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Not yet recruitingNCT07884071AYU-STEPUpdated Oct 20, 2026

AYUrvedic Foot Massage for Symtoms of Taxane-induced Peripheral nEuroPathy

An interventional study of Manual manipulation of the feet. in Chemotherapy-induced Peripheral Neuropathy (CIPN), sponsored by European Institute of Oncology. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by European Institute of Oncology · Not applicable, Interventional, and Treatment

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Chemotherapy-induced Peripheral Neuropathy (CIPN)
03

In context

Lead sponsor

European Institute of Oncology is the lead sponsor of 184 studies on the registry; 117 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Treatment arm

    Manual manipulation of the feet

    Procedure: Manual manipulation of the feet.

Interventions

  • ProcedureManual manipulation of the feet.

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to the follow-up contact at 10 weeks

  2. 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.

    Time frame: From enrollment to the follow-up contact at 10 weeks

Secondary outcomes

  1. 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.

    Time frame: From enrollment to the follow-up contact at 10 weeks

  2. 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.

    Time frame: From enrollment to the follow-up contact at 10 weeks

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Study locations

1 site
  • European Institute of Oncology
    Milan, 20141, Italy
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07884071
Responsible party
Sponsor
First posted
Oct 20, 2026
Start date
Oct 2026 (estimated)
Primary completion
Dec 2030 (estimated)
Completion
Jan 2031 (estimated)
Last update
Oct 20, 2026

Study contacts

Irene Feroce
Contact
irene.feroce@ieo.it
+39 0257489551

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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