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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
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