Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Lung Neoplasms

Nausea

Vomiting

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

patients WITH foot reflexology session during chemotherapy treatments

Patients WITHOUT ANY foot reflexology session during chemotherapy treatments

Foot reflexology session (30 minutes) each course of chemotherapy (total 4 courses) during the 4 hours following the first 2 hours of injection + auto-massage done by the patient between each course.

During a session focused on the treatment of nausea / vomiting, the reflexologist will stimulate the reflex zones related to the digestive system in order to calm and stimulate all areas for deep relaxation of the patient.

INTERVIONNAL

CONTROL

Pierre-Jean SOUQUET, MD

Chemotherapy with platinum salts is very emetic. The aim of this study is to evaluate the benefits of foot reflexology in nausea and vomiting induced by platinum salts-based chemotherapy in patients with thoracic or digestive tumors.

Benefit Evaluation of Foot Reflexology in Oncology

Randomized Study Assessing the Benefits of Foot Reflexology in Patients With Gastrointestinal or Thoracic Cancer With Chemotherapy

The relative change in VAS\* associated with nausea and vomiting will be evaluated between T1 (measured at least 2 hours after the start of chemotherapy injection) and T2 (measured at least 6 hours after the start of injection of the drug chemotherapy).

\*VAS : from 0 to 10 ; 0 is no nausea or vomiting and 10 is insufferable nausea or vomiting

Between each chemotherapy the patient notes daily whether or not he has had nausea on a notebook.

Relative variation of the EORTC QLQC 30\* (European Organisation for Research and Treatment of Cancer) between the inclusion visit (V2) and the end-of-study visit (V6).

\*EORTC QLQ C30 : All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

Relative variation of the HADS\* (Hospital and Anxiety Depression Scale) anxiety score between the inclusion visit (V2) and the end-of-study visit (V6).

\*HADS : 0 to 21, the highest scores corresponding to the presence of a more severe symptomatology

Evaluation of the body image to the end-of-study visit by the Body Image Questionnaire\* (BIC), which measures the body image at a given moment t. The analysis will take into account the self-esteem assessed upon the inclusion visit on the Rosenberg scale\*\* (V2).

\*BIC : The total score is between 19 and 95.

\*\*Rosenberg Scale : The total score ranges from 10 to 40. A score below 31 is considered low self-esteem

Hospices Civils de Lyon

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Patients included in the study and treated with oxaliplatin based regiment will receive 30-min of a standard reflexology session during each infusion for a maximum of 12 sessions over 6 months).

Foot reflexology

Nadim FARES, MD

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.

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.

All patients will receive a 30-minute reflexology session during each Oxaliplatin infusion.

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Benefit Evaluation of Foot Reflexology in Oncology	NCT03508180	Lung Cancer and...	INTERVIONNAL CONTROL	18 Years -	Hospices Civils de Lyon
Feasibility and Benefits of Reflexology in the Prevention of Neuropathy Induced by Oxaliplatin in Colorectal Cancer	NCT06251297	Colorectal Canc...	Foot reflexolog...	18 Years -	University Hospital, Toulouse
Benefit Evaluation of Foot Reflexology in Oncology	NCT03508180	Lung Cancer and...	INTERVIONNAL CONTROL	18 Years -	Hospices Civils de Lyon
Feasibility and Benefits of Reflexology in the Prevention of Neuropathy Induced by Oxaliplatin in Colorectal Cancer	NCT06251297	Colorectal Canc...	Foot reflexolog...	18 Years -	University Hospital, Toulouse

Spots Global Cancer Trial Database for foot reflexology