Skip to main content
OpenTrials
Completed

NCT Number: NCT05433246

Effects of Massage Therapy on Peripheral Neuropathy and Quality of Life

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Massage therapy group

Behavioral

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 outcomes

  1. Peripheral Neuropathy Evaluation Form

    Time frame: 16 week

    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)

  2. Self-Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (S-LANSS)

    Time frame: 16 weeks

    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).

  3. MD Anderson Symptom Inventory

    Time frame: 16 weeks

    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".

  4. European Organisation for Research and Treatment of Cancer-Quality of Life Scale

    Time frame: 16 weeks

    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.

  5. American National Cancer Institute Cancer Therapy Evaluation Program Common Toxicity Criteria, Version 2.0

    Time frame: 16 weeks

    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.

Sponsors and collaborators

Lead sponsor

Fatma Arikan

Other

Registry information

Official study title

Effect of Massage Therapy on Peripheral Neuropathy and Life Quality of Colorectal Cancer wıth Patient Receiving Chemotherapy

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 27, 2022
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.