Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112996
Status:
COMPLETED
Last Update Posted:
2014-04-08
First Post:
2005-06-02
Brief Title:
Alpha-Lipoic Acid in Preventing Peripheral Neuropathy in Patients Receiving Chemotherapy for Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Prevention of Cisplatin- or Oxaliplatin-Induced Peripheral Neuropathy With Alpha-Lipoic Acid A Placebo-Controlled Phase III Trial
Status:
COMPLETED
Status Verified Date:
2014-04
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:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Chemoprotective drugs such as alpha-lipoic acid may protect normal cells from the side effects of chemotherapy Alpha-lipoic acid may also prevent damage to nerves that carry information to and from the brain and spinal cord to the rest of the body It is not known whether alpha-lipoic acid is more effective than placebo in preventing peripheral neuropathy
PURPOSE This randomized phase III trial is studying alpha-lipoic acid to see how well it works compared to placebo in preventing peripheral neuropathy in patients receiving chemotherapy for cancer
PURPOSE This randomized phase III trial is studying alpha-lipoic acid to see how well it works compared to placebo in preventing peripheral neuropathy in patients receiving chemotherapy for cancer
Detailed Description:
OBJECTIVES
Primary
Compare whether treatment with alpha-lipoic acid vs placebo decreases the severity and frequency of peripheral neuropathy in cancer patients receiving a cisplatin- or oxaliplatin-containing chemotherapy regimen
Compare the protective effect duration of these drugs in these patients
Secondary
Determine large sensory fiber integrity associated with platinum-induced peripheral neuropathy as measured by three timed functional tests comprising fastening 6-buttons walking 50 feet and placing coins in a cup in patients treated with these drugs
Compare the number of chemotherapy courses and doses received by patients treated with these drugs
Tertiary
Compare the optimal tumor response disease progression stable disease partial response or complete response to chemotherapy in patients treated with these drugs
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to prior platinum-containing treatment yes vs no Patients who received prior treatment are further stratified according to prior cumulative platinum exposure cisplatin 200 mgm2 or oxaliplatin 750 mgm2 vs cisplatin 200-399 mgm2 or oxaliplatin 750-999 mgm2 vs cisplatin 400 mgm2 or oxaliplatin 1000 mgm2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral alpha-lipoic acid three times daily for at least 24 weeks in the absence of unacceptable toxicity
Arm II Patients receive oral placebo three times daily for at least 24 weeks in the absence of unacceptable toxicity
NOTE In both arms patients begin taking study drug 4 days after completion of each chemotherapy treatment and continue taking study drug until 2 days before their next scheduled chemotherapy treatment
Patients symptoms of peripheral neuropathy pain and functional tests are assessed at baseline and then at weeks 6-8 12 24 36 and 48
PROJECTED ACCRUAL A total of 244 patients 122 per treatment arm will be accrued for this study within 2 years
Primary
Compare whether treatment with alpha-lipoic acid vs placebo decreases the severity and frequency of peripheral neuropathy in cancer patients receiving a cisplatin- or oxaliplatin-containing chemotherapy regimen
Compare the protective effect duration of these drugs in these patients
Secondary
Determine large sensory fiber integrity associated with platinum-induced peripheral neuropathy as measured by three timed functional tests comprising fastening 6-buttons walking 50 feet and placing coins in a cup in patients treated with these drugs
Compare the number of chemotherapy courses and doses received by patients treated with these drugs
Tertiary
Compare the optimal tumor response disease progression stable disease partial response or complete response to chemotherapy in patients treated with these drugs
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to prior platinum-containing treatment yes vs no Patients who received prior treatment are further stratified according to prior cumulative platinum exposure cisplatin 200 mgm2 or oxaliplatin 750 mgm2 vs cisplatin 200-399 mgm2 or oxaliplatin 750-999 mgm2 vs cisplatin 400 mgm2 or oxaliplatin 1000 mgm2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral alpha-lipoic acid three times daily for at least 24 weeks in the absence of unacceptable toxicity
Arm II Patients receive oral placebo three times daily for at least 24 weeks in the absence of unacceptable toxicity
NOTE In both arms patients begin taking study drug 4 days after completion of each chemotherapy treatment and continue taking study drug until 2 days before their next scheduled chemotherapy treatment
Patients symptoms of peripheral neuropathy pain and functional tests are assessed at baseline and then at weeks 6-8 12 24 36 and 48
PROJECTED ACCRUAL A total of 244 patients 122 per treatment arm will be accrued for this study within 2 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MDA-CCC-0327 | None | None | None |
| MDA-2004-0728 | None | None | None |
| 2004-0728 | OTHER | None | None |
| NCI-2009-00636 | REGISTRY | None | None |
| 3U10CA045809-15S1 | NIH | NCI CTRP | httpsreporternihgovquickSearch3U10CA045809-15S1 |