| CTRI Number |
CTRI/2013/10/004101 [Registered on: 25/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
19/02/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
skin side effects of anticancer drugs in cancer patients |
|
Scientific Title of Study
|
Cutaneous adverse effects of chemotherapy in cancer patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rachel Pavey |
| Designation |
Postgraduate student |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Dermatology,
Father Muller Medical College,Father Muller road,kankanady,Mangalore
Department of Dermatology,
Father Muller Medical College,Father Muller road,kankanady,Mangalore-575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9844810741 |
| Fax |
|
| Email |
rachelpavey11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinath M K |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Dermatology,
Father Muller Medical College,Father Muller road,kankanady,Mangalore
Department of Dermatology,
Father Muller Medical College,Father Muller road,kankanady,Mangalore-575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9886395249 |
| Fax |
|
| Email |
srinath76@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rachel Pavey |
| Designation |
Postgraduate student |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Dermatology,
Father Muller Medical College,Father Muller road,kankanady,Mangalore
Department of Dermatology,
Father Muller Medical College,Father Muller road,kankanady,Mangalore-575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9844810741 |
| Fax |
|
| Email |
rachelpavey11@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rachel Pavey |
| Address |
Department of dermatology,Father Muller Medical college,father muller road,Kankanady,Mangalore-575002 |
| 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 Rachel Pavey |
Father Muller Medical College |
Father Muller Medical College,father muller road,Kankanady,Mangalore-575002
Dakshina Kannada
KARNATAKA |
9844810741
rachelpavey11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
cutaneous adverse effects of chemotherapy in cancer patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)patients who give informed consent
2)patients of both sexes & age- 6 yrs & above
3)Patients willing to undergo necessary investigations if required
|
|
| ExclusionCriteria |
| Details |
1) Patients not willing for the study.
2)Patients having a primary skin disease.
3)Patients developing cutaneous manifestations as a result of internal malignancies & not on chemotherapy.
4)Patients on radiotherapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To describe the cutaneous adverse effects of chemotherapy & also its
frequency severity & distribution in cancer patients
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To describe the cutaneous adverse effects of chemotherapy & also its
frequency severity & distribution in cancer patients
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective,observational study in which 90 cancer patients on chemotherapy presenting with cutaneous adverse effects like alopecia,hyperpigmentation of skin,melanonychia,acne form eruptions,erythema nodosum,etc will be observed & studied.If required a skin biopsy would be done.No drug will be administered in this study |