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
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
PGIMER