The Effect of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients With Digestive or Lung Cancer: Randomized Controlled Trial.

cancer chemotherapy complementary and alternative medicine foot reflexology nausea and vomiting randomized controlled trial

Journal

JMIR cancer
ISSN: 2369-1999
Titre abrégé: JMIR Cancer
Pays: Canada
ID NLM: 101666844

Informations de publication

Date de publication:
05 Nov 2021
Historique:
received: 10 11 2020
accepted: 25 09 2021
revised: 14 06 2021
entrez: 5 11 2021
pubmed: 6 11 2021
medline: 6 11 2021
Statut: epublish

Résumé

Cancer is a chronic disease with an incidence of 24.5 million and 9.6 million deaths worldwide in 2017. Lung and colorectal cancer are the most common cancers for both sexes and, according to national and international recommendations, platinum-based chemotherapy is the reference adjuvant treatment. This chemotherapy can be moderately to highly emetogenic. Despite antiemetic therapy, chemotherapy-induced nausea and vomiting (CINV) may persist. Moreover, cancer patients are increasingly interested in alternative and complementary medicines and have expressed the desire that nonpharmacological treatments be used in hospitals. Among alternative and complementary medicines, foot reflexology significantly decreases the severity of CINV in patients with breast cancer. The primary aim of this study was to assess the benefits of foot reflexology as a complement therapy to conventional treatments regarding the severity of acute CINV in patients with digestive or lung cancer. The secondary objectives assessed were the frequency and severity of delayed CINV, quality of life, anxiety, and self-esteem. This study was conducted between April 2018 and April 2020 in the Hospices Civils de Lyon, France. This was an open-label randomized controlled trial. Participants were randomized into two groups: the intervention group (ie, conventional care with foot reflexology; n=40) and the control group (ie, conventional care without foot reflexology; n=40). Foot reflexology sessions (30 minutes each) were performed on outpatients or inpatients. Eligible participants were patients with lung or digestive cancer with an indication for platinum-based chemotherapy. The severity of acute nausea and vomiting was assessed with a visual analog scale during the second cycle of chemotherapy. A significant increase of at least 2 points was observed for the control group (7/34, 21%; P=.001). Across all cycles, the foot reflexology group showed a trend toward less frequent delayed nausea (P=.28), a significantly less frequent consumption of antiemetic drugs (P=.04), and no significant difference for vomiting (P=.99); there was a trend toward a perception of stronger severity for delayed nausea in the control group (P=.39). Regarding quality of life and anxiety, there was no significant difference between the intervention group and the control group (P=.32 and P=.53, respectively). This study's results indicate that foot reflexology provides significantly better management of acute nausea severity and decreased consumption of antiemetic drugs in patients with lung or digestive cancer. In order to fulfill patients' desires to use nonpharmacological treatments and complementary and alternative medicines in hospitals, foot reflexology could be provided as a complementary intervention to conventional antiemetic drugs. Foot reflexology did not result in adverse effects. To assess the benefits of foot reflexology in routine practice, a larger study with several health care centers would be needed with a cluster randomized controlled trial. ClinicalTrials.gov NCT03508180; https://clinicaltrials.gov/ct2/show/NCT03508180. RR2-10.2196/17232.

Sections du résumé

BACKGROUND BACKGROUND
Cancer is a chronic disease with an incidence of 24.5 million and 9.6 million deaths worldwide in 2017. Lung and colorectal cancer are the most common cancers for both sexes and, according to national and international recommendations, platinum-based chemotherapy is the reference adjuvant treatment. This chemotherapy can be moderately to highly emetogenic. Despite antiemetic therapy, chemotherapy-induced nausea and vomiting (CINV) may persist. Moreover, cancer patients are increasingly interested in alternative and complementary medicines and have expressed the desire that nonpharmacological treatments be used in hospitals. Among alternative and complementary medicines, foot reflexology significantly decreases the severity of CINV in patients with breast cancer.
OBJECTIVE OBJECTIVE
The primary aim of this study was to assess the benefits of foot reflexology as a complement therapy to conventional treatments regarding the severity of acute CINV in patients with digestive or lung cancer. The secondary objectives assessed were the frequency and severity of delayed CINV, quality of life, anxiety, and self-esteem.
METHODS METHODS
This study was conducted between April 2018 and April 2020 in the Hospices Civils de Lyon, France. This was an open-label randomized controlled trial. Participants were randomized into two groups: the intervention group (ie, conventional care with foot reflexology; n=40) and the control group (ie, conventional care without foot reflexology; n=40). Foot reflexology sessions (30 minutes each) were performed on outpatients or inpatients. Eligible participants were patients with lung or digestive cancer with an indication for platinum-based chemotherapy.
RESULTS RESULTS
The severity of acute nausea and vomiting was assessed with a visual analog scale during the second cycle of chemotherapy. A significant increase of at least 2 points was observed for the control group (7/34, 21%; P=.001). Across all cycles, the foot reflexology group showed a trend toward less frequent delayed nausea (P=.28), a significantly less frequent consumption of antiemetic drugs (P=.04), and no significant difference for vomiting (P=.99); there was a trend toward a perception of stronger severity for delayed nausea in the control group (P=.39). Regarding quality of life and anxiety, there was no significant difference between the intervention group and the control group (P=.32 and P=.53, respectively).
CONCLUSIONS CONCLUSIONS
This study's results indicate that foot reflexology provides significantly better management of acute nausea severity and decreased consumption of antiemetic drugs in patients with lung or digestive cancer. In order to fulfill patients' desires to use nonpharmacological treatments and complementary and alternative medicines in hospitals, foot reflexology could be provided as a complementary intervention to conventional antiemetic drugs. Foot reflexology did not result in adverse effects. To assess the benefits of foot reflexology in routine practice, a larger study with several health care centers would be needed with a cluster randomized controlled trial.
TRIAL REGISTRATION BACKGROUND
ClinicalTrials.gov NCT03508180; https://clinicaltrials.gov/ct2/show/NCT03508180.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) UNASSIGNED
RR2-10.2196/17232.

Identifiants

pubmed: 34738909
pii: v7i4e25648
doi: 10.2196/25648
pmc: PMC8663669
doi:

Banques de données

ClinicalTrials.gov
['NCT03508180']

Types de publication

Journal Article

Langues

eng

Pagination

e25648

Informations de copyright

©Audrey Murat-Ringot, Pierre Jean Souquet, Fabien Subtil, Florent Boutitie, Marie Preau, Vincent Piriou. Originally published in JMIR Cancer (https://cancer.jmir.org), 05.11.2021.

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Auteurs

Audrey Murat-Ringot (A)

Hôpital Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France.
INSERM U1290, Research on Healthcare Performance, Claude Bernard University I, Lyon, France.
Groupe de Recherche en Psychologie Sociale EA 4163, Institut de Psychologie, Université Lyon 2, Bron, France.

Pierre Jean Souquet (PJ)

Hôpital Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France.

Fabien Subtil (F)

Pôle Santé Publique - Service de Biostatistiques, Hospices Civils de Lyon, Lyon, France.
Biometrics and Evolutionary Biology UMR 5558, Claude Bernard University I, Centre national de la recherche scientifique, Villeurbanne, France.

Florent Boutitie (F)

Pôle Santé Publique - Service de Biostatistiques, Hospices Civils de Lyon, Lyon, France.

Marie Preau (M)

Groupe de Recherche en Psychologie Sociale EA 4163, Institut de Psychologie, Université Lyon 2, Bron, France.

Vincent Piriou (V)

Hôpital Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France.
INSERM U1290, Research on Healthcare Performance, Claude Bernard University I, Lyon, France.

Classifications MeSH