To treat patients suffering from CIPN during chemo therapy using accupunture therapy

Phase 3

Completed

Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Registration Number: CTRI/2021/01/030480

Lead Sponsor: Tata Memorial Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 104

Inclusion Criteria

1 Patients with non metastatic breast cancer who have been experiencing grade 1 or greater CIPN for more than 1 week after completion of paclitaxel based chemotherapy

2 Aged 18 or above

3 ECOG performance status 0–1

4 Ability to fill the self-reported questionnaire in any of the three languages (English, Hindi or Marathi).

5 Normal blood counts defined as per WHO standards

Female: Hemoglobin: 12.0-15.5 grams/dL, TLC-4000-11000 and PLC-1.5 lakhs to4 lakhs.

Exclusion Criteria

1 ECOG performance status 2 or above

2 Patients who have hyperalgesia or allodynia

3 Patients having pre-existing causes of peripheral neuropathy like diabetic neuropathy, CKD

4 Patients with bleeding disorders

5 Unstable cardiac disease or myocardial infarction within 6 months prior to study entry

6 Peripheral neuropathy caused by tumor infiltration or compression of spinal nerves or surgical trauma

7 Pregnancy or potential pregnancy and nursing

8 Active clinically significant uncontrolled infection

9 Prior use of acupuncture for CIPN within 6 months prior to study entry

10 Patients with uncontrolled major psychiatric disorders, such as major depression or psychosis, will not be eligible for this trial. Patients with a history of depression or anxiety who are stable on or off psychiatric medications will be eligible

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Improvement in Quality of life <br/ ><br>To assess the quality of life of the patients at starting of therapy and at 8 weeks of therapy <br/ ><br>2 Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20) which has been validated in local languages and would be made available to the patients. <br/ ><br>3 The pain detect questionnaire <br/ ><br>4 EORTC Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). <br/ ><br>Timepoint: 8 weeks 12 weeks and 6 months from randomisation

Secondary Outcome Measures

Name	Time	Method
1 To assess the neuropathy symptoms at 12 weeks and 6 months to see the long lasting effects of acupuncture on peripheral neuropathy <br/ ><br>2 To calculate number of patients completing the allocated sittings of acupuncture <br/ ><br>Timepoint: 8 weeks 12 weeks and 6 months from randomization