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Effects of Massage Therapy on Peripheral Neuropathy and Quality of Life

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Massage therapy group
Sponsored by
Fatma Arikan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy-induced Peripheral Neuropathy focused on measuring Peripheral Neuropathy,, Chemotherapy, Massage, Life Quality, Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control Group

    Massage therapy group

    Arm Description

    The patients received routine care.

    The patients in the massage group were given classical massage for 2 consecutive days in each chemotherapy cycle (with an interval of two weeks). Massage therapy was performed with a classical massage technique using effleurage, petrissage, and superficial friction techniques for a total of 40 minutes on the areas below the elbow-forearm-hand (20 minutes), and below the knee-lower leg-foot (20 minutes). The patients in the massage group received 16 sessions of classical massage performed by the research nurse, who had classical massage training and certification.

    Outcomes

    Primary Outcome Measures

    Peripheral Neuropathy Evaluation Form
    It was developed by the researcher by reviewing the literature in order to determine the symptoms of peripheral neuropathy in the upper and lower extremities of the patients (0=no symptoms, 4=very severe)
    Self-Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (S-LANSS)
    This scale measures neuropathic pain.The first five items of the scale show pain symptoms, while the last two items show allodynia and pinprick test self-report. A score of twelve points or more is considered as neuropathic pain (neuropathic pain yes:12 and higher).
    MD Anderson Symptom Inventory
    The scale includes symptoms (13 items), and measures how much the symptoms have interfered with six daily activities (general activity, mood, work, relations with others, walking, and enjoyment of life.) A high score indicates an increase in the severity of the symptom and negative impact on life. The rates the severity of symptoms with a score of 0-10, 0 "none" and 10 "as bad as you can imagine" over the past 24 hours.Interference is rated on a 0-10 numerical rating scale, 0 being "did not interfere" and 10 being "interfered completely." A score range of 5-6 is considered "moderate" and a range of 7-10 is considered "severe".
    European Organisation for Research and Treatment of Cancer-Quality of Life Scale
    It measures the quality of life of individuals diagnosed with cancer. This scale consists of three parts: general health, functional health and symptoms, and a total of 30 questions ((minimum score: 0 maximum score: 100).A high score indicates a high quality of life. Low scores on functional health (physical, role, emotional, cognitive, and social functions) and general health scales indicate poor quality of life. Low scores on the symptom subscale indicate higher quality of life.
    American National Cancer Institute Cancer Therapy Evaluation Program Common Toxicity Criteria, Version 2.0
    It was used to grade Peripheral Neuropathy-sensory (minimum score: 0; maximum score: 4). Grade 0: Normal, no symptoms, Grade 4: permanent loss of sensation and impaired function. High grades indicate the height of the symptom severity.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 11, 2022
    Last Updated
    July 19, 2023
    Sponsor
    Fatma Arikan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05433246
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2012 (Actual)
    Primary Completion Date
    May 1, 2013 (Actual)
    Study Completion Date
    May 1, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Fatma Arikan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chemotherapy-induced Peripheral Neuropathy
    Keywords
    Peripheral Neuropathy,, Chemotherapy, Massage, Life Quality, Colorectal Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    The patients received routine care.
    Arm Title
    Massage therapy group
    Arm Type
    Experimental
    Arm Description
    The patients in the massage group were given classical massage for 2 consecutive days in each chemotherapy cycle (with an interval of two weeks). Massage therapy was performed with a classical massage technique using effleurage, petrissage, and superficial friction techniques for a total of 40 minutes on the areas below the elbow-forearm-hand (20 minutes), and below the knee-lower leg-foot (20 minutes). The patients in the massage group received 16 sessions of classical massage performed by the research nurse, who had classical massage training and certification.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Massage therapy group
    Intervention Description
    Massage therapy was performed with a classical massage technique using effleurage, petrissage, and superficial friction techniques for a total of 40 minutes on the areas below the elbow-forearm-hand (20 minutes), and below the knee-lower leg-foot (20 minutes). The patients in the massage group received 16 sessions of classical massage performed by the research nurse, who had classical massage training and certification.
    Primary Outcome Measure Information:
    Title
    Peripheral Neuropathy Evaluation Form
    Description
    It was developed by the researcher by reviewing the literature in order to determine the symptoms of peripheral neuropathy in the upper and lower extremities of the patients (0=no symptoms, 4=very severe)
    Time Frame
    16 week
    Title
    Self-Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (S-LANSS)
    Description
    This scale measures neuropathic pain.The first five items of the scale show pain symptoms, while the last two items show allodynia and pinprick test self-report. A score of twelve points or more is considered as neuropathic pain (neuropathic pain yes:12 and higher).
    Time Frame
    16 weeks
    Title
    MD Anderson Symptom Inventory
    Description
    The scale includes symptoms (13 items), and measures how much the symptoms have interfered with six daily activities (general activity, mood, work, relations with others, walking, and enjoyment of life.) A high score indicates an increase in the severity of the symptom and negative impact on life. The rates the severity of symptoms with a score of 0-10, 0 "none" and 10 "as bad as you can imagine" over the past 24 hours.Interference is rated on a 0-10 numerical rating scale, 0 being "did not interfere" and 10 being "interfered completely." A score range of 5-6 is considered "moderate" and a range of 7-10 is considered "severe".
    Time Frame
    16 weeks
    Title
    European Organisation for Research and Treatment of Cancer-Quality of Life Scale
    Description
    It measures the quality of life of individuals diagnosed with cancer. This scale consists of three parts: general health, functional health and symptoms, and a total of 30 questions ((minimum score: 0 maximum score: 100).A high score indicates a high quality of life. Low scores on functional health (physical, role, emotional, cognitive, and social functions) and general health scales indicate poor quality of life. Low scores on the symptom subscale indicate higher quality of life.
    Time Frame
    16 weeks
    Title
    American National Cancer Institute Cancer Therapy Evaluation Program Common Toxicity Criteria, Version 2.0
    Description
    It was used to grade Peripheral Neuropathy-sensory (minimum score: 0; maximum score: 4). Grade 0: Normal, no symptoms, Grade 4: permanent loss of sensation and impaired function. High grades indicate the height of the symptom severity.
    Time Frame
    16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Feray Gökdogan, PhD, RN
    Organizational Affiliation
    Cyprus International University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effects of Massage Therapy on Peripheral Neuropathy and Quality of Life

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