Clinical trial NCT00871429: Skin Care for Cancer Patients: A Product Satisfaction Survey
Official title: Selected Skin Products for Cancer Patients: A Product Satisfaction Survey
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Toxicity
Keywords: skin toxicity
cancer patients
adverse effects
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-03-30
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is being done because the investigators would like to evaluate product satisfaction of three test products (product A, product B, product C) that are available at any drug store. This will be done by measuring any changes in the subjects' answers to the Skindex-16 questionnaire at two time points (at screening and baseline visit and at follow-up visit) and by evaluating their responses to the product satisfaction survey that will be given to them by a study coordinator.

Detailed description: The primary objective of this study is to evaluate product satisfaction of the following test articles A, B, and C: Lindi Skin soothing balm (product A), Lindi Skin face serum (product B), and Lindi Skin face wash (product C). This will be done by measuring change in Skindex-16 questionnaire at two time points (baseline and follow-up visits) and by evaluating responses to the investigator administered product satisfaction survey.

The secondary objective of this study is to see if there is any correlation between product satisfaction and grade of skin toxicity based on NCI-CTCAE v.3.0 scale.

Participants in this study will be patients seen at the Northwestern University SERIES clinic or Lurie Cancer Center who are receiving chemotherapeutic and or radiation treatments. Subjects who choose to participate complete a Skindex16 questionnaire, and will after consenting to participate, be given all three test articles A, B, and C to use daily for one month. (These test articles are currently marketed products classified by the FDA as cosmetics).

At the return visit, 1 month after baseline visit, the participant will be asked to return the test articles and complete an investigator administered product satisfaction questionnaire for each test article used. 100 participants will be surveyed. Subjects will be telephoned to check for product compliance after 1 week and 2 week intervals.

Eligibility criteria: Inclusion Criteria:

* Subjects who are at least 18 years of age.
* Subjects who have the willingness and ability to understand and provide informed consent to participate in the study and are able to communicate with the investigator.
* Subjects who are seen in the SERIES clinic or Lurie Cancer Center and who are receiving chemotherapy and/or radiation treatment for malignancy
* Subjects who have grade \<2 skin toxicity based on NCI-CTCAE v3.0 scale.
* Subjects who are routine cosmetics users

Exclusion Criteria:

* Under 18 years of age.
* Known allergy to any of the ingredients in the assigned products (Appendix C).
* Subjects who have grade 2,3,4 skin toxicity based on NCI-CTCAE v3.0 scale.
* Subjects who are pregnant, breast feeding, or those who are planning on becoming pregnant during test period.
* Subjects who use multiple topical agents on study areas

Primary outcomes:
measure: Product Satisfaction of the Following Test Articles A, B, and C: Lindi Skin Soothing Balm (Product A), Lindi Skin Face Serum (Product B), and Lindi Skin Face Wash (Product C)
timeFrame: one month of use
Secondary outcomes:
measure: Percentage of Subjects With Skin Toxicity Grades 0 to 5 Using The NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 at Baseline Visit and 1 Month Follow-up After Using Lindi Products.
timeFrame: one month
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Mario E Lacouture, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haley AC, Calahan C, Gandhi M, West DP, Rademaker A, Lacouture ME. Skin care management in cancer patients: an evaluation of quality of life and tolerability. Support Care Cancer. 2011 Apr;19(4):545-54. doi: 10.1007/s00520-010-0851-8. Epub 2010 Mar 25.