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Active Not Recruiting
NCT02221700
Massage Therapy in Reducing Chemotherapy-Induced Peripheral Neuropathy in Patients With Gastrointestinal or Breast Malignancies
Conditions: Malignant Breast Neoplasm, Malignant Digestive System Neoplasm, Peripheral Neuropathy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: M.D. Anderson Cancer Center
Location: M D Anderson Cancer Center Houston Texas
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.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT02221700). StuddyBuddy aggregates publicly available trial information.