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

Peripheral Neuropathy Clinical Trial

Official title:

A Pilot Study of Massage for Symptom Reduction in Chemotherapy-Induced Peripheral Neuropathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02221700
• Other study ID #: 2014-0250
• Secondary ID: NCI-2015-0038620
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 9, 2015
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Malignant Breast Neoplasm
• Malignant Digestive System Neoplasm
• Neoplasms
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Procedure:
• Massage Therapy
Undergo massage therapy

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality and intensity of neuropathic pain	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.	At 10 weeks
Secondary	Quality of life (QOL)	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.	Up to 10 weeks
Secondary	Function and balance	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.	Up to 10 weeks
Secondary	Symptoms associated specifically with chemotherapy-induced peripheral neuropathy	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.	Up to 10 weeks
Secondary	Baseline treatment expectations	Baseline treatment expectations will be assessed as a predictor of the secondary measures at week 10.	Baseline

External Links

•   University of Texas MD Anderson Cancer Center Website