A Pilot Study of Massage for Symptom Reduction in Chemotherapy-Induced Peripheral Neuropathy
概览
- 阶段
- 不适用
- 干预措施
- Massage Therapy
- 疾病 / 适应症
- Malignant Breast Neoplasm
- 发起方
- M.D. Anderson Cancer Center
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Completion Rates of Two Massage Treatment Protocols for Patients With Chronic, Oxaliplatin-Induced Peripheral Neuropathy
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group III (head/neck/shoulder massage 3 x weekly for 4 weeks)
Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder thrice weekly for 4 weeks.
干预措施: Massage Therapy
Group I (leg massage 3 x weekly for 4 weeks)
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.
干预措施: Massage Therapy
Group I (leg massage 3 x weekly for 4 weeks)
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.
干预措施: Quality-of-Life Assessment
Group I (leg massage 3 x weekly for 4 weeks)
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.
干预措施: Questionnaire Administration
Group II (leg massage 2 x weekly for 6 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.
干预措施: Massage Therapy
Group II (leg massage 2 x weekly for 6 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.
干预措施: Quality-of-Life Assessment
Group II (leg massage 2 x weekly for 6 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.
干预措施: Questionnaire Administration
Group III (head/neck/shoulder massage 3 x weekly for 4 weeks)
Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder thrice weekly for 4 weeks.
干预措施: Quality-of-Life Assessment
Group III (head/neck/shoulder massage 3 x weekly for 4 weeks)
Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder thrice weekly for 4 weeks.
干预措施: Questionnaire Administration
Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)
Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder twice weekly for 6 weeks.
干预措施: Massage Therapy
Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)
Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder twice weekly for 6 weeks.
干预措施: Quality-of-Life Assessment
Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)
Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder twice weekly for 6 weeks.
干预措施: Questionnaire Administration
结局指标
主要结局
Completion Rates of Two Massage Treatment Protocols for Patients With Chronic, Oxaliplatin-Induced Peripheral Neuropathy
时间窗: 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.
次要结局
- Quality of life (QOL)(Up to 10 weeks)
- Symptoms associated specifically with chemotherapy-induced peripheral neuropathy(Up to 10 weeks)
- Function and balance(Up to 10 weeks)
- Baseline treatment expectations(Baseline)
- Quality and intensity of neuropathic pain(At 10 weeks)