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

NCT06251297 | Recruiting

• 1 other identifier: RC31/22/0041
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

oxaliplatin; reflexology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• concordance of peripheral neuropathy evaluation

  every month until 6 months

Study Arms (1)

Reflexology session

EXPERIMENTAL

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).

Other: Foot reflexology

Interventions

Foot reflexology OTHER

30 minutes reflexology session

Reflexology session

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU de Toulouse

Toulouse, CHU de Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Nadim FARES, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadim FARES, MD

CONTACT

05 61 32 21 42; fares.n@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients will receive a 30-minute reflexology session during each Oxaliplatin infusion.

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 9, 2024
• Study Start: April 29, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)