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

NCT ID: NCT06251297

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-29
• Study Completion Date: 2026-12-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Reflexology session

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).

Group Type: EXPERIMENTAL

Foot reflexology

Intervention Type: OTHER

30 minutes reflexology session

Interventions

Foot reflexology

30 minutes reflexology session

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadim FARES, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU de Toulouse

Toulouse, CHU de Toulouse, France

Site Status: RECRUITING

Countries

France

Central Contacts

Nadim FARES, MD

Role: CONTACT

fares.n@chu-toulouse.fr

05 61 32 21 42 ext. 33

Facility Contacts

Nadim FARES, MD

Role: primary

fares.n@chu-toulouse.fr

05 61 32 21 42 ext. 33

Caroline GREGOIRE

Role: backup

gregoire.c@chu-toulouse.fr

05 61 32 21 88 ext. 33

Other Identifiers

RC31/22/0041

Identifier Type: -

Identifier Source: org_study_id