Massage Therapy in Reducing Chemotherapy-Induced Peripheral Neuropathy in Patients With Gastrointestinal or Breast Malignancies

NCT02221700 | Active Not Recruiting

• 2 other identifiers: 2014-0250NCI-2015-00386
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Breast Neoplasm; Malignant Digestive System Neoplasm; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Completion Rates of Two Massage Treatment Protocols for Patients With Chronic, Oxaliplatin-Induced Peripheral Neuropathy

  Completion rate defined as the average number of treatments completed of a possible 12 for patients in each protocol. Mean and standard deviation, along with a 95% confidence interval (CI) of the mean of the number of massages completed for each of the two massage schedules computed. Two-sample t-test used to compare the number of massages completed between the two schedules using a two-sided 0.05 significance level.

  10 weeks

Secondary Outcomes (5)

• Quality and intensity of neuropathic pain

  At 10 weeks

• Quality of life (QOL)

  Up to 10 weeks

• Function and balance

  Up to 10 weeks

• Symptoms associated specifically with chemotherapy-induced peripheral neuropathy

  Up to 10 weeks

• Baseline treatment expectations

  Baseline

Study Arms (4)

Group I (leg massage 3 x weekly for 4 weeks)

EXPERIMENTAL

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.

Procedure: Massage Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group II (leg massage 2 x weekly for 6 weeks)

EXPERIMENTAL

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.

Procedure: Massage Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group III (head/neck/shoulder massage 3 x weekly for 4 weeks)

EXPERIMENTAL

Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder thrice weekly for 4 weeks.

Procedure: Massage Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)

EXPERIMENTAL

Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder twice weekly for 6 weeks.

Procedure: Massage Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (leg massage 3 x weekly for 4 weeks); Group II (leg massage 2 x weekly for 6 weeks); Group III (head/neck/shoulder massage 3 x weekly for 4 weeks); Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)

Massage Therapy PROCEDURE

Undergo massage therapy

Also known as: Massage

Group I (leg massage 3 x weekly for 4 weeks); Group II (leg massage 2 x weekly for 6 weeks); Group III (head/neck/shoulder massage 3 x weekly for 4 weeks); Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)

Questionnaire Administration OTHER

Ancillary studies

Group I (leg massage 3 x weekly for 4 weeks); Group II (leg massage 2 x weekly for 6 weeks); Group III (head/neck/shoulder massage 3 x weekly for 4 weeks); Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms; Gastrointestinal Neoplasms; Peripheral Nervous System Diseases

Interventions

Massage

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Gabriel Lopez

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 20, 2014
• Study Start: April 9, 2015
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)