
None listed