Massage Therapy for Peripheral Neuropathy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must be taking: CIPN medications

Disqualifiers: Diabetes, DVT, Bone metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 4-6 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Gabriel Lopez

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for English-speaking patients who have had gastrointestinal or breast cancer and received specific chemotherapy drugs, causing nerve problems. They must be stable on current neuropathy medications and able to visit the MD Anderson Main Campus in Texas. Pregnant women, those with low blood counts, a history of deep vein thrombosis within the last year, diabetes, or other causes of neuropathy are excluded.

Inclusion Criteria

It has been 6 months or more since my last chemotherapy.

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

Exclusion Criteria

I have had a blood clot in my leg, bone cancer spread, skin infection, or swelling in the treatment area recently.

Your blood platelet count has been below 50,000 within the last 6 months.

Your neutrophil count has been less than 500 in the last 6 months before the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo massage therapy for chemotherapy-induced peripheral neuropathy, with different protocols: thrice weekly for 4 weeks or twice weekly for 6 weeks

4-6 weeks

12 visits (in-person) for 4 weeks protocol, 12 visits (in-person) for 6 weeks protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Massage Therapy

Trial Overview The study is testing if massage therapy can help reduce nerve pain and improve life quality for patients who developed peripheral neuropathy from chemotherapy treatments for gastrointestinal or breast cancers. It involves regular visits to receive massages and completing questionnaires about their symptoms.

Participant Groups

Group I: Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks) Experimental Treatment 3 Interventions

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

Group II: Group III (head/neck/shoulder massage 3 x weekly for 4 weeks) Experimental Treatment 3 Interventions

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

Group III: Group II (leg massage 2 x weekly for 6 weeks) Experimental Treatment 3 Interventions

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 IV: Group I (leg massage 3 x weekly for 4 weeks) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+