Reflexology or Aromatherapy Massage in Relieving Symptoms in Patients With Cancer

October 31, 2016 updated by: Royal Marsden NHS Foundation Trust

Is Reflexology as Effective as Aromatherapy Massage for Symptom Relief in an Outpatient Oncology Population?

RATIONALE: Reflexology and aromatherapy massage may lessen symptoms in patients with cancer. It is not yet known whether reflexology is more effective than aromatherapy massage in relieving symptoms in patients with cancer.

PURPOSE: This randomized clinical trial is studying reflexology to see how well it works compared with aromatherapy massage in relieving symptoms in patients with cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To determine whether reflexology is as effective as aromatherapy massage for alleviation of self-selected symptoms in patients with cancer in an outpatient setting.

Secondary

  • To determine the difference between the two therapies with respect to Visual Analogue Scale (VAS) relaxation scores before and after each treatment.

OUTLINE: Patients are stratified according to gender (male vs female), treatment (chemotherapy vs other) and their first concern choice (pain vs other). Patients are randomized to 1 of 2 intervention arms.

  • Arm I (Reflexology): Patients undergo 45-60 minutes of reflexology for 4 sessions.
  • Arm II (Aromatherapy massage): Patients undergo 45-60 minutes of of aromatherapy massage for 4 sessions.

Patients complete questionnaires (Measure Yourself Concerns and Well-being [MYCAW] questionnaire and Visual Analogue Scale [VAS]) at baseline, before and after each session, and after completion of all four sessions.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, SW3 6JJ
        • Royal Marsden - London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Any patient receiving treatment for cancer at the Royal Marsden NHS Foundation Trust Hospital

    • Must be attending the hospital as an outpatient
  • Planning to access complementary therapy

PATIENT CHARACTERISTICS:

  • No excessive pain in both hands and both feet

  • Not experiencing a combination of conditions affecting both hands and both feet which would prevent reflexology of either hands or feet from taking place, including any of the following:

    • Deep vein thrombosis
    • Lymphedema
    • Infected or broken skin
    • Recent scars or injuries
    • Phlebitis
    • Areas currently receiving radiotherapy (or received radiotherapy in the past 2 weeks)
  • Able and willing to attend the hospital for four 1-hour sessions

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 2 months since prior and no other concurrent massage therapy or reflexology at the Royal Marsden NHS Foundation Trust Hospital or from another practitioner
  • Not planning to undergo massage therapy or reflexology while also taking part in this study
  • At least 2 months since prior and no other concurrent massage therapy at the Royal Marsden NHS Foundation Trust Hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Difference of 1 point of concern scores in Measure Yourself Concerns and Well-being (MYCAW) questionnaire from baseline to second evaluation (after completion of all four sessions of therapy)

Secondary Outcome Measures

Outcome Measure
Difference of 2 points of concern scores in MYCAW questionnaire
Difference in MYCAW overall well-being score
Change over time in pre-session Visual Analogue Scale (VAS) relaxation score (long-term relaxation benefit)
Change in pre- to post-session VAS relaxation score (short-term relaxation benefit)
Percentage of patients gaining benefit from the intervention defined as improvement by at least 1 point in all answered MYCAW scales

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Clare Shaw, MD, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

October 7, 2010

First Submitted That Met QC Criteria

October 7, 2010

First Posted (ESTIMATE)

October 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CDR0000686459
  • RMNHS-REFLEXOLOGY
  • EU-21075
  • MREC-10/H0801/31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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