A study to assess the hair changes post induction chemotherapy in pediatric patients with acute lymphoblastic leukemia and to study the effects of scalp cooling on ameliorating these changes
Not Applicable
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
- Registration Number
- CTRI/2023/06/054343
- Lead Sponsor
- Dr Aditya Kumar Gupta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
IR(Intermediate) and HR(High risk) ALL and undergoing induction chemotherapy.
Exclusion Criteria
Child receiving any therapy (topical or oral) for the alopecia.
Child unwilling to undergo scalp cooling.
Child with SAM
Child with poor hair hygiene
Child with suspected autoimmune disease.
Relapsed children or who have got any previous chemotherapy (apart from steroids).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Clinical <br/ ><br>1.Visual inspection byCTCAE GARDING <br/ ><br>2.Trichoscopic pattern <br/ ><br>- Black dots <br/ ><br>- Broken hairs <br/ ><br>- Exclamation marks <br/ ><br>- Flame hairs <br/ ><br>- Pohl pinkus <br/ ><br>- Circle hair <br/ ><br>- pigtails <br/ ><br>3. Trichogram characteristic <br/ ><br>- Dystrophic anagen hairs <br/ ><br>- Dysplatic anagen hairs <br/ ><br>4.Radiological (Ultrasonography) <br/ ><br>S.USG Parameter <br/ ><br>- Dermal thickness <br/ ><br>- Scalp hair follicle depth <br/ ><br>- Scalp hair follicle transverse diameter(width) <br/ ><br>- Hair shaft thickness <br/ ><br>5. 4.Anatomical (ultrastructure- using SEM) <br/ ><br>Shaft <br/ ><br>Root of hair <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: pre and post induction chemotherapy in control arm
- Secondary Outcome Measures
Name Time Method 1.Clinical <br/ ><br>1.Visual inspection byCTCAE GARDING <br/ ><br>2.Trichoscopic pattern <br/ ><br>- Black dots <br/ ><br>- Broken hairs <br/ ><br>- Exclamation marks <br/ ><br>- Flame hairs <br/ ><br>- Pohl pinkus <br/ ><br>- Circle hair <br/ ><br>- pigtails <br/ ><br>3. Trichogram characteristic <br/ ><br>- Dystrophic anagen hairs <br/ ><br>- Dysplatic anagen hairs <br/ ><br>4.Radiological (Ultrasonography) <br/ ><br>S.USG Parameter <br/ ><br>- Dermal thickness <br/ ><br>- Scalp hair follicle depth <br/ ><br>- Scalp hair follicle transverse diameter(width) <br/ ><br>- Hair shaft thickness <br/ ><br>5. 4.Anatomical (ultrastructure- using SEM) <br/ ><br>Shaft <br/ ><br>Root of hair <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: pre and post induction chemotherapy in intervention and control arm