Malignant Breast NeoplasmNCT02221700
Massage Therapy in Reducing Chemotherapy-Induced Peripheral Neuropathy in Patients With Gastrointestinal or Breast Malignancies
A study testing Massage Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Malignant Breast Neoplasm and Malignant Digestive System Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Breast Neoplasm, Malignant Digestive System Neoplasm, Peripheral Neuropathy
- What is being tested?
- Massage Therapy, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2015to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Massage for Symptom Reduction in Chemotherapy-Induced Peripheral Neuropathy
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.
Read the 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:
- 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.
- Being tested
- Massage Therapy, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms, Gastrointestinal Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage TherapyProcedure or surgery
Also called Massage
Undergo massage therapy
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Massage Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (5)
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.
Measured: At 10 weeks
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.
Measured: Up to 10 weeks
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.
Measured: Up to 10 weeks
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.
Measured: Up to 10 weeks
Baseline treatment expectations
Baseline treatment expectations will be assessed as a predictor of the secondary measures at week 10.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study start9 Apr 2015
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gabriel Lopez, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221700
- Sponsor's protocol ID
- 2014-0250
- Other IDs
- NCI-2015-00386, 2014-0250
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2014
- Last updated
- 18 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Massage for Symptom Reduction in Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT02221700
- Acronym / sponsor ID
- 2014-0250
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Apr 2015 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I (leg massage 3 x weekly for 4 weeks) | Experimental | Procedure: Massage Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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) | Experimental | Procedure: Massage Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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) | Experimental | Procedure: Massage Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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) | Experimental | Procedure: Massage Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo massage therapy over 30 minutes to the head, neck, and shoulder twice weekly for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage TherapyAlso: MassageUndergo massage therapy | Procedure or surgery | 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) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | 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 AdministrationAncillary studies | Other | 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) |
Primary outcome
Completion Rates of Two Massage Treatment Protocols for Patients With Chronic, Oxaliplatin-Induced Peripheral Neuropathy
Time frame: 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.
5 secondary outcomes
Quality and intensity of neuropathic pain
Time frame: At 10 weeks
Quality of life (QOL)
Time frame: Up to 10 weeks
Function and balance
Time frame: Up to 10 weeks
Symptoms associated specifically with chemotherapy-induced peripheral neuropathy
Time frame: Up to 10 weeks
Baseline treatment expectations
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Lopez principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Malignant Breast Neoplasm and Malignant Digestive System Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rates of Two Massage Treatment Protocols for Patients With Chronic, Oxaliplatin-Induced Peripheral Neuropathy (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.