Effects of Massage Therapy on Peripheral Neuropathy and Quality of Life

NCT05433246 | Completed

• 1 other identifier: 2011/211
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

Peripheral Neuropathy,; Chemotherapy; Massage; Life Quality; Colorectal Cancer

Outcome Measures

Primary Outcomes (5)

• 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)

  16 week

• 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).

  16 weeks

• 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".

  16 weeks

• 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.

  16 weeks

• 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.

  16 weeks

Study Arms (2)

Control Group

NO INTERVENTION

The patients received routine care.

Massage therapy group

EXPERIMENTAL

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

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.

Massage therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fatma Arikan: lead

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Feray Gökdogan, PhD, RN

  Cyprus International University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, PhD

Study Record Dates

• First Submitted: June 11, 2022
• First Posted: June 27, 2022
• Study Start: February 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share