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

Toulouse University Hospital

Status: Enrolling

Conditions: Colorectal Cancer

Treatments: Other: Foot reflexology

Study type: Interventional

Funder types: Other

Identifiers

NCT06251297

RC31/22/0041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Reflexology session

Experimental group

Description:

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).

Treatment:

Other: Foot reflexology