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NCT Number: NCT06251297

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Foot reflexology

Other

30 minutes reflexology session

Primary outcomes

  1. number of sessions performed

    Time frame: 6 months

    at least 50% of patients included and realized at least 70% of reflexology sessions over the 6-month treatment.

Secondary outcomes

  1. concordance of peripheral neuropathy evaluation

    Time frame: every month until 6 months

    peripheral neuropathy evaluation between physician's assessment and programming nurse's assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Nadim FARES, MD

CONTACT

[email protected]

05 61 32 21 42 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: FIRENOX

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2024
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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