Lung Cancer and Cancer of Digestive System Clinical Trial
— REFYO-ROfficial title:
Randomized Study Assessing the Benefits of Foot Reflexology in Patients With Gastrointestinal or Thoracic Cancer With Chemotherapy
| Verified date | May 2021 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | April 8, 2020 |
| Est. primary completion date | February 3, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patient with a thoracic or digestive cancer with indication of management with platinum salts-based chemotherapy - Good performance status of (ECOG 0-2) - More than 18 years old - Ability to complete the questionnaires (comprehension oral and written French language) and to carry out the required exercises. - Patient affiliated to Social Security or equivalent - Informed consent signed Exclusion Criteria: - Phlebitis - Cellar syndrome - Weight loss> 5% in 3 months - Uncontrolled pain - Patients under morphine and derivatives - Brain metastases - Patient benefiting from foot reflexology outside the study - Patient under guardianship or curatorship or deprived of his rights |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Lyon Sud | Pierre-Bénite |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of nausea and vomiting | 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 |
6 hours | |
| Secondary | Nausea and vomiting between each chemotherapy | Between each chemotherapy the patient notes daily whether or not he has had nausea on a notebook. | Day 0, between day 14 and day 21, between day 28 and day 42, between day 42 and day 63. | |
| Secondary | Quality of life | 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. |
Between day 0 and day 78 | |
| Secondary | Anxiety | 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 |
Between day 0 and day 78 | |
| Secondary | Body image | 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 |
Day 0 |