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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508180
|Contact: Pierre-Jean SOUQUET, MD||04 78 86 44 00 ext +email@example.com|
|Centre Hospitalier Lyon Sud||Recruiting|
|Contact: Pierre-Jean SOUQUET, MD 04 78 86 44 00 ext +33 firstname.lastname@example.org|
|Principal Investigator: Pierre-Jean SOUQUET, MD|
|Principal Investigator:||Pierre-Jean SOUQUET, MD||Hospices Civils de Lyon|