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Recruiting NCT06251297

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

No phase Interventional Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Foot reflexology.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Foot reflexology
    30 minutes reflexology session

Primary outcome measures

  • number of sessions performed [Time frame: 6 months]
Secondary outcome measures (1)
  • concordance of peripheral neuropathy evaluation [Time frame: every month until 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • CHU de Toulouse — Toulouse

Identifiers

NCT: NCT06251297 · RC31/22/0041

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗