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Use of cryotherapy for prevention of Taxane-induced peripheral neuropathy

Assessment of effectiveness of limb cooling in prevention of Taxane-induced peripheral neuropathy - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096731
Enrollment
75
Registered
2025-10-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C34- Malignant neoplasm of bronchus andlung Health Condition 3: C15-C26- Malignant neoplasms of digestive organs Health Condition 4: C51-C58- Malignant neoplasms of female genital organs Health Condition 5: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Cryotherapy: Cryotherapy with frozen gloves and socks put on dominant side 15min before, during and upto 15 min after the infusion of the study chemotherapy agents Nab-Paclitaxel qwkly

Sponsors

Gaurav Prakash
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than and equal to 18yrs and less than 70yrs 2. ECOG PS less than equal to 2 3. Cancer patients planned for Taxane based chemotherapy. 4. A signed declaration of consent.

Exclusion criteria

Exclusion criteria: 1. Prior chemotherapy exposure 2. History or clinical exam suggestive of Raynaud’s phenomenon, cold intolerance, frost bite, peripheral vascular disease. 3. Prior known neuropathy of any etiology (including but not limited to alcohol, diabetic, nutritional, connective tissue disease, porphyria, critical illness, infectious, vasculitic, compression. 4. Organ dysfunction (renal/cardiac/liver) precluding use of chemotherapy drugs under study.

Design outcomes

Primary

MeasureTime frame
To study difference in development of moderate to severe TIPN of CTCAE gd greater than and equal to 2 in the control and intervention armsTimepoint: At start (baseline) and 12 weeks after initiation of study chemotherapy agents

Secondary

MeasureTime frame
To assess change in EORTC QLQ-CIPN20 scores in control and study arm.Timepoint: At baseline and at end of 12 weeks;To assess need for omission or dose reduction in the chemotherapy protocolTimepoint: At start of each chemotherapy cycle;To compare nerve conduction study parameters in study and control armTimepoint: At baseline and 12 weeks after the start of the study chemotherapy agents

Countries

India

Contacts

Public ContactGaurav Prakash

PGIMER

drgp04@gmail.com9914209678

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026