Back to resultsMassage Therapy in Reducing Chemotherapy-Induced Peripheral Neuropathy in Patients With Gastrointestinal or Breast Malignancies
Primary Purpose
Malignant Breast Neoplasm, Malignant Digestive System Neoplasm, Peripheral Neuropathy
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Massage Therapy
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Malignant Breast Neoplasm
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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
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)
Arm Description
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.
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.
Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder thrice weekly for 4 weeks.
Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder twice weekly for 6 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Baseline treatment expectations
Baseline treatment expectations will be assessed as a predictor of the secondary measures at week 10.
Full Information
NCT ID
NCT02221700
First Posted
August 19, 2014
Last Updated
September 19, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02221700
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 9, 2015 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Breast Neoplasm, Malignant Digestive System Neoplasm, Peripheral Neuropathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group I (leg massage 3 x weekly for 4 weeks)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (leg massage 2 x weekly for 6 weeks)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group III (head/neck/shoulder massage 3 x weekly for 4 weeks)
Arm Type
Experimental
Arm Description
Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder thrice weekly for 4 weeks.
Arm Title
Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)
Arm Type
Experimental
Arm Description
Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder twice weekly for 6 weeks.
Intervention Type
Procedure
Intervention Name(s)
Massage Therapy
Other Intervention Name(s)
Massage
Intervention Description
Undergo massage therapy
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Completion Rates of Two Massage Treatment Protocols for Patients With Chronic, Oxaliplatin-Induced Peripheral Neuropathy
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Quality and intensity of neuropathic pain
Description
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.
Time Frame
At 10 weeks
Title
Quality of life (QOL)
Description
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.
Time Frame
Up to 10 weeks
Title
Function and balance
Description
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.
Time Frame
Up to 10 weeks
Title
Symptoms associated specifically with chemotherapy-induced peripheral neuropathy
Description
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.
Time Frame
Up to 10 weeks
Title
Baseline treatment expectations
Description
Baseline treatment expectations will be assessed as a predictor of the secondary measures at week 10.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Lopez
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
Massage Therapy in Reducing Chemotherapy-Induced Peripheral Neuropathy in Patients With Gastrointestinal or Breast Malignancies
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