Ignite Creation Date:
2024-05-06 @ 3:11 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02221700
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2014-08-19
Brief Title:
Massage Therapy in Reducing Chemotherapy-Induced Peripheral Neuropathy in Patients with Gastrointestinal or Breast Malignancies
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Pilot Study of Massage for Symptom Reduction in Chemotherapy-Induced Peripheral Neuropathy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
This clinical trial studies massage therapy in reducing chemotherapy-induced nerve problems peripheral neuropathy that may cause pain numbness tingling swelling or muscle weakness in different parts of the body in patients with gastrointestinal or breast malignancies Massage therapy may help reduce chemotherapy-induced peripheral neuropathy symptoms and improve quality of life
Detailed Description:
PRIMARY OBJECTIVES I To compare completion rates of two massage treatment protocols twice-weekly for 6 weeks versus three times weekly for 4 weeks for patients with chronic chemotherapy-induced peripheral neuropathy
SECONDARY OBJECTIVES
I To determine the initial efficacy and effect size estimates of twice versus three times weekly site specific lower extremity massage versus alternate massage site headneckshoulder control groups at treating chronic lower extremity chemotherapy-induced peripheral neuropathy
II To determine the initial efficacy and effect size estimates of massage on patient quality of life and functional performance tests
OUTLINE Patients are randomized to 1 of 4 groups
GROUP I Patients undergo massage therapy over 30 minutes to the affected legs at the foot and toes ending at the knee thrice weekly for 4 weeks
GROUP II Patients undergo massage therapy over 30 minutes to the affected legs at the foot and toes ending at the knee twice weekly for 6 weeks
GROUP III Patients undergo massage therapy over 30 minutes to the head neck and shoulder thrice weekly for 4 weeks
GROUP IV Patients undergo massage therapy over 30 minutes to the head neck and shoulder twice weekly for 6 weeks
After completion of study patients are followed periodically
SECONDARY OBJECTIVES
I To determine the initial efficacy and effect size estimates of twice versus three times weekly site specific lower extremity massage versus alternate massage site headneckshoulder control groups at treating chronic lower extremity chemotherapy-induced peripheral neuropathy
II To determine the initial efficacy and effect size estimates of massage on patient quality of life and functional performance tests
OUTLINE Patients are randomized to 1 of 4 groups
GROUP I Patients undergo massage therapy over 30 minutes to the affected legs at the foot and toes ending at the knee thrice weekly for 4 weeks
GROUP II Patients undergo massage therapy over 30 minutes to the affected legs at the foot and toes ending at the knee twice weekly for 6 weeks
GROUP III Patients undergo massage therapy over 30 minutes to the head neck and shoulder thrice weekly for 4 weeks
GROUP IV Patients undergo massage therapy over 30 minutes to the head neck and shoulder twice weekly for 6 weeks
After completion of study patients are followed periodically
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 |
|---|---|---|---|
| NCI-2015-00386 | REGISTRY | None | None |
| 2014-0250 | OTHER | M D Anderson Cancer Center | None |