Clinical trial NCT02221700: Massage Therapy in Reducing Chemotherapy-Induced Peripheral Neuropathy in Patients With Gastrointestinal or Breast Malignancies
Official title: A Pilot Study of Massage for Symptom Reduction in Chemotherapy-Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malignant Breast Neoplasm
Malignant Digestive System Neoplasm
Peripheral Neuropathy
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-08-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 (head/neck/shoulder) 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.

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

Primary outcomes:
measure: Completion Rates of Two Massage Treatment Protocols for Patients With Chronic, Oxaliplatin-Induced Peripheral Neuropathy
timeFrame: 10 weeks
Secondary outcomes:
measure: Quality and intensity of neuropathic pain
timeFrame: At 10 weeks
measure: Quality of life (QOL)
timeFrame: Up to 10 weeks
measure: Function and balance
timeFrame: Up to 10 weeks
measure: Symptoms associated specifically with chemotherapy-induced peripheral neuropathy
timeFrame: Up to 10 weeks
measure: Baseline treatment expectations
timeFrame: Baseline
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Gabriel Lopez
role: PRINCIPAL_INVESTIGATOR
References: