Chemotherapy-induced Peripheral Neuropathy (CIPN)AYU-STEPNCT07884071
AYUrvedic Foot Massage for Symtoms of Taxane-induced Peripheral nEuroPathy
A study testing Manual manipulation of the feet. in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by European Institute of Oncology at 1 site in Italy.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) affects approximately 40% of patients treated with taxanes. These agents may cause burning pain, paresthesia, numbness, and loss of proprioceptive sensitivity, which can reduce well-being and impair quality of life.In this context, implementing non-pharmacological… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy (CIPN)
- What is being tested?
- Manual manipulation of the feet.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2026to Jan 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 anni
- Diagnosis of carcinoma with ongoing treatment or treatment completed within the previous 6 months with taxanes (paclitaxel/docetaxel).
- Grade 1-2 sensory-motor peripheral neuropathy (NCI-CTCAE v5).
- Able to walk independently.
- Written informed consent.
Who cannot join
- Pre-existing diabetic neuropathy
- Foot ulcers or infections
- Central neurological disorders
- Concomitant specific treatment for CINP including other complementary medicine. Occasional over the counter drugs such as NSIDs or pain killer are allowed. Any other clinical condition that, at the discretion of the physician or practitioner, may contraindicate participation in the study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
European Institute of Oncology
Milan, 20141
Irene Feroce, 0257489551, irene.feroce@ieo.it
About this study
Official title: Effect of AYUrvedic Foot Massage for Symtoms of Taxane-induced Peripheral nEuroPathy: Prospective Pilot Study
Chemotherapy-induced peripheral neuropathy (CIPN) affects approximately 40% of patients treated with taxanes. These agents may cause burning pain, paresthesia, numbness, and loss of proprioceptive sensitivity, which can reduce well-being and impair quality of life.In this context, implementing non-pharmacological interventions, such as foot treatment/manipulation proposed in this project, represents a promising area to explore complementary therapies with minimal toxicity and low cost for symptom management.
- Being tested
- Manual manipulation of the feet.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual manipulation of the feet.Procedure or surgery
The treatment consists of manual manipulation of the feet using Mahanarayan oil. Each session lasts approximately 30-40 minutes and is performed with the patient in a supine position, including massage of the foot and lower leg.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Manual manipulation of the feet Receives: Procedure: Manual manipulation of the feet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that completed the treatment
Adherence to treatment will be measured as the number of subjects that completed all study treatment sessions on the total number of subjects enrolled.
Measured: From enrollment to the follow-up contact at 10 weeks
Incidence of local adverse events related to the use of medicated oils during treatement sessions or manual therapy.
Incidence will be calculated as the number of local adverse events related to the use of medicated oils during treatement sessions or manual therapy on the total number of treatment sessions administered.
Measured: From enrollment to the follow-up contact at 10 weeks
Secondary outcomes (2)
Change from baseline in the score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-Item Scale (QLQ-CIPN20) at 10 weeks.
Impact of treatment on Chemotherapy-induced peripheral neuropathy (CIPN) will be assessed using the QLQ-CIPN20 questionnaire.
The QLQ-CIPN20 questionnaire will be administered four times: before the first treatment, at mid-treatment, at the end of treatment, and at follow-up.
Higher the resulting score mean higher the CIPN affect the patient. Impact of treatment will be defined by the comparison of initial scoring and post treatment scoring.
Measured: From enrollment to the follow-up contact at 10 weeks
Change from baseline in the score of The McGill Pain Questionnaire (P.R.I.) at 10 weeks.
The McGill Pain Questionnaire (P.R.I.) will be administered before the first treatment, at the end of the treatment, and at follow-up.
Higher the resulting score mean higher the paint felt by the patient. Impact of treatment on the reduction of the pain will be defined by the comparison of initial scoring and post treatment scoring.
Measured: From enrollment to the follow-up contact at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884071
- Sponsor's protocol ID
- UID 5323
- Other IDs
- L2-657
- Acronym
- AYU-STEP
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No