Ignite Creation Date:
2024-05-06 @ 12:22 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01557608
Status:
COMPLETED
Last Update Posted:
2020-01-14
First Post:
2012-02-28
Brief Title:
Characterization and Treatment of Chemotherapy Neuropathy
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Characterization of and Treatment for Chemotherapy-Induced Neuropathy
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIN
Brief Summary:
Numbness tingling and pain in the hands and feet following the administration of chemotherapy also called chemotherapy-induced neuropathy CIN is a common problem in oncology patients However more information is needed on why patients develop neuropathy and how it impacts their mood ability to function and their quality of life In addition effective treatments for this problem are not available at the present time This study will be conducted in two parts In Part 1 patients who have finished chemotherapy and did or did not develop CIN will be evaluated to determine why some patients do and other patients do not develop CIN In addition the impact of CIN on patients mood function and quality of life will be evaluated by comparing patients reports on these important outcome measures In addition genetic markers that contribute to or protect against the development of CIN will be evaluated Part 2 of this study will test the effects of a new treatment called photon stimulation also called infrared light therapy compared to placebo treatment to improve sensations in the feet of oncology patients with CIN Patients who receive the photon stimulation will have greater improvement in sensation in their feet compared with those who do not receive photon stimulation
Detailed Description:
This protocol is designed in two parts Part 1 will use an extreme phenotype approach to evaluate the phenotypic and genotypic characteristics of chemotherapy induced neuropathyCINin a sample of oncology patients who have completed their chemotherapy and didn400and did not n200 develop CIN Patients with and without CIN will be matched in a 2 to 1 ratio on their cancer diagnosis and CTX agents administered ie only a platinum compound only a taxane or both Patients will be recruited in cohorts of 30 to 40 to insure that the matching criteria are met and the 21 ratio is achieved
In a single study visit to take place at the outpatient CTSI CRC CCRC at Mt Zionparticipants will be enrolled complete a battery of sensorimotor tests and questionnaires and provide a single blood specimen for genomic analysis
Part 2 will be a pilot study of a randomized double-blind placebo-controlled clinical trial RDBPCT of photon stimulation in a sample of patients n142 with CIN who participated in Part 1 Participants will be randomized to receive the active treatment or the placebo in a series of 8 treatments lasting 7 minutes each across a 14-day period Participants will be assessed at baseline and after the 2nd 4th 6th and 8th treatments with sensory motor balance pain intensity and pain quality measures mood and quality of life measures Blood specimens will be drawn on treatment days 1 4 5 and 8 for gene expression
101 Study design 102 Check
In a single study visit to take place at the outpatient CTSI CRC CCRC at Mt Zionparticipants will be enrolled complete a battery of sensorimotor tests and questionnaires and provide a single blood specimen for genomic analysis
Part 2 will be a pilot study of a randomized double-blind placebo-controlled clinical trial RDBPCT of photon stimulation in a sample of patients n142 with CIN who participated in Part 1 Participants will be randomized to receive the active treatment or the placebo in a series of 8 treatments lasting 7 minutes each across a 14-day period Participants will be assessed at baseline and after the 2nd 4th 6th and 8th treatments with sensory motor balance pain intensity and pain quality measures mood and quality of life measures Blood specimens will be drawn on treatment days 1 4 5 and 8 for gene expression
101 Study design 102 Check
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None