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Clinical Trials/CTRI/2021/01/030480
CTRI/2021/01/030480
Completed
Phase 3

Acupuncture as a modality of treatment for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer-A Phase 3 Randomized Controlled Trial (ABC-CIPN).

Tata Memorial Center0 sites104 target enrollmentTBD
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ConditionsHealth Condition 1: C509- Malignant neoplasm of breast of unspecified site

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Sponsor
Tata Memorial Center
Enrollment
104
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
April 30, 2024
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Tata Memorial Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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