To hear about similar clinical trials, please enter your email below
Trial Title:
Feasibility and Benefits of Reflexology in the Prevention of Neuropathy Induced by Oxaliplatin in Colorectal Cancer
NCT ID:
NCT06251297
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
oxaliplatin
reflexology
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
All patients will receive a 30-minute reflexology session during each Oxaliplatin
infusion.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Foot reflexology
Description:
30 minutes reflexology session
Arm group label:
Reflexology session
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Toulouse
Address:
City:
Toulouse
Zip:
31059
Country:
France
Start date:
May 26, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
University Hospital, Toulouse
Agency class:
Other
Source:
University Hospital, Toulouse
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06251297
