Trials / Active Not Recruiting
Active Not RecruitingNCT02221700
Massage Therapy in Reducing Chemotherapy-Induced Peripheral Neuropathy in Patients With Gastrointestinal or Breast Malignancies
A Pilot Study of Massage for Symptom Reduction in Chemotherapy-Induced Peripheral Neuropathy
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Massage Therapy | Undergo massage therapy |
| OTHER | Quality-of-Life Assessment | Ancillary studies |
| OTHER | Questionnaire Administration | Ancillary studies |
Timeline
- Start date
- 2015-04-09
- Primary completion
- 2027-04-30
- Completion
- 2027-04-30
- First posted
- 2014-08-20
- Last updated
- 2026-03-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02221700. Inclusion in this directory is not an endorsement.