| CTRI Number |
CTRI/2024/02/062953 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Nail changes in breast cancer patients receiving paclitaxel chemotherapy |
|
Scientific Title of Study
|
Exploring paclitaxel inducednail changes in patients receiving weekly paclitaxel - A Clinical observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ananth Pai |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
No:02, 1st floor Department of Medical Oncology, Shridi Saibaba cancer hospital, Kasturba Medical College and Hospital, Manipal, Udupi dist
Udupi
KARNATAKA
576104
India |
| Phone |
9880239139 |
| Fax |
|
| Email |
ananth.pai@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ananth Pai |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
No:02, 1st floor Department of Medical Oncology, Shridi Saibaba cancer hospital, Kasturba Medical College and Hospital, Manipal, Udupi dist
KARNATAKA
576104
India |
| Phone |
9880239139 |
| Fax |
|
| Email |
ananth.pai@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ananth Pai |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
No:02, 1st floor Department of Medical Oncology, Shridi Saibaba cancer hospital, Kasturba Medical College and Hospital, Manipal, Udupi dist
KARNATAKA
576104
India |
| Phone |
9880239139 |
| Fax |
|
| Email |
ananth.pai@manipal.edu |
|
|
Source of Monetary or Material Support
|
| No:02, 1st floor Department of Medical Oncology, Shridi Saibaba cancer hospital, Kasturba Medical College and Hospital, Manipal, Udupi district |
|
|
Primary Sponsor
|
| Name |
Dr. Ananth Pai |
| Address |
No:02, 1st floor Department of Medical Oncology, Shridi Saibaba cancer hospital, Kasturba Medical College and Hospital, Manipal, Udupi district |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ananth Pai |
Kasturba Medical College and Hospital , Manipal |
Room No 2 1st floor Department of Medical Oncology Unit 1 and 2, Shridi Saibaba cancer hospital, Kasturba Medical College and Hospital, Manipal, Udupi district
Udupi
KARNATAKA
Udupi
KARNATAKA |
9880239139
-
ananth.pai@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age ≥ 18 years.
Female patients
Diagnosed with histologically verified, all malignancy breast and ovarian cancers for the first time.
Planned for AC-Taxol protocol on weekly (Adriamycin and cyclophosphamide, followed by treatment with paclitaxel)
|
|
| ExclusionCriteria |
| Details |
Any patients with previous dermatological or systematic disorders which affect nails.
Serious nail changes that need interventional management such as acute paronychia and Onycholysis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Demographic characteristics, clinical presentations, histopathology reports, diagnostic results, and treatment details.
2.Evaluate the nails by using National Cancer Institute criteria (Common Terminology Criteria for Adverse Events, Version 4.0) by clinical examination. |
0 weeks - baseline, 9th week and last chemotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="184"
Sample Size from India="184"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Newly diagnosed breast cancer patients and who will be assigned for paclitaxel based chemotherapy as a normal care will be approached for the participation in this study. Chemotherapeutic drugs induced nail alterations. However, during the
course of treatment, nail changes can
transform from tolerable morphological and structural changes into painful
lesions that can impair several
functionalities. The mechanism by which chemotherapeutic agents affect nails is not well understood or
well-studied. In this study, we represent a clinical observation on the nail
changes in patients receiving weekly paclitaxel.
|