Benefit Evaluation of Foot Reflexology in Oncology (REFYO-R)
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|ClinicalTrials.gov Identifier: NCT03508180|
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : June 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer and Cancer of Digestive System||Behavioral: INTERVIONNAL Other: CONTROL||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Study Assessing the Benefits of Foot Reflexology in Patients With Gastrointestinal or Thoracic Cancer With Chemotherapy|
|Actual Study Start Date :||June 14, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: foot reflexology
patients WITH 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.
Placebo Comparator: platinum-based treatment
Patients WITHOUT ANY foot reflexology session during chemotherapy treatments
- Evaluation of nausea and vomiting [ Time Frame: 6 hours ]
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
- Nausea and vomiting between each chemotherapy [ Time Frame: Day 0, between day 14 and day 21, between day 28 and day 42, between day 42 and day 63. ]Between each chemotherapy the patient notes daily whether or not he has had nausea on a notebook.
- Quality of life [ Time Frame: Between day 0 and day 78 ]
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.
- Anxiety [ Time Frame: Between day 0 and day 78 ]
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
- Body image [ Time Frame: Day 0 ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508180
|Contact: Pierre-Jean SOUQUET, MD||04 78 86 44 00 ext +firstname.lastname@example.org|
|Centre Hospitalier Lyon Sud||Recruiting|
|Contact: Pierre-Jean SOUQUET, MD 04 78 86 44 00 ext +33 email@example.com|
|Principal Investigator: Pierre-Jean SOUQUET, MD|
|Principal Investigator:||Pierre-Jean SOUQUET, MD||Hospices Civils de Lyon|