Feasibility and Benefits of Reflexology in the Prevention of Neuropathy Induced by Oxaliplatin in Colorectal Cancer

Colorectal Cancer Clinical Trial

— FIRENOX  

Official title:

Feasibility and Benefits of Reflexology in the Prevention of Neuropathy Induced by Oxaliplatin in Colorectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06251297
• Other study ID #: RC31/22/0041
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 26, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The management of colorectal cancer often requires oxaliplatin-based chemotherapy, either as part of curative treatment plans or exclusively in palliative situations. Oxaliplatin therefore plays a key role in the management of colorectal cancer. In addition to its digestive and hematological toxicity, oxaliplatin frequently induces chronic, often limiting, sensitive peripheral neuropathy. Only early discontinuation of oxaliplatin can limit the risk of clinically limiting neurotoxicity (grade ≥ 3). In oncology, managing the side-effects of treatment is an essential objective of supportive care, and is open to a variety of complementary medicines, including reflexology. This technique, derived from traditional Chinese medicine, involves stimulating reflex points on the arch of the foot.

Description:

This first monocentric, prospective pilot study is designed to evaluate if the intervention is feasible in routine clinical practice for patients initiating bimonthly oxaliplatin chemotherapy for colorectal cancer. It will also provide initial estimates of the parameters needed to measure efficacy and impact on patient quality of life. Patients will receive a reflexology session with each cycle of chemotherapy, and will be assessed during all the treatment period.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age>18 years treated for colorectal cancer in Digestive Oncology service Rangueil hospital
• Initiation of intravenous oxaliplatin chemotherapy at 85 mg/m² on a bimonthly schedule.
• Ability to understand and answer a self-questionnaire.
• Life expectancy egal or over 12 weeks
• Signed informed consent form

Exclusion Criteria:

• Pre-existing motor and/or sensitive neuropathy.
• Reflexology treatment within the last 6 months.
• Contraindication to reflexology: venous thrombosis, trauma, wound or metastasis of the foot.
• Patient covered by a legal protection scheme.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Foot reflexology
30 minutes reflexology session

Locations

Country	Name	City	State
France	CHU de Toulouse	Toulouse	CHU De Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of sessions performed	at least 50% of patients included and realized at least 70% of reflexology sessions over the 6-month treatment.	6 months
Secondary	concordance of peripheral neuropathy evaluation	peripheral neuropathy evaluation between physician's assessment and programming nurse's assessment	every month until 6 months