Clinical trial NCT05433246: Effects of Massage Therapy on Peripheral Neuropathy and Quality of Life
Official title: Effect of Massage Therapy on Peripheral Neuropathy and Life Quality of Colorectal Cancer wıth Patient Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: Peripheral Neuropathy,
Chemotherapy
Massage
Life Quality
Colorectal Cancer
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this randomized controlled experimental study was to determine the effect of massage applied to colorectal cancer patients receiving chemotherapy on peripheral neuropathy and quality of life.

Detailed description: The aim of this randomized controlled experimental study was to determine the effect of massage applied to colorectal cancer patients receiving chemotherapy on peripheral neuropathy and quality of life.Investigation was carried out between February 2012- May 2013 with 52 patients meeting study criteria and receiving chemotherapy in Akdeniz University outpatient chemotherapy unit (28 study group, 24 control).

Massage therapy group:The experimental group patients were given a series of effleurage, petrissage and surface fraction types of classical massage on local parts of they're body-below, elbow-frontal arm-hand (20 minutes) and below knee-leg (lower part)-foot (20 minutes) two days of treatment of 16 times total.The patients in the massage group received 16 sessions of classical massage performed by the research nurse, who had classical massage training and certification.Baseline, patient characteristics , peripheral neuropathy symptoms, neuropathic pain, cancer and chemotherapy-related symptoms, and quality of life were completed. Peripheral neuropathy symptoms, cancer, and chemotherapy-related symptoms were assessed at each cycle (2th, 4th, 6th, 8th,10th,12th,14th, 16th. week- (two-week intervals)). Neuropathic pain and quality of life were measured at 4, 10, and 16 weeks. At week 16 (2 weeks after the intervention), the grade of peripheral sensory neuropathy was determined.

Control Group: The patients received routine care. Baseline, patient characteristics , peripheral neuropathy symptoms, neuropathic pain, cancer and chemotherapy-related symptoms, and quality of life were completed. Peripheral neuropathy symptoms, cancer, and chemotherapy-related symptoms were assessed at each cycle (2th, 4th, 6th, 8th,10th,12th,14th, 16th. week (two-week intervals)). Neuropathic pain and quality of life were measured at 4, 10, and 16 weeks. At week 16 (2 weeks after the intervention), the grade of peripheral sensory neuropathy was determined.

Eligibility criteria: Inclusion Criteria:

* over 18 years old
* have a diagnosis of colorectal cancer
* receiving FOLFOX-4 chemotherapy protocol
* to receive a maximum of 4 cycles of FOLFOX-4 chemotherapy
* platelet values over -100.000/mm3
* no obstacle to massage application

Exclusion Criteria:

* previously been diagnosed with polyneuropathy,
* has been diagnosed with diabetes,
* is addicted to alcohol,
* has been amputated at the extremities,
* has a skin infection and skin integrity disorder,
* has megaloblastic anemia, uses anticoagulants,
* takes drugs that hide or affect neuropathy findings
* has had massage therapy within the last month.

Primary outcomes:
measure: Peripheral Neuropathy Evaluation Form
timeFrame: 16 week
measure: Self-Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (S-LANSS)
timeFrame: 16 weeks
measure: MD Anderson Symptom Inventory
timeFrame: 16 weeks
measure: European Organisation for Research and Treatment of Cancer-Quality of Life Scale
timeFrame: 16 weeks
measure: American National Cancer Institute Cancer Therapy Evaluation Program Common Toxicity Criteria, Version 2.0
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cyprus International University
name: Feray Gökdogan, PhD, RN
role: STUDY_CHAIR
References: