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

Not Applicable

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Other: Foot reflexology

• Registration Number: NCT06251297
• Lead Sponsor: University Hospital, Toulouse

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-09
• Study Start: 2024-04-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-05-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reflexology session	Foot reflexology	Patients included in the study and treated with oxaliplatin based regiment will receive 30-min of a standard reflexology session during each infusion for a maximum of 12 sessions over 6 months).

Primary Outcome Measures

Name	Time	Method
number of sessions performed	6 months	at least 50% of patients included and realized at least 70% of reflexology sessions over the 6-month treatment.

Secondary Outcome Measures

Name	Time	Method
concordance of peripheral neuropathy evaluation	every month until 6 months	peripheral neuropathy evaluation between physician's assessment and programming nurse's assessment

Trial Locations

Locations (1)

CHU de Toulouse; 🇫🇷 Toulouse, CHU de Toulouse, France