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Completed

NCT Number: NCT01217424

Reflexology or Aromatherapy Massage in Relieving Symptoms in Patients With Cancer

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychosocial Effects of Cancer and Its Treatment Signs and Symptoms Unspecified Adult Solid Tumor, Protocol Specific

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Questionnaire Administration

Other

Aromatherapy and Essential Oils

Procedure

management of therapy complications

Procedure

Massage therapy

Procedure

psychosocial assessment and care

Procedure

reflexology procedure

Procedure

Primary outcomes

  1. 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 outcomes

  1. Difference of 2 points of concern scores in MYCAW questionnaire

  2. Difference in MYCAW overall well-being score

  3. Change over time in pre-session Visual Analogue Scale (VAS) relaxation score (long-term relaxation benefit)

  4. Change in pre- to post-session VAS relaxation score (short-term relaxation benefit)

  5. Percentage of patients gaining benefit from the intervention defined as improvement by at least 1 point in all answered MYCAW scales

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 8, 2010
Registry last updated
Nov 1, 2016

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.

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