Status:
ACTIVE_NOT_RECRUITING
Massage Therapy in Reducing Chemotherapy-Induced Peripheral Neuropathy in Patients With Gastrointestinal or Breast Malignancies
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Malignant Breast Neoplasm
Malignant Digestive System Neoplasm
Eligibility:
All Genders
18+ years
Phase:
NA
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 p...
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 p...
Eligibility Criteria
Inclusion
- All gastrointestinal malignancies where the patient received oxaliplatin for cancer treatment or breast malignancies where patients have received docetaxel or paclitaxel for cancer treatment
- Greater or equal to 6 months from last chemotherapy treatment
- Must understand and read English, sign a written informed consent, and follow protocol requirements
- Must be willing to come to MD Anderson Main Campus (Texas Medical Center) for intervention
- Lower extremity neuropathy per patient report attributable to oxaliplatin, docetaxel or paclitaxel (neurotoxic chemotherapeutic agent) as determined by patient history of neurotoxic agent administration and no history of other attributable causes such as diabetic neuropathy
- Patient self-report neuropathy score greater than or equal to 3 on a 0 to 10 numeric scale and/or grade 2 or 3 neuropathy (according to the National Cancer Institute Common Toxicity Criteria 4 point grading scale)
- Within 2 weeks prior to study enrollment the patient must be on a stable dose of medications for management of chemotherapy-induced peripheral neuropathy (CIPN) symptoms; for at least 2 weeks prior to enrollment stable dose is defined as:
- No change in drug class
- Increases or decreases that are less than or equal to 20% of the total dosage; all drug classes are allowed
Exclusion
- Patients with previously diagnosed peripheral neuropathy pre-dating their neurotoxic chemotherapy administration or from causes other than chemotherapy
- Platelets less than 50,000 within 6 months prior to study enrollment or
- Neutrophil count less than 500 within 6 months prior to study enrollment
- Deep venous thrombosis (DVT) diagnosed within 12 months of study enrollment or history or untreated lower extremity DVT, bone metastases, currently active skin infection, or lymphedema currently involving the treatment field
- Women who are pregnant at time of enrollment; pregnancy will be assessed at enrollment using urine pregnancy test
- Diagnosis of diabetes
Key Trial Info
Start Date :
April 9 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT02221700
Start Date
April 9 2015
End Date
April 30 2027
Last Update
October 2 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030