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

Not Applicable

Active, not recruiting

• Conditions: Malignant Digestive System Neoplasm; Peripheral Neuropathy; Malignant Breast Neoplasm
• Interventions: Procedure: Massage Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT02221700
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-20
• Study Start: 2015-04-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (leg massage 2 x weekly for 6 weeks)	Questionnaire Administration	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 I (leg massage 3 x weekly for 4 weeks)	Quality-of-Life Assessment	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 (leg massage 2 x weekly for 6 weeks)	Massage Therapy	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 I (leg massage 3 x weekly for 4 weeks)	Questionnaire Administration	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 (leg massage 2 x weekly for 6 weeks)	Quality-of-Life Assessment	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 (head/neck/shoulder massage 3 x weekly for 4 weeks)	Quality-of-Life Assessment	Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder thrice weekly for 4 weeks.
Group I (leg massage 3 x weekly for 4 weeks)	Massage Therapy	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 IV (head/neck/shoulder massage 2 x weekly for 6 weeks)	Quality-of-Life Assessment	Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder twice weekly for 6 weeks.
Group III (head/neck/shoulder massage 3 x weekly for 4 weeks)	Questionnaire Administration	Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder thrice weekly for 4 weeks.
Group III (head/neck/shoulder massage 3 x weekly for 4 weeks)	Massage Therapy	Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder thrice weekly for 4 weeks.
Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)	Massage Therapy	Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder twice weekly for 6 weeks.
Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)	Questionnaire Administration	Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder twice weekly for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Completion Rates of Two Massage Treatment Protocols for Patients With Chronic, Oxaliplatin-Induced Peripheral Neuropathy	10 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life (QOL)	Up to 10 weeks	Will be measured by the Medical Outcomes Study Short Form 36. Pairwise comparisons between arms will be made as desirable, adjusting for multiple comparisons using the Bonferroni approach. Similar linear regression and LMM analyses will be carried out for the QOL and function measures.
Symptoms associated specifically with chemotherapy-induced peripheral neuropathy	Up to 10 weeks	Will be assessed using the Functional Assessment of Cancer Therapy/Gynecological Oncology Group-neurotoxicity version 4 questionnaire. Pairwise comparisons between arms will be made as desirable, adjusting for multiple comparisons using the Bonferroni approach. Similar linear regression and LMM analyses will be carried out for the QOL and function measures.
Function and balance	Up to 10 weeks	Will be measured by the Timed Up and Go test, the Single Limb Stance, and the Activities-Specific Balance Confidence Scale. Pairwise comparisons between arms will be made as desirable, adjusting for multiple comparisons using the Bonferroni approach. Similar linear regression and LMM analyses will be carried out for the QOL and function measures.
Baseline treatment expectations	Baseline	Baseline treatment expectations will be assessed as a predictor of the secondary measures at week 10.
Quality and intensity of neuropathic pain	At 10 weeks	Will be measured by Pain Quality Assessment Scale (PQAS). To estimate the efficacy of the massage treatments at 10 weeks, linear regression will be used with PQAS as the dependent variable, massage site and schedule being two binary independent variables with interaction, adjusting for appropriate covariates such as the baseline value of PQAS. To assess the efficacy of the massage treatments over time linear mixed models (LMMs) will be used.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States