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CompletedNCT05433246Updated Jul 20, 2023

Effects of Massage Therapy on Peripheral Neuropathy and Quality of Life

An interventional study of Massage therapy group in Chemotherapy-induced Peripheral Neuropathy, sponsored by Fatma Arikan. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-20.

Sponsored by Fatma Arikan · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 10 years 4 months after the study started (first participant enrolled Feb 2012, registered Jun 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chemotherapy-induced Peripheral Neuropathy

Keywords

  • Peripheral Neuropathy,
  • Chemotherapy
  • Massage
  • Life Quality
  • Colorectal Cancer
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 52 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

This is the only study on the registry with Fatma Arikan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • No intervention
    Control Group

    The patients received routine care.

  • Experimental
    Massage therapy group

    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.

    Behavioral: Massage therapy group

Interventions

  • BehavioralMassage therapy group

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 16 week

  2. 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).

    Time frame: 16 weeks

  3. 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".

    Time frame: 16 weeks

  4. 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.

    Time frame: 16 weeks

  5. 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.

    Time frame: 16 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05433246
Lead sponsor
Fatma Arikan
Responsible party
Fatma Arikan (Assistant Professor, PhD, Akdeniz University) — Sponsor-investigator
First posted
Jun 27, 2022
Start date
Feb 1, 2012
Primary completion
May 1, 2013
Completion
May 1, 2013
Last update
Jul 20, 2023

Study contacts

Feray Gökdogan, PhD, RN
study chair · Cyprus International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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