Reflexology or Aromatherapy Massage in Relieving Symptoms in Patients With Cancer

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217424
• Other study ID #: CDR0000686459
• Secondary ID: RMNHS-REFLEXOLOG
• Status: Completed
• Phase: N/A
• First received: October 7, 2010
• Last updated: October 31, 2016
• Start date: October 2010
• Est. completion date: November 2011

Study information

• Verified date: October 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain
• Psychosocial Effects of Cancer and Its Treatment
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• questionnaire administration

Procedure:
• aromatherapy and essential oils

• management of therapy complications

• massage therapy

• psychosocial assessment and care

• reflexology procedure

Locations

Country	Name	City	State
United Kingdom	Royal Marsden - London	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)			No
Secondary	Difference of 2 points of concern scores in MYCAW questionnaire			No
Secondary	Difference in MYCAW overall well-being score			No
Secondary	Change over time in pre-session Visual Analogue Scale (VAS) relaxation score (long-term relaxation benefit)			No
Secondary	Change in pre- to post-session VAS relaxation score (short-term relaxation benefit)			No
Secondary	Percentage of patients gaining benefit from the intervention defined as improvement by at least 1 point in all answered MYCAW scales			No